IFU AAA_neu-04-2008

IFU AAA_neu-04-2008
Gebrauchsanweisung
Instruction for use
Instrucciones de uso
Mode d’emploi
Istruzioni per l'uso
Instrukcja uŜycia
Instruções de utilização
2
S. 3
English
S. 18
S. 33
S. 48
Italiano
S. 63
S. 78
S. 93
Vor
dem
lesen.
Mainbody (MB)
•
3
Mainbody
Ipsilaterales Bein
Abb. 1: E-vita abdominal Mainbody und kontralaterales Bein
Komponenten
des
AAA
sind
folgende
•
Iliakale Extension (IE)
Nahtmaterial
ist
mit
PTFE
PET.
Zur
besseren
4
Hüllkatheter
•
•
5
Toughy Borst
Ventil
PU Markerband
Kontrollgriff
Markerpunkt
Abb. 2: E-vita abdominal Stentgraft System
6
2.0 Indikation
•
•
7
•
•
•
•
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Punktionsnadel
•
•
Kontrastmittel
•
•
•
Ballonkatheter Reliant der Firma Medtronic
6.0 Heparinisierung und Thrombozytenaggregationshemmung
8
Toughy Borst
Ventil
Markerpunkt
9
Ringmarker
Abb. 6: Mainbody
10
Ringmarker
Ringmarker kontralaterales Bein
11
Proximale
Halslängen
eines
Aortenaneurysmas
unter
15mm
das
Risiko
einer
12
13
14
9.0
•
Tod
•
•
Perforation der Aorta
•
•
•
•
•
•
•
•
•
•
•
15
10.0
MRT-Information
11.0
12.0
b)
16
Umfang.
aus
der
sind
Handhabung
durch
den
oder
der
17
Carefully read through all instructions prior to use. Adhere to any of the warnings and precautions being
listed in these instructions for use. Neglecting these may result in massive complications.
Conventional treatment of abdominal aortic aneurysms (AAA) implies a high degree of invasive surgical
effort. Like with every other complex surgery, the risk derived from surgical interventions is high.
JOTEC GmbH's endoluminal stent graft prostheses are a viable alternative to the conventional surgeries
and therapy options when treating vascular aneurysms in the abdominal aorta.
E-vita abdominal as supplied by JOTEC GmbH is a stent graft system, particularly designed for
endoluminally treating abdominal aortic aneurysms.
E-vita abdominal is made of two main components: the stent graft and the delivery system. When
being introduced into the vascular system, the stent graft is constrained by means of the catheter tube of
the delivery system. The delivery system including the loaded stent graft is pushed forward via a guide
wire until the implantation site is reached. When being deployed, the self-expanding stent graft is
released, adapting itself to form and size of the proximal as well as distal sealing zones by the radial
force of the nitinol springs.
The E-vita abdominal stent graft is a self-expanding endoluminal vascular implant which remains in the
patient's body following release. It is marked by its modular setup, consisting of the two main
components as follows:
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•
Main body (MB)
•
Main body
Bare stent End
Fig. 1: E-vita abdominal main body and contralateral leg
The main body is a bifurcation prosthesis, consisting of an aortal segment as well as a long and a short
iliac segment. The main body's long iliac segment is identified as ipsilateral leg. Following release, the
short leg is located in the aortal vascular segment and serves as starting point for the second leg, that is
the contralateral leg. The contralateral leg is exclusively made up of an iliac segment. The proximal end
of the main body holds a 15 mm high, bare (uncovered) nitinol stent spring, enabling for suprarenal
fixation of the stent graft. The following extension sleeves are available as additional components of the
AAA stent graft:
•
•
The extensions are one aortal single or iliac segment, set up cylindrically and aim at extending both main
components in proximal or distal direction. A delivery system introduces the single components into the
target vessel, the components then being connected to the segments implanted by means of
overlapping.
The E-vita abdominal stent graft is composed of self-expanding zigzag nitinol stent springs which are
durably sewed into a polyethylene therephtalate (PET) tissue deploying surgical suture material. The
nitinol stent springs' surfaces are electro-polished. PTFE-impregnated and plaited PET is used as
surgical suture material. Small gold rings are attached to the polyester tissue to allow for better x-ray
control during positioning and follow-up of the E-vita abdominal stent graft.
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1.2 Delivery system
The E-vita abdominal delivery system is comprised of a disposable catheter with integrated grip
handle for controlled and safe release. The catheter is flexible and compatible to a 0.035” (0.87mm)
guide wire. The catheter is composed of the three following concentric single-lumen polymer tubes:
•
Sheath catheter
•
Pusher tube
•
Guide wire catheter
The catheter tube surrounding the loaded stent graft can be retracted either stepwise or continuously by
means of the grip handle. Thus, the protective sheathing is removed from the release grip handle first. By
pushing the switch on the release grip handle from position P to D, the system is set to operating mode,
thereby enabling for releasing the E-vita abdominal stent graft. This is done by withdrawal of the sheath
catheter against the pusher.
PLEASE NOTE: The switch on the release grip handle is to remain in its P position until releasing
the stent graft.
The distal end of the pusher tube is equipped with a pusher ring, maintaining the stent graft in its axial
position during the release process. The distal end of the delivery system holds an atraumatic polymer tip
to allow for manoeuvring in curved and calcified vessels. The conical radiopaque tip, a marker band on
the distal end of the catheter tube as well as the radiopaque pusher ring facilitate fluoroscopic
visualisation. The delivery system is also equipped with some gaskets to ensure haemostasis.
Following complete release of the stent graft the delivery system is removed from the vascular
system.
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Toughy Borst
valve
E-vita abdominal delivery system
Release grip handle in closed position
Control grip handle
Guide wire catheter
Tip
Loaded stent graft
PU marker band
Release grip handle
Control grip handle
Marker point
Switch (possible
positions: P, D and N)
Release grip handle
Closed position (P)
Release grip handle
Opened position (D)
Lever opened
Fig. 2: E-vita abdominal stent graft system
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2.0 Indication
The E-vita abdominal stent graft was developed by JOTEC GmbH to specifically treat abdominal aortic
aneurysms. These aortic aneurysms may also be extended into the iliac artery. When intending
treatment using the E-vita abdominal stent graft system the following prerequisites are to be met:
• Appropriate morphology of the iliac or femoral access vessels
• Proximal landing zone in the aortic neck ≥ 15mm
• Angle between suprarenal aorta and aneurysm neck ≤ 60°
• Diameter of the proximal aortic neck 19mm – 29mm
• Distal landing zone of the iliac artery ≥ 15mm
• Diameter of the iliac arteries 11mm – 23mm
• Suitable vascular morphology for stent graft to be implanted
3.0 Contraindication
At the moment, none of the known contraindications are associated with this product.
Caution: The final treatment decision is left to the discretion of the physician in charge.
4.0 Specifying the size of the E-vita abdominal stent graft system
Prior to surgical intervention, dimensions as well as characteristics of the affected aorta segment and of
the accessing vessels, for example vascular diameter and condition (e.g. calcification and stenoses,
intraluminal thrombi), are to be determined by means of appropriate imaging. Spiral CT imaging with
contrast media and 3D representation is recommended. The healthy aortic segments are to be taken as
basis for measuring the vascular diameters. The diameter of the stent graft suited for the native vessel is
specified by means of "oversizing“. 20% is a standard value for the aortic anchoring zone, while 10% is
that of the iliac anchoring zone.
Caution: The treating physician is responsible for selecting the appropriate sizes.
5.0 Preparation of the abdominal stent graft process
5.1 The following equipment is required for implanting an E-vita abdominal stent graft:
•
X-ray image converter including digital angiographic functions (mobile C-arch device or
stationary angiography appliance).
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Fluoroscopic visualisation as well as the option of recording and retrieving any of the pictures.
•
Operation room in case an open surgery becomes compulsory.
Note: Only an endovascular specialist (cardiac, thoracic and vascular surgeon, interventional radiologist
or cardiologist) is to execute implant surgery. As far as personnel and organisation are
concerned, treatment should allow for simple or extended vascular access or for shifting to an
open surgery procedure, if required.
5.2 Materials required for implantation treatment (accessories)
•
Various flexible guide wires with a length of at least 180 cm
•
A super stift coated guide wire with a diameter of 0.87 mm and a minimum length of 190 cm,
preferably the JOTEC E-wire
•
Diverse angiography and angioplasty catheters
•
Puncture needle
•
Sterile insertion sheaths: 7, 8 or 9 french ( 3 french ≅ 1 mm).
•
Contrast medium
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Sterile syringes
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Heparin and heparinised physiological sodium chloride solution
•
Reliant balloon catheter (Medtronic)
6.0 Heparinisation and inhibition of platelet aggregation
In order to reduce the risk of thromboemboly the patient's blood is to be anticoagulated during surgery.
With a vascular surgery, between 5000 and 10000 IU of heparin are to be administered during operation,
depending on the specific patient weight. When heparin is not indicated, alternatives as hirudin may be
used. It is up to the physician in charge to postoperatively decide in favour of an antithrombocyte therapy
following surgery.
Please note: Insufficient heparinisation may result in thrombosis and embolism.
7.0 Preparing for implantation
The access vessel, that is the iliac or the femoral artery, is exposed using general surgical techniques. A
second access point may be utilised diagnostically to insert an angiography catheter. It is at the
discretion of the physician how to lay this access spot percutaneous femoral or brachial, etc.).
Introduce an angiography catheter via the second access point to exactly localise the implantation site.
The angiography catheter may be placed during implantation, being used for orientation.
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First of all check whether the atraumatic polymer tip of the delivery system is tightly attached to the
sheath catheter. If not, the Toughy Borst valve is slightly loosened and the tip then removed on the
proximal end of the guide wire catheter until being tightly connected to the sheath catheter. The Toughy
Borst valve is closed again afterwards. Following removal of the protective wire from the delivery system,
the lumen of the guide wire catheter as well as the sheath catheter are rinsed using heparinised sodium
chloride solution. The main body is always to be implanted first. Always check the control grip's proximal
end of the Toughy Borst valve (Fig. 3) which needs to be closed.
Toughy Borst valve
Control grip handle
Rinsing connection
Fig. 3: Control grip handle
Caution: The E-vita abdominal stent graft must not be bent or kinked without its guide wire.
Please make sure that the catheter has not been damaged. Kinks within the implantation area do
not prevent the systems release. In case of doubt, the system is to be rejected and replaced by a
new one.
7.1 Insertion of the E-vita® abdominal stent graft system
First of all the E-vita abdominal stent graft system is adjusted according to the marker point on the distal
end of the grip handle (Fig. 4). The marker point displays the short leg's position. X-ray fluoroscopy
should be executed beforehand to check the position of the short leg in the sheath catheter.
Loaded stent graft
Marker point
Fig. 4: Delivery system with loaded stent graft
The E-vita abdominal stent graft system is directly introduced into the vessel by means of a rigid, coated
0.87mm JOTEC E-wire.
Then the E-vita abdominal stent graft system is slowly pushed forward under x-ray fluoroscopy until the
implantation site is reached, the PU marker band as well as the proximal gold markers need to be
positioned within the proximal landing zone. Before finally releasing the E-vita abdominal stent graft, its
position and location are to be rechecked angiographically. Then, the image converter should be fixed
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and the release-relevant orientation points marked (road map, on-screen marking or external marking,
e.g. via needles).
Before releasing the main body, the position of the short leg is checked with the attached x-ray marker.
At release, the short leg is to be completely positioned in the aneurysm and above the contralateral iliac
artery. In case the short leg's position and the location of the contralateral iliac artery do not match, the
system has to be readjusted. For optimal transfer of the torsion forces to the tip of the delivery system
through extremely sinuous vessels, a complete withdrawal of the system is recommendable.
When having oriented the short leg, release can be commenced. With one hand, the control grip handle
is kept in a steady position, while the other hand is needed to remove the release grip's protective
sheathing. Push the release grip handle's switch to position D. The orange lever opens and the system is
ready to start the releasing process (Fig. 5).
Release grip handle
Opened position (D)
Lever opened
Fig. 5: Release grip handle
In order to release the stent graft from its proximal to its distal position, the control grip handle needs to
be maintained in the specified position with one hand, while the other is used to apply the squeeze-torelease mechanism. This squeeze-to-release mechanism is used by repeatedly raising and lowering the
orange lever on the release grip handle, thus moving the tissue sheath back stepwise to unfold the stent
graft when delivering the bifurcation prosthesis at is suprarenal position.
For correct positioning, the proximal end of the polyester tissue must be placed beneath the renal artery
when delivering the bifurcation prosthesis at its suprarenal position. The three ring markers show the end
of the polyester tissue (Fig. 6). Following release of the first stent springs, only distal repositioning of the
prosthesis is possible.
Ring marker
Ring marker
Fig. 6: Main body
Please note: The axial position of the stent graft is defined by the control grip handle.
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The release grip handle serves to completely release the main body of the stent graft. The sheath
catheter is to be withdrawn until the marker band clearly takes its position behind the pusher ring visible
on the x-ray photograph.
Finally, the release grip handle's switch is set to position N. Now fix the release grip handle and carefully
pull back the tip of the delivery system through the now released implant by means of the control grip
handle until again tightly connecting to the sheath catheter, always applying x-ray fluoroscopy. Make
sure the implant's position remains stable during the entire procedure. It must be ensured that the sheath
catheter was completely withdrawn in order to prevent the stent graft from getting caught between the
graft sheath and the conical tip. Now reset the switch to position D. Then carefully remove the closed
delivery system from the aorta. Stable positioning of the implant is to be guaranteed by fluoroscopic
control during removal of the delivery system. The guide wire must not be withdrawn or removed when
retracting the delivery system.
Now the delivery system of the contralateral leg can be prepared. The guide wire lumen as well as the
sheath catheter's lumen of the contralateral leg's delivery system are rinsed with heparinised sodium
chloride solution. The angiopgraphy catheter is taken out from the contralateral artery and replaced by a
JOTEC E-wire rigid, coated 0,035” (0.87mm) guide wire. The loaded contralateral leg of the E-vita
abdominal is directly introduced into the vessel by means of a rigid, coated 0.87mm guide wire, there
being carefully pushed forward via the guide wire.
The system is pushed forward until reaching sufficient overlapping of the contralateral leg, i.e. the distal
ring marker of the short leg and the proximal ring marker of the contralateral leg are in line (Fig. 7).
Ring marker, short leg
Ring marker, contralateral leg
Fig. 7: Main body and contralateral leg including ring markers
Following positioning of the prosthesis the control grip handle is maintained in its position with one hand.
The other hand is needed to remove the release grip's protective sheathing. Push the release grip
handle's switch to position D. The orange lever opens. The system is now ready for the releasing
operation. For releasing the stent graft to its distal position, the control grip handle is maintained in the
specified position with one hand, while the release grip handle is pulled back by repeatedly raising and
lowering the orange lever with the other hand. The stent graft is released stepwise applying the squeezeto-release mechanism. As soon as the contralateral leg is safely positioned within the overlapping area,
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the release grip handle can be pulled back until complete release without having to apply the squeeze-torelease mechanism. The main body must not be retracted during release of the contralateral leg!
Finally, the release grip handle's switch is set to position N. Now fix the release grip handle and carefully
pull back the conical tip of the delivery system through the now released implant by means of the control
grip handle until again tightly connecting to the sheath catheter, always applying x-ray fluoroscopy. Make
sure the sheath catheter was completely withdrawn in order to prevent the stent graft from getting caught
between the graft sheath and the conical tip. Now reset the switch to position D. Then slowly remove the
closed delivery system from the aorta. Stable positioning of the implant is to be guaranteed by
fluoroscopic control during removal of the delivery system. The guide wire must not be withdrawn or
removed when retracting the delivery system.
Repeated fluoroscopy is used to ensure that the position of the bifurcation main body segment remains
stable during implantation of the contralateral leg.
7.2 Pressing on the stent graft via balloon
By using a suited balloon (Reliant Ballon, Medtronic) it is possible to mould the prostheses in the aortal
or iliac landing zones to the aerterial walls, as applicable. Please adhere to the instructions for use of the
balloon applied.
8.0 Warnings and precautions
The E-vita abdominal stent graft system must not be employed for patients with whom the required preand postoperative imaging examinations can not be carried out. All patients are to be accurately
monitored and regularly checked for any change of their state of health as well as for the correct
functioning and integrity of the stent graft.
It is recommended to keep at least one internal iliac artery open in order to minimise the risk of pelvic or
intestinal ischemia.
There is a greater risk of stent graft migration for proximal aortal aneurysm neck lengths below 15mm.
Aortal aneurysm proximal neck diameters of more than 28mm may contribute to a greater risk of stent
graft migration. Proximal neck angles exceeding 60° may facilitate endoleakages.
In case of a conical run of the proximal neck, with an increase in diameter from the renal arteries to the
aneurysm by more than 3 mm, the risk of stent graft migration increases.
A diameter of the common iliac artery exceeding 20 mm when measured at the planned sealing zone
between stent graft and vessel can lead to endoleakages or further expansion. A diameter of the external
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iliac artery and iliac artery of less than 7,5 mm may completely prevent introduction of the delivery
system.
A systemic infection may lead to an infected stent graft. Allergic reactions to the contrast media applied
may hinder exact positioning of the stent graft. A therapy-resistant coagulopathy may increase the risk of
suffering from complications due to bleedings.
The risk of stent graft migration or renal or distal embolisation may be increased if the aneurysm neck is
filled with thrombi or calcified.
Distal anchoring points of the stent graft which show massive calcification or thrombous attachments
may entirely prevent stent graft placement and/or bear the risk of distal embolisation.
The E-vita abdominal stent graft system is to be implanted under sterile conditions either in an operating
room or an interventional angiographic laboratory which is designed to allow for conversion to open
surgery.
The renal arteries must be free to reduce or exclude the risk of acute renal failure and any associated
complications.
Extreme care has to be taken when manipulating wires, catheters and insertion sheaths for treatment of
aneurysms. There is the danger of dislocating emboli causing subsequent distal embolisation by
significant movements.
The quantity of contrast media applied during surgery should be kept at its absolute minimum, always
exactly monitoring and documenting the portions used.
Rather large angles between aorta and common iliac artery (more than 75°) may result in problems
releasing the stent graft. If the angle of the iliac artery exceeds 60°, this may result in the uninte ntional
overbending of the segment extension.
In case the vascular anatomy is found to be massively curved do not turn the delivery system to adjust
the contralateral leg in the stent graft as this could result in complete twisting of the entire stent graft.
Withdraw the entire system and remove it. Readjust it as desired before reintroducing it into the patient's
vessel.
The product must not be resterilised. In case the packaging shows damages or was opened outside the
sterile area, the product must no longer be used.
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The product must not be used if the proximal or distal end shows any kinks (potential transporting
damage).
Insufficient heparinisation may result in thrombosis and embolism.
Please observe whether the patient shows sensitivity or allergic reactions towards heparin and/or the
contrast media.
After use, the E-vita abdominal delivery system is to be disposed of according to the applicable hospital,
administration or authority regulations.
The switch on the release grip handle is to remain at its P position until releasing the stent graft.
Further moulding of the E-vita abdominal stent graft with a balloon is only allowed within its mantled area.
When trying to mould a free spring lacking appropriate sheathing the aortic wall may be perforated.
The complications most frequently observed when implanting endovascular stent grafts are
endoleakages. After completing the implantation treatment of the E-vita abdominal stent graft, the stent
graft is to be checked for leakages into the aneurysm. Intraoperative heparinisation may cause slight and
temporary leakages through the tissue of the prostheses. Any leakage is to be examined and further
monitored during follow-up.
Microembolisms – The risk of microembolism stands in direct relation to the duration and manipulation
intensity of the surgical intervention. Thus, excessive and prolonged endovascular manipulation ought to
be avoided.
Vascular thrombosis – Folds and uneveness within the stent graft may result in the formation of
thromboses. Thus, the stent graft can be further dilated by applying a separate balloon catheter to
minimise existing folds and uneven spots. In the course of this procedure, the balloon must not be
expanded or dilated too much. Extreme narrowing of the stent graft may lead to thromboses as well.
Migration – Stent graft migration is facilitated by selection of an inadequate size. When specifying the
suitable stent graft size, a 20% oversizing over the vascular diameter should be taken into account.
Insufficient fixation within the available aortic neck or the expansion of the proximal stent graft into a
thrombic or strongly bent vessel may give rise to stent migration as well. The attending physician is
responsible for selecting the appropriate sizes.
Vascular overstretching – In case the stent graft size was selected too large in comparison to the
vessel's diameter or a subsequent balloon manoeuvre treatment lead to an excessive dilating/moulding,
this may result in overstretching and according damages.
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Renal failure – Complete or partial obstruction of the renal artery by a wrongly placed stent graft or
stent-related embolisms can result in severe renal complications. Excess use of contrast media may
have the same consequences.
9.0
Potential complications and side effects
Complications may occur any time during or following implantation of the stent graft. Only those
physicians familiar with the possible complications may execute a corresponding therapy. Furthermore,
there may be also late complications. These should be checked at regular follow-up examinations.
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Death
•
Hypotension
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Perforation of the aorta
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Embolisms and subsequent tissue damage (and/or failure)
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Infections and pain at the vascular access point
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Pseudoaneurysm at the vascular access
•
•
Allergic reactions to the contrast media, resulting in renal failure or permanent or temporary
haemodialysis
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Cardiac infarction
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Intestinal ischemia and subsequent problems arising thereof
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Renal complications and subsequent problems arising thereof
•
•
•
Impotency
10.0
MRI information
Safety information relating to magnetic resonance imaging (MRI techniques) relate to the use of shielded
MRI systems with static magnetic fields (1.5 tesla or less), gradient magnetic fields of 20 tesla/second or
less and a maximum specific absorption rate (SAR) with a mean taken from the entire body of 1.2 W/kg
for a 30 minute visualisation procedure.
The stent graft is MRI-safe. This means that the stent graft being positioned inside the body of the patient
undergoing MRI treatment does not pose any additional risk, but may have influence on the quality of
MRI imaging depending on the pulse rate and the area intended for evaluation.
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11.0
Storage and packaging
The E-vita abdominal stent graft is a disposable EtO-sterilised product, delivered in a sterile packaging.
The product's sterility is guaranteed as long as the packaging remains intact.
The stent graft is to be stored in a dark, dry and cool place with a temperature range of 10°C to 38°C .
Direct insolation is to be avoided heat may negatively influence product functionality. Do not expose the
stent graft system to ionising radiation or ultraviolet light.
12.0
Warranty and liability limitations
JOTEC GmbH warrants that this product conforms to the legal requirements, in particular those set
forth in the EU Guidelines for Medical Products, 93/42/EWG. In case the product shows proven
material or production faults prior to expiry of its UBD, which can be traced back to production or
packaging, JOTEC GmbH will thus:
a)
replace the product with one of equal construction, or
b)
with one of identical functionality.
Each of the following conditions must be met in order to make claims within the context of this
warranty:
a)
The product must not have been used after expiry of its UBD.
b)
The fault did not initially occur after the UBD.
c)
If the product in question is a disposable product or is a product which JOTEC GmbH
designates as being for single use only, the fault must be detected at the first use.
d)
JOTEC GmbH or one of its representatives are to be immediately informed about the fault.
e)
The defective product is to be submitted to JOTEC GmbH or its representative right after the
fault had been reported.
This warranty in no way limits and applies in conjunction with any and all regulations governing
warranties on the part of the seller and the product liability laws. Besides, this warranty applies only to
the extent defined above. Additional claims arising from this warranty are excluded. This warranty as
well as the cited legal claims apply in place of, and to the exclusion of, all other warranties, either
verbal or written, express or implicit on the part of JOTEC GmbH. None of our representatives or
employees is empowered to reach differing agreements.
Due to numerous factors outside the control of JOTEC GmbH such as shipping, storage, and handling
on the part of the user, JOTEC GmbH is in particular not liable, for damages of any type resulting
directly or indirectly from the product or its employment unless said damages can be shown to be the
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®
result of a failure on the part of the product. JOTEC GmbH assumes no liability for wrongly sized
stent grafts, inappropriate use of the product or faulty placement of the E-vita abdominal stent graft.
In particular, JOTEC GmbH also does not assume liability for damages arising from resterilisation or
reusage of products being exclusively allowed for single usage or intended by JOTEC GmbH to be
utilised only once.
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1.1 Stentgraft abdominal E-vita
Mainbody (MB)
•
33
Mainbody
rama ipsilateral
•
34
•
Tubo de empuje
•
35
Válvula Toughy
Borst
Pi
Mando liberador
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37
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•
•
•
•
•
•
•
•
•
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Válvula Toughy
Borst
Stentgraft cargado
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Fig. 6: Mainbody
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Lesiones arteriales
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Impotencia
10.0
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11.0
12.0
b)
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•
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1.2
•
•
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Valve Touhy
Borst
Pointe
Ill. 2 : Système d’endoprothèse E-vita abdominal
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2.0 Indication
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•
52
•
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Divers cathéters d’angiographie et d’angioplastie
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Trocart
•
•
•
•
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Valve Touhy Borst
Ventil
54
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56
57
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9.0
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Décès
•
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Impotence
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10.0
Information IRM
11.0
12.0
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1.1 Stent graft E-vita abdominal
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63
•
64
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Tubo flessibile espulsore
•
65
Valvola Toughy
Borst
Stent graft caricato
Punta
Fig. 2: sistema stent graft E-vita abdominal
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Il
dello
stent
graft
per
il
vaso
nativo
viene
per
•
•
•
67
•
•
•
•
Ago per puntura
•
•
•
Siringhe sterili
•
•
68
Valvola Toughy Borst
Stent graft caricato
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Marcatori
anulari
Marcatori
anulari
70
Marcatore radiopaco anulare elemento
corto
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72
73
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9.0
•
Morte
•
•
•
•
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•
•
•
•
•
•
10.0
75
11.0
12.0
b)
76
77
1.0 Opis produktu
®
1.1 Stentgraft E-vita abdominal
78
•
•
Odnoga kontralateralna
Odnoga
ipsilateralna
Rys. 1: Mainbody i odnoga kontralateralna E-vita abdominal
•
79
•
•
w
jego
uwalniania.
Na
końcu
systemu
System
poza
tym
kilka
80
Rys. 2: System stentgraftu E-vita abdominal
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2.0 Wskazania
Stentgraft E-vita abdominal firmy JOTEC
®
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•
•
•
•
•
82
•
•
•
•
•
•
•
•
•
•
•
jak
chirurgii
naleŜy
83
Na
czy
z
polimeru
systemu
Toughy Borst Ventil
7.1 Wprowadzania systemu stentgraftu E-vita® abdominal
84
85
86
7.2 Dociskanie stentgraftu balonem
87
88
89
–
się
z
nasileniem
9.0
•
Zgon
•
•
Perforacja aorty
•
•
90
•
•
•
•
•
•
•
Chromanie
•
•
10.0
11.0
11.0
JOTEC
91
b)
®
stentgraftu,
produktu
lub
92
1.1 Endoprótese abdominal E-vita
Mainbody (MB) (corpo principal)
•
93
Mainbody
•
94
Cateter bainha
•
Tubo Pusher
•
95
Válvula
Toughy Borst
Ponta
96
•
97
•
•
•
•
•
•
•
•
•
•
•
Cateter balão (Medtronic ou similar)
98
Válvula Toughy Borst
Ventil
99
Fig. 6: Mainbody
100
101
102
103
104
9.0
•
Morte
•
Hipotonia
•
•
•
•
•
•
•
•
•
•
•
•
105
10.0
11.0
11.0
Garantia
b)
106
107
Bitte beachten Sie die Gebrauchsanweisung.
Please note instruction for use.
Por favor, lea las instrucciones de uso.
Respecter le mode d’emploi.
Rispettare le istruzioni per l'uso.
Proszę przestrzegać instrukcj obsługi
Tenha atenção às instruções de utilização
Nicht zur Wiederverwendung.
Not intended for reuse.
No reutilizable.
Ne pas a réutiliser
Monouso, non riutilizzare.
Nie uŜywać ponownie.
Não adequado para reutilização.
Bestellnummer.
Order number.
Número de pedido.
Référence.
Codice di ordinazione.
Numer zamówieniowy.
Número de referência.
Chargennummer.
Batch designation.
Número de lote.
Numéro de fabrication
Numero di lotto.
Oznaczenie partii.
Número de lote.
Verwendbar bis.
Expiry date.
Fecha de caducidad.
Date limite d’utilisation.
Data di scadenza.
Data waŜności.
Utilizar antes de
Herstellungsdatum.
Date of manufacture.
Fecha de fabricación.
Date de fabrication.
Data di produzione.
Data produkcji.
Data de fabrico
Sterilisation mit Ethylenoxid.
Sterilization with ethylenoxide.
Esterilización con óxido de etileno.
Stérilisation à l’oxyde d’éthylène.
Sterilizzazione con ossido di etilene.
Wyjalowiono tlenkiem etylenu.
Esterilizado com óxido de etileno
T +49 (0) 7471 / 922-0
F +49 (0) 7471 / 922-100
© Copyright by JOTEC GmbH. All rights reserved.
108
info@jotec.net
www.jotec.net
AAA/03.2008-2
Art.Nr. 902440
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