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

Model Number	ETLW1616C124E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
B2.The exact date of death and event date (b3) is unknown.Year and month are valid.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: etlw1624c93e, serial/lot #: (b)(6), ubd: 02-jul-2026, udi#: (b)(4); product id: etlw1620c124e, serial/lot #: (b)(6), ubd: 27-jun-2026, 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
Three endurant stent grafts (etlw1616c124e, sn (b)(6); etlw1620c124e, serial # (b)(6) and etlw1624c93e, serial# (b)(6)) were implanted emergently to treat an aneurysm rupture due to a type iiia endoleak involving a previously implanted talent aaa stent graft system implanted 16 years prior.The patient also had an additional endurant ii limb implanted 3 years and 10 months prior to this intervention.The endurant limbs had to have been extended all the way up to flow divider of bifurcated talent graft to achieve a junctional seal followed by aggressive ballooning with a reliant balloon.An angiogram confirmed the resolution of the type iii endoleak.The patient continued to receive treatment after for complications related to the aneurysm rupture.It was reported the patient expired.Per the physician the cause of the type iii endoleak and subsequent rupture is undetermined.The cause and exact date of death was not provided.
Additional Manufacturer Narrative
B5: additional information received : it was reported that the patient¿s death was related to device-limb separation and the subsequent procedure to fix it.The patient died one day after the emergency procedure.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 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: 20514975
• Report Number: 9612164-2024-04853
• Device Sequence Number: 12901437
• Product Code: MIH
• UDI-Device Identifier: 00643169467675
• UDI-Public: 00643169467675
• 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: 2024
• 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): 10/25/2024

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: 08/31/2025
• Device Model Number: ETLW1616C124E
• Device Catalogue Number: ETLW1616C124E
• 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: 10/03/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 10/25/2024
• Date Device Manufactured: 09/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Outcome Attributed to Adverse Event: Death
• Patient Age: 80 YR
• Patient Sex: Male