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

Model Number	ETLW1610C124E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Occlusion (1984); Claudication (2550)
Date of Event	12/09/2019
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 iis stent graft system was implanted in a patient for the endovascular treatment of a 78 mm abdominal aortic aneurysm.It was reported that the patient presented with claudication symptoms when they returned for follow up 4 months later.An ultrasound showed left limb occlusion and an angio carried out also verified the occlusion.A wire was attempted to be passed into the limb retrograde as well as antegrade without success.The angio showed a patent right and left hypogastric with collateral flow and there was flow in the lower extremities.The physician opted to not proceed with intervention but to follow the patient for the moment.As per the physician, the cause of the event was anatomy.The physician felt that the distal end of the left limb was at a tortuous part of the common iliac artery causing flow issues that did not show up in the initial completion angio or the one month follow up.No additional clinical sequelae were reported and the patient is being monitored.
Additional Manufacturer Narrative
Film evaluation summary: the exact cause of the left limb occlusion and claudication reported at ~3 months post-implant could not be determined from the films provided.Films during implant were not available and the blood flow dynamics could not be assessed from the ct¿s provided.Films from the occlusion event at 3 month were also not available and the reported event could not be assessed.It is possible that the acute vessel angulation seen at the take-off of the lcia may have contributed to the occlusion.The pre-existing aaa and iliac thrombus and calcification, as well as the small and calcified distal aorta may have been factors.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.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: 9464893
• Report Number: 9612164-2019-05148
• Device Sequence Number: 19599735
• Product Code: MIH
• UDI-Device Identifier: 00643169467644
• UDI-Public: 00643169467644
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2020

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: 12/17/2020
• Device Model Number: ETLW1610C124E
• Device Catalogue Number: ETLW1610C124E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 12/09/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 12/13/2019
• Supplement Report FDA Received Date: 01/30/2020
• 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 Weight: 66