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

Model Number	ETLW1613C156E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	08/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 of a 52mm diameter abdominal aortic aneurysm.It was reported that the patient presented emergently approximately 1 year 3 months post implant with claudication and left limb pain.Ct was performed and showed left stent graft limb occlusion.It was noted that anatomy showed narrowing of the distal end of the stent graft and limited outflow in the left eia.As per the physician, the cause of the event was anatomy related.No additional clinical sequelae were reported and the patient will be monitored.
Additional Manufacturer Narrative
Film evaluation summary: the cause of the reported left limb occlusion seen 15 months post-implant could not be determined from the pre-implant films provided.Images during implant and post-implant were not available for review, and the reported occlusion and stent graft in-vivo configuration could not be assessed.It is likely that the reported stent graft narrowing at the distal end of the left limb within the calcified left common iliac artery caused the left limb to occlude.The calcified and small caliber distal aorta may have also been a factor.Other potential patient condition issues such as poor distal runoff, an unknown coagulopathy that is now presenting, or a previous history of pad, may have also contributed to the occlusion.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: 8953531
• Report Number: 9612164-2019-03685
• Device Sequence Number: 19547900
• Product Code: MIH
• UDI-Device Identifier: 00643169467583
• UDI-Public: 00643169467583
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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: 12/04/2019
• Device Model Number: ETLW1613C156E
• Device Catalogue Number: ETLW1613C156E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 09/02/2019
• Supplement Report FDA Received Date: 10/21/2019
• 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: Other
• Patient Age: 67 YR