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

Model Number	ENLW1620C124E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Abdominal Pain (1685); Rupture (2208)
Date of Event	12/31/2019
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 stent graft system was implanted for the endovascular treatment of an abdominal aortic aneurysm on the (b)(6) 2011.It was reported that the patient presented emergently to er approximately eight years and 7months post the index procedure with severe abdominal pain.A ct scan preformed early on the following confirmed a type ib endoleak on the left side.The aneurysm was noted to be 83mm in diameter.Initially the patient's condition was reported as stable but their condition deteriorated and an aneurysm rupture was confirmed.It is reported that the patient received treatment and the physician implanted a etlw1616c93e bridge limb and a etlw1628c93e limb to extend down to the left internal iliac artery (it was noted there was 91mm of uncovered lcia).The physician also implanted an etlw1624c93e limb that extended down to the right internal iliac artery (it was noted there was 20mm of uncovered rcia).It was reported that the event was resolved and seal achieved.As per the physician the cause of the event is anatomy.It is reported that the patients aneurysm sac continued to dilate over nine years and had lost seal resulting in the type ib endoleak on the left side.No additional clinical sequalae were reported and the patient is fine.

• Brand Name: ENDURANT 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: 9563248
• Report Number: 9612164-2020-00135
• Device Sequence Number: 16716094
• Product Code: MIH
• UDI-Device Identifier: 00613994761910
• UDI-Public: 00613994761910
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/08/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2013
• Device Model Number: ENLW1620C124E
• Device Catalogue Number: ENLW1620C124E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 01/08/2020
• 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: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 94