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

Model Number	ETLW1613C93E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Injury (2348)
Date of Event	09/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exact date of event unknown.Film evaluation summary: the cause of the reported occlusion also could not be determined, but may have been caused by the reported stent graft narro wing due to the anatomy of the common iliac.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
An endurant iis stent graft system was implanted in a patient for the endovascular treatment of an abdominal aortic aneurysm of unknown size.It was reported on an unknown date a non-mdt stent was placed in the stent graft limb etlw1613c93e on an unknown date as there was narrowing of the stent due to the anatomy of the common iliac.Per the physician, the cause of the event cannot be determined.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the thrombus observed within the right limb could not be determined from the limited films provided.Pre-implant anatomy is unknown, and images during implant <(>&<)> current ct¿s were not available for review.It is possible that this was anatomy related due to stent graft placement within a constricted/calcified anatomy, with possible resulting stent graft compression and/or kinking.This may also have been caused by a patient condition: poor distal runoff, an unknown coagulopathy that is now presenting, or a previous history of pad.The cause of the earlier reported occlusion also could not be determined, but may have been caused by the reported stent graft narrowing due to the anatomy of the common iliac.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: 7998938
• Report Number: 2953200-2018-01501
• Device Sequence Number: 1311860
• Product Code: MIH
• UDI-Device Identifier: 00643169467682
• UDI-Public: 00643169467682
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2017
• Device Model Number: ETLW1613C93E
• Device Catalogue Number: ETLW1613C93E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Initial Date Received by Manufacturer: 10/04/2018
• Supplement Date Received by Manufacturer: 10/19/2018
• Initial Report FDA Received Date: 10/24/2018
• Supplement Report FDA Received Date: 11/09/2018
• 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: 85 YR