Potential Adverse Events - Medtronic Endurant Manual Del Usuario

2011/DEC/22 at 7:46 p.m. Doc number: M716803B001 [multi23]
with latex containing products (e.g. handling of the Endurant Stent Graft System by operators
wearing latex gloves).
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Potential anatomical limitations (e.g. small access vessels) need to be recognized.
•
The use of this device requires administration of radiographic agents. Patients with pre-existing
renal insufficiency may have an increased risk of renal failure postoperatively.
•
Proper use of this device requires accurate fluoroscopic imaging. This device is not
recommended for patients whose weight may impede accurate fluoroscopic imaging.
•
Regular follow-up including imaging of the device should be performed in accordance with the
standard of care of the treating hospital/ physician. Patients should be monitored for aneurysm
size, occlusion of vessels, pulsatility, migration, leaks, and device integrity.
•
Additional treatment including endovascular treatment or surgical conversion should be
considered in the following cases:
Aneurysm growth > 5 mm (with or without leak) since last follow-up
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Change in aneurysm pulsatility (with or without growth or leak)
■
Persistent endoleak with or without aneurysm growth
■
Stent graft migration resulting in an inadequate seal zone
■
Decrease in renal function due to renal artery occlusion (migration or poor placement).
■
In all above mentioned cases, the treating physician should on a case by case basis and in
accordance with the standard of care decide an appropriate action.
4.3. Clinical Use
•
Pre-operative planning for access and placement should be performed before opening the device
packaging.
•
Carefully inspect the Endurant Stent Graft System packaging and device for damage or defects
prior to use. Do not use product if any sign of damage or breach of the sterile barrier is observed.
Do not attempt to resterilize the Endurant Delivery System or the Endurant Stent Graft.
•
Do not bend or kink the Endurant Delivery System prior to implantation because it may cause
deployment difficulties.
•
To prevent thrombotic problems, an additional bolus of IV heparin should be administered before
inserting the device.
•
Do not deploy the Endurant Stent Graft Components in a location that will occlude arteries
necessary to supply blood flow to organs or extremities.
•
Always use fluoroscopic guidance to advance the Endurant Delivery System. Do not use
excessive force to advance or withdraw the Endurant Delivery System when resistance is
encountered.
•
Do not continue to torque the delivery system without tip response.
•
Exercise particular care in areas of stenosis, intravascular thrombosis, or in calcified or tortuous
vessels. Perform balloon angioplasty at the site of a narrowed or stenotic vessel, and then attempt
to gently reintroduce the catheter delivery system.
•
Always monitor the implant procedure under fluoroscopy to detect kinking or alignment problems
with the Endurant Stent Graft. If the Endurant Delivery System kinks during insertion, do not
attempt to deploy the Endurant Stent Graft. Remove the system and insert a new delivery system.
•
Inadequate seal zone may result in increased risk of leakage into the aneurysm or migration of
the stent graft.
•
The Endurant Stent Graft cannot be replaced or drawn back into the Endurant Delivery System,
even if the stent graft is only partially deployed.
•
If the graft cover is accidentally withdrawn, the device will prematurely deploy and may be
incorrectly positioned.
•
Improper placement may result in leakage or occlusion, necessitating surgical removal of the
device.
•
When using the trigger to rapidly deploy the stent graft, be sure to hold the front grip of the delivery
system stationary. Do not rotate the handle during this step.
•
If a balloon catheter is used, do not over inflate or inflate outside the graft material. Follow all
manufacturer instructions regarding catheter operation.
5. Adverse Events

5.1. Potential Adverse Events

Potential risks or adverse events associated with use of the Endurant Stent Graft System are similar to
those known to occur with conventional open surgical repair of Abdominal Aortic Aneurysm (AAA). Such
risks may be related to use of the device, the implant procedure, anesthesia, or the attendant equipment
and supplies.
Refer to Table 1 for a list of potential risks that may occur with use of the Endurant Stent Graft System
and its associated procedures. The occurrence of these listed adverse events may lead to the need for a
repeat endovascular intervention and/or open surgical repair.
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