Medtronic Endurant Manual Del Usuario página 22

2011/DEC/22 at 7:46 p.m. Doc number: M716803B001 [multi23]
iliac extension component and the component it is inserted into. Follow the contralateral limb component
deployment steps described in Section 9.7.9.
9.7.11. Abdominal Tube Component
In the event that an abdominal tube component needs to be used, follow the bifurcated component
deployment steps with the following exception. Rotate the handle to open the tube component entirely
before releasing the proximal end of the suprarenal stent of the tube component.
9.7.12. AUI Component
Follow the bifurcated component deployment steps, except rotate the handle to open the AUI component
graft covered section entirely before releasing the proximal end of the suprarenal stent of the AUI
component. Follow the steps described in Section 9.7.6 through Section 9.7.8 to remove the delivery
system.
In the event that a distal component is required, use the contralateral limb component as the AUI distal
extension. Place the delivery system over the existing guidewire, and follow the contralateral limb
component deployment steps described in Section 9.7.9. To ensure proper docking, align the proximal
radiopaque markers of the contralateral limb component with the AUI component radiopaque marker at
the third stent of the distal section.
An occluder may be used to block flow through the contralateral iliac artery. Refer to Section 9.7.13 and
the Talent Abdominal Stent Graft System Instructions for Use.
9.7.13. Occluder Deployment
The Talent Occluder System is available to be used with Endurant Stent Graft System and is typically
used in conjunction with the AUI component. The Talent Occluder System is closed at both ends to stop
retrograde blood flow into the aneurysm sac.
For details on use and implantation of the Talent Occluder System, refer to the appropriate sections of the
"Talent Abdominal Stent Graft System Instructions for Use".
9.7.14. Smoothing Stent Graft Fabric and Modeling the Assembled Stent Graft
Components
The Reliant Stent Graft Balloon Catheter is packaged separately. This compliant balloon can be used to
assist in stent graft implantation by modeling the covered portion of the stent graft components and to
remove wrinkles and folds from the graft material as needed. Use the Reliant Stent Graft Balloon Catheter
to model the proximal and distal seal zones as well as any overlapping connection (or junction) areas
between the components of the Endurant Stent Graft System. Sub-optimal expansion of the self-
expanding stent graft components may also be improved by use of the Reliant Stent Graft Balloon
Catheter.
Follow the Reliant Stent Graft Balloon Catheter IFU for specific insertion instructions.
Note: The Reliant Balloon is recommended for use with the Endurant Stent Graft System. Data is not
available for use with other balloons for remodeling stent grafts.
Caution: Over inflation of balloon can cause graft tears and/or vessel dissection or rupture.
Warning: WHEN EXPANDING A VASCULAR PROSTHESIS, THERE IS AN INCREASED RISK OF
VESSEL INJURY AND/OR RUPTURE, AND POSSIBLE PATIENT DEATH, IF THE BALLOON'S
PROXIMAL AND DISTAL RADIOPAQUE MARKERS ARE NOT COMPLETELY WITHIN THE COVERED
(GRAFT FABRIC) PORTION OF THE PROSTHESIS.
Warning: DO NOT USE THE RELIANT STENT GRAFT BALLOON CATHETER IN THE TREATMENT
OF DISSECTIONS.
9.7.15. Seal Entry Sites
Remove the introducer and the guidewire. Repair the entry site with standard closure technique.
9.7.16. Procedure Completion
At the completion of the procedure, perform angiography to assess the Endurant Stent Graft components
for proximal and distal endoleaks and to verify position of the implanted stent graft components in relation
to the aneurysm and renal arteries. Leaks at the attachment or connection sites should be treated using
the balloon to remodel the stent graft components against the vessel wall. Major leaks that cannot be
corrected by re-ballooning may be treated by adding Endurant Aortic or Iliac Extension Components to
the previously placed stent graft components.
Caution: Any leak left untreated during the implantation procedure must be carefully monitored after
implantation.
9.8. Bail Out Techniques
9.8.1. Screw Gear Handle Disassembly
In the unlikely event of delivery system failure and concomitant partial stent graft component deployment
due to graft cover severance, a "screw gear handle disassembly" technique may permit the successful
deployment of the stent graft. See the instructions below.
•
Pull back the trigger and fully retract the slider.
•
Stabilize the delivery system.
•
Insert the tips of a pair of hemostats into each of the screw gear handle disassembly ports on
the front grip.
•
Disengage the front grip from the screw gear by pressing the tips of the hemostats into the handle
disassembly ports and simultaneously advancing the front grip away from the screw gear.
•
Advance the front grip until it fully clears the screw gear.
• Separate the screw gear halves in order to identify the location of graft cover severance.
•
Manually retract the graft cover with your fingers or with hemostats until the stent graft is fully
deployed.
•
Follow the standard instruction for use for tip capture section deployment and delivery system
removal.
9.8.2. Ballooning
In the unlikely event of delivery system failure and the captured proximal end of crowns and anchoring
pins of the suprarenal stent cannot be deployed while the back-end wheel section still works (the stent
graft component being deployed moves together with taper tip when turning the back-end wheel), a
"ballooning" technique may permit the successful deployment of the captured proximal end of crowns and
anchoring pins of the suprarenal stent. See the instructions below.
•
Use a compliant or semi-compliant balloon (Reliant Balloon recommended).
•
Insert the balloon and move it to the bifurcated (or other anchor pin containing) stent graft
component aortic (or equivalent) section.
•
Inflate the balloon inside the stent graft component aortic section to the vessel size to stabilize
the stent graft.
•
Follow the standard instruction for use for tip capture deployment and delivery system removal.
9.8.3. Back-end Handle Disassembly
In the unlikely event of delivery system failure and concomitant no or partial deployment of the proximal
end of crowns and anchoring pins of the suprarenal stent due to back-end wheel failure, a "back-end
handle disassembly" technique will permit the successful deployment of the proximal end of crowns and
anchoring pins of the suprarenal stent. See the instructions below.
•
Separate the wheel halves. If wheel contains exposed tabs, use hemostats to depress the tabs
to disassemble. Otherwise, a blade or other object may be used to pry the halves apart.
•
Insert the tips of hemostats into each of the rear handle disassembly ports.
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