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

Model Number	ETUF3614C102E
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Obstruction of Flow (2423)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	03/27/2021
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 aui stent graft system was implanted in the patient for the endovascular treatment of a 100 mm abdominal aortic aneurysm.It was reported that approximately 47 months post index procedure, the patient presented to er with complaints of claudication and difficulty walking.It was stated that the physician felt that the original endurant ii aui stent graft previously implanted had ¿slipped¿ a few mm and appeared to create a kink between the distal end of the taper and the aui limb.On the same day, thrombectomy and angioplasty was performed and an additional etuf3614c102e was implanted two days later resulting in brisk blood flow and palpable distal pulses upon completion.As per the physician the cause of the event can not be determined.No additional clinical sequalae were reported and the patient is fine.

• Brand Name: ENDURANT II AUI STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 11711967
• Report Number: 9612164-2021-01612
• Device Sequence Number: 19660387
• Product Code: MIH
• UDI-Device Identifier: 00643169232631
• UDI-Public: 00643169232631
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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: 01/26/2018
• Device Model Number: ETUF3614C102E
• Device Catalogue Number: ETUF3614C102E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2021
• Initial Report FDA Received Date: 04/22/2021
• 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; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 145