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

Catalog Number	ETBF2813C145E
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Rupture (2208); Obstruction/Occlusion (2422)
Date of Event	05/11/2026
Type of Reportable Event	Death
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.
Event or Problem Description
An endurant ii stent graft system was implanted during the endovascular treatment of a 50 mm aneurysm.It was reported that the patient presented emergently 9.5 years later with a ruptured aneurysm.It was noted that the patient had a fall at their home 3 days before.Total occlusion of the right iliac limb, noted as the ipsilateral limb of the bifurcate was also identified on the ct scan.An endoleak was identified and was suspected to be a type iii fabric endoleak.A 28 aui stent graft was then implanted via the left side but the endoleak was still present.The physician attempted to access the right limb by cutting down on the common femoral but were unable to pass a wire up the limb so no they could not perform any treatment to restore flow.The pre-operative cta performed showed the right limb totally occluded , however, there was some flow into the right limb observed during the procedural angiogram.It was reported that the patient expired on the same day.According to the physician, the cause of death was attributed to the type iii endoleak following trauma.

• Brand Name: ENDURANT II BIFURCATED 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 ; 091708096
• MDR Report Key: 25268466
• Report Number: 9612164-2026-02678
• Device Sequence Number: 13187627
• Product Code: MIH
• UDI-Device Identifier: 00613994991294
• UDI-Public: (01)00613994991294(17)180913
• 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: 2017
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/13/2018
• Device Catalogue Number: ETBF2813C145E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 05/25/2026
• Date Device Manufactured: 09/13/2016
• 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; Death
• Patient Age: 78 YR
• Patient Sex: Female