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

Model Number	ESBF3214C103E
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a computed tomography revealed a type ia endoleak due to a proximal infolding associated with the stent graft e sbf3214c103e endur iis bif.The patient was treated for an 57mm abdominal aortic aneurysm.Intervention was performed 17 days later where a non-medtronic stent was implanted and fixed the infolding.Per the physician, there was stent graft oversizing that could have caused the infolding.No additional sequelae were reported 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 stent graft infolding and type ia endoleak were confirmed on the provided imaging; however, the cause of these events could not be fully determined.Lack of pre-implant cts did not allow for assessment of the pre-implant anatomy and evaluation of the infrarenal neck for potential oversizing.The type ia endoleak is most likely associated with the observed infolding.Lumbar arteries being patent and the presence of a concomitant type ii endoleak cannot be ruled out.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
Film analysis summary additional imaging, including pre-implant cts (with a sizing report) and post-implant cts after the intervention procedure, were received for review.Based on a previously completed review of post-implant cts taken approximately 1 month post-index procedure, the proximal stent graft margin was placed just distal to the main left renal artery.Film analysis of the pre-implant cts revealed a mildly calcified proximal aortic neck with a minimum diameter of approximately 23-24mm just distal to the main left renal artery, indicating that stent graft oversizing was likely a contributing factor to the infolding.There was some discrepancy observed between the measurements taken during the review of the pre-implant cts when compared to the measurements provided in the pre-implant report.It appears that the report measurements regarding the aortic neck could have been taken from distal to the left accessory renal artery and not from the main left renal artery, which explain the difference.Instructions for use for the endurant iis stent graft advise that the aortic section of the bifurcated stent graft should be oversized 10-20% in relation to the actual measured inner vessel diameter.This measurement should take into account thrombus and calcification present within the vessel, as these have the capacity to decrease the inner vessel diameter.The images received after the intervention procedure to treat the infolding and type ia endoleak showed that both events have resolved after the implantation of a non-medtronic stent within the endurant iis main body stent graft.Lumbar arteries remained patent, and there was no obvious contrast leakage in the aneurysm sac.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 IIS 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: 21916629
• Report Number: 9612164-2025-02075
• Device Sequence Number: 8669400
• Product Code: MIH
• UDI-Device Identifier: 00643169439962
• UDI-Public: (01)00643169439962(17)261104(21)V31552728
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted 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,Followup
• Report Date (Section B): 07/29/2025

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 Model Number: ESBF3214C103E
• Device Catalogue Number: ESBF3214C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 06/13/2025; 07/15/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 07/04/2025; 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2024
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 115 KG