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

Catalog Number	ETLW1616C124E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Local Reaction (2035); Unspecified Gastrointestinal Problem (4491)
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant iis stent graft system was implanted during an unknown endovascular procedure.The patient made contact through technical services and reported a possible allergic reaction described as gi symptoms.Technical services therefore provided information on the stent graft materials.Two days later, another caller again requested the materials of the stent graft and reported a potential reaction.Further information was attempted to be provided but was declined as it was stated the information was already received.Another call was received to report the patient had pains in his abdomen and lost weight and was found by allegists to have a previously unknown nickel allergy.Pet scans showed inflammation in the stomach.The caller requested a sample of the stent which it was explained we do not provide and although the materials of the stent graft were provided actual percentages couldn't be provided.The physician confirmed that there is no record of complaints of infection or issues regarding the endurant device for this patient.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: e sbf2814c103e, serial/lot #: (b)(6), ubd: 05-nov-2021, udi#: (b)(4); product id: etlw1613c124e, serial/lot #: (b)(6), ubd: 16-nov-2022, 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.

• Brand Name: ENDURANT II ILIAC 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: 23001875
• Report Number: 9612164-2025-04437
• Device Sequence Number: 18546656
• Product Code: MIH
• UDI-Device Identifier: 00643169467675
• UDI-Public: (01)00643169467675(17)221030
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/09/2025

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: 10/30/2022
• Device Catalogue Number: ETLW1616C124E
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Initial Report FDA Received Date: 09/09/2025
• Date Device Manufactured: 10/30/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Patient Age: 70 YR
• Patient Sex: Male