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

Model Number	ETBF2813C166E
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354); Migration or Expulsion of Device (1395); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Abdominal Pain (1685)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An etbf2813c166e stent graft was implanted during the endovascular treatment of an aaa.It was reported that 3 weeks later the patient presented to the emergency room with abdominal pain and the aaa measuring 90mm.A ct revealed that the supra-renal stent had detached from the main body of the endurant stent graft and the endurant stent graft had migrated into the abdominal aortic aneurysm sac.An attempted repair of the stent migration was performed using three non-mdt (gore 31x100 ctag) devices.A ia endoleak remained.Due to the persistent type 1a endoleak, a 32x32x49 endurant cuff was subsequently placed to address and successfully resolve the endoleak.Per the physician the cause of the event is undetermined.No additional clinical sequelae were provided and the patient is fine.
Additional Manufacturer Narrative
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
Product analysis conclusion: the reported suprarenal stent detachment and proximal endoleak were confirmed, and suprarenal stent fracture was identified on the reviewed images; however, the exact cause of the events could not be determined.Pre-implant cts were not available for evaluation of the pre-implant anatomy, and earlier post-implant cts were not available for assessment of stent graft configuration over time.The bifurcate had migrated distally due to suprarenal stent detachment, which likely resulted in a proximal type i endoleak.It is possible that disease progression due to neck dilatation over time contributed to the suprarenal stent detachment and the identified fracture.Aortic neck angulation during the duration of implantation may have also contributed to increased loading at the suprarenal stent attachment.Lack of proximal neck radial support caused by neck dilatation may have allowed increased loading of the graft fabr ic and/or sutures at the suprarenal stent-to-bifurcate fabric attachment, resulting in eventual failure of the graft fabric/sutures, fracture, and subsequent distal migration of the bifurcate.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
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 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: 23508740
• Report Number: 9612164-2025-05508
• Device Sequence Number: 8858142
• Product Code: MIH
• UDI-Device Identifier: 00613994991300
• UDI-Public: (01)00613994991300(17)200304
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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,Followup
• Report Date (Section B): 01/20/2026

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/04/2020
• Device Model Number: ETBF2813C166E
• Device Catalogue Number: ETBF2813C166E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 01/20/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 11/26/2025; 01/20/2026
• Date Device Manufactured: 03/05/2018
• 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: 72 YR
• Patient Sex: Male