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

Model Number	ETCF3232C49E
Medical Device Problem Codes	Leak/Splash (1354); Migration or Expulsion of Device (1395); Material Deformation (2976)
Health Effect - Clinical Codes	Pain (1994); Insufficient Information (4580)
Date of Event	03/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An aneurx stent graft system ( yrecxc22375,yrbrhxc2615135,ilxc161685 and ilxc1616115) was implanted for the treatment of an abdominal aortic aneurysm.Approximately 1 year and 10 months later two additional aneurx limb stent grafts (ilxc161685 and iexc202055) were implanted.The reason for implantation of these two limbs is not known.Two endurant ii stent graft cuffs were implanted to treat migrated and an endoleak of the aneurx stent graft eighteen years later.It was said the bifurcate stent graft had fallen into the aneurysm sac.The date when the migration and endoleak were first identified is unknown but it was said the patient had presented to the hospital symptomatic with pain.The physician was able to stabilize the patient with the implant of the endurant cuffs.Per the physician the first cuff was implanted and it appeared the proximal fixation was inverted.It was assumed that's why the second cuff was added but this was not confirmed.It was reported during a follow-up the patient was found to have a type iiia endoleak where the two endurant cuffs have disconnected.Per the physician the cause of the type iiia endoleak was not determined.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: e tcf3232c49e, serial/lot #: (b)(6), ubd: 31-may-2025, 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 EXTENSION CUFF
• 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: 21409776
• Report Number: 9612164-2025-00891
• Device Sequence Number: 9345569
• Product Code: MIH
• UDI-Device Identifier: 00613994991454
• UDI-Public: 00613994991454
• 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: 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
• Report Date (Section B): 02/19/2025

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: 10/30/2025
• Device Model Number: ETCF3232C49E
• Device Catalogue Number: ETCF3232C49E
• 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: 01/28/2025
• Initial Report FDA Received Date: 02/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2023
• 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: Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male