MAUDE Adverse Event Report: Medtronic Ireland ENDURANT II AORTIC STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Catalog Number	ETCF2828C49E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	09/01/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during treatment of a 61 mm abdominal aortic aneurysm, a type 1a endoleak from a previously implanted non-medtronic product was treated with an endurant ii aortic cuff extension.There was 10 mm of proximal seal length between the right renal artery and the proximal edge of the previously implanted bifurcated graft.A 28 x 28 x 49 mm endurant ii aortic cuff extension was implanted.Guidewire was biased toward the left lateral aortic wall made exact visualization of the right lateral proximal graft position challenging.Completion  angiography identified partial coverage of the right renal artery, estimated at approximately 40%.The aortic extension landed in the intended position, and patient anatomy reportedly required partial right renal artery coverage to optimize the proximal seal zone.Intervention was required and a 7 mm renal stent was placed in the right renal artery to maintain patency.Completion angiography demonstrated patency of both renal arteries and no residual type 1a endoleak.Per the physician the cause of the occlusion was anatomy related and noted the patient¿s anatomy required partial coverage of right renal artery to optimize proximal seal zone.No additional clinical sequelae were reported and the patient is fine.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ENDURANT II AORTIC STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR
• Manufacturer (Section D): Medtronic Ireland; parkmore business park west; galway ; EI
• Manufacturer (Section G): Medtronic Ireland; parkmore business park west; galway ; EI
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; +353(091)708096
• MDR Report Key: 50588321
• Report Number: 9612164-2026-04417
• Device Sequence Number: 13119857
• Product Code: MIH
• UDI-Device Identifier: 00613994991447
• UDI-Public: (01)00613994991447(17)270818
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2026

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 Catalogue Number: ETCF2828C49E
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/04/2026
• Initial Report FDA Received Date: 09/03/2026
• Supplement Report FDA Received Date: 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male