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

Catalog Number	ESBF2814C103E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sepsis (2067); Septic Shock (2068)
Date of Event	09/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant iis stent graft system was implanted during an unknown endovascular procedure.It was reported via technical services that approximately 2 years and 4 months post-index procedure, the patient has experienced four episodes of sepsis due to pseudomonas aeruginosa, which were alleged to have been caused by the medtronic stent grafts.The patient also experienced toxic shock.The patient is currently being treated with antibiotics and is stable.No additional clinical sequelae were reported, and the patient will be monitored.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: etlw1616c124e, serial/lot #: (b)(6), ubd: 11-sep-2024, udi#: (b)(4); product id: etlw1620c124e, serial/lot #: (b)(6), ubd: 26-sep-2024, udi#: (b)(4).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.
Additional Manufacturer Narrative
Additional information received; the physician has not seen the patient since april 2025, at which point there were no issues reported.They have no knowledge of the sepsis event and have not been contacted with regard to it.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 IIS 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: 24577501
• Report Number: 9612164-2026-01281
• Device Sequence Number: 10334898
• Product Code: MIH
• UDI-Device Identifier: 00643169439979
• UDI-Public: (01)00643169439979(17)250202
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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 Expiration Date: 02/02/2025
• Device Catalogue Number: ESBF2814C103E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/12/2026
• Supplement Report FDA Received Date: 04/09/2026
• Date Device Manufactured: 02/03/2023
• 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: Other
• Patient Age: 82 YR
• Patient Sex: Male