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

Catalog Number	ETCF3636C49E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422); Unspecified Kidney or Urinary Problem (4503)
Date of Event	07/09/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant iis stent graft system and endurant cuff etcf3636c49e were implanted during the endovascular treatment of a 37mm x 42mm abdominal aortic aneurysm with pau.Left hypogastric embolization due to lt common iliac aneurysm was also performed.It was reported during the index procedure, the main body was landed low due to conical neck and etcf3636c49e, was used to cuff up to the renal with no difficulty and the procedure completed.It was reported on the one month follow up it was identified that the left renal had been covered but still with flow into it.Review of cta showed that it appeared the ostium of the left renal was occluded but had flow distal to the occlusion.Intervention was completed (b)(6) 2026) with the implant of a renal stent.Post the intervention the physician reported that the during the intervention procedure technically everything went fine putting stent in the left renal, but later the patient had some hypotension and some other renal issues.The patient is currently being monitored in icu.Per the physician the cause was anatomy related due to conical infrarenal neck.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: ENDURANT II EXTENSION CUFF
• 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: 50032301
• Report Number: 9612164-2026-03738
• Device Sequence Number: 15929724
• Product Code: MIH
• UDI-Device Identifier: 00613994991461
• UDI-Public: (01)00613994991461(17)271104
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/04/2026

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: ETCF3636C49E
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/22/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Supplement Date Received by Manufacturer: 07/27/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 08/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2025
• 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: 62 YR
• Patient Sex: Male