MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDURANT II ILIAC STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	ETLW1620C82E
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Codes	Occlusion (1984); Pain (1994)
Date of Event	03/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant ii stent graft system was implanted in a patient for the endovascular treatment an abdominal aortic aneurysm.It was reported that the patient presented to the hospital with left leg pain.A ct scan showed occlusion due to stenosis of the endurant stent grafts in the left limb.The patient received an intervention.The physician performed a cut down on the left common femoral artery, inserted a guidewire and catheter that were advanced up to the occlusion.The physician used an angiojet to declot the occlusion in the left limb.The completion angiogram should the endurant stent grafts were patent with no complication.The physician reviewed the one month ct scan and noted two areas of stenosis at the end of the endurant bifurcated stent graft and the middle of the endurant iliac limb which resulted in the occlusion of the endurant stent grafts.Per the primary physician, the cause of the occlusions and stenosis was due to the patient¿s anatomy.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Corrected information: sex, date of birth.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENDURANT II ILIAC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 6651283
• Report Number: 2953200-2017-01005
• Device Sequence Number: 13774393
• Product Code: MIH
• UDI-Device Identifier: 00643169467521
• UDI-Public: 00643169467521
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2017
• Device Model Number: ETLW1620C82E
• Device Catalogue Number: ETLW1620C82E
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/26/2017
• Supplement Date Received by Manufacturer: 05/26/2017
• Initial Report FDA Received Date: 06/19/2017
• Supplement Report FDA Received Date: 10/04/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 61 YR