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

Catalog Number	ETBF2513C145E
Medical Device Problem Codes	Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Rupture (2208)
Date of Event	02/21/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: etew2020c82e, serial/lot #: (b)(6), ubd: 14-oct-2015, udi#: (b)(4); product id: etlw1616c124e, serial/lot #: (b)(6), ubd: 16-dec-2015, udi#: (b)(4); product id: etlw1616c82e, serial/lot #: (b)(6), ubd: 28-aug-2015, udi#: (b)(4); product id: etlw1620c124e, serial/lot #: (b)(6), ubd: 16-sep-2015, udi#: (b)(4); product id: etlw1616c156e, serial/lot #: (b)(6), ubd: 22-aug-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.
Event or Problem Description
An endurant iis stent graft system was implanted during the endovascular treatment of a ruptured aaa.It was reported that the patient presented emergently 11 years post-index procedure with a ruptured aneurysm.The physician converted to open repair.The stent grafts were explanted and an aorta bifemoral bypass graft was implanted.The physician could not identify any possible leak source due to excessive bleeding but it was confirmed an endoleak was suspected to be the cause of the rupture.It was unclear the exact type but it was reported that a type ii endoleak was most likely.The patient passed away two days later.
Additional Manufacturer Narrative
The exact cause of the patient's death is not available.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 BIFURCATED STENT GRAFT
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• 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: 21629850
• Report Number: 9612164-2025-01369
• Device Sequence Number: 8925156
• Product Code: MIH
• UDI-Device Identifier: 00613994991232
• UDI-Public: 00613994991232
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2025
• 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): 03/25/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2015
• Device Catalogue Number: ETBF2513C145E
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 03/21/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 03/25/2025
• Date Device Manufactured: 05/07/2013
• 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.
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 76 KG