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

Model Number	ESBF3614C103E
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/06/2025
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
An endurant iis bifurcate stent graft was implanted in the endovascular treatment of a 65mm aaa.  post-operatively,  a type ia endoleak was discovered on ct.The endoleak was attributable to in-folding in the body of the bifurcated graft, which was well-positioned at the renal arteries.The patient was treated non-emergently with two non mdt stents implanted to flatten the in-folding, which eliminated the endoleak. there were access issues with the closure devices, and a cutdown was performed on the right femoral artery to close the access site.  per the physician the cause of the infolding/ ia endoleak could not be determined.  no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Film analysis the reported stent graft infolding and endoleak were confirmed in the provided videos.However, the cause of the events could not be conclusively determined due to incomplete imaging data.The sizing report, which lacked still images, noted the infrarenal aortic neck diameter ranging from approximately 30-32 mm, from proximal to distal.It also noted the presence of moderate thrombus and mild calcification in the aortic neck.The pre-implant and post-implant ct images provided were in video format, which did not allow for image manipulation or alternative views, such as coronal or sagittal planes.These additional perspectives would have facilitated a more thorough evaluation of the infrarenal neck, including angulation, the infolding event, and the endoleak.Both videos ended at the level of the aneurysm sac, leaving the limbs unassessed in the pre and post-implant cts.Based on the available data, the endoleak appears most likely to be a type ia endoleak associated with the gutter formed by the infolding.The exact cause of the infolding remains undetermined.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: 22306224
• Report Number: 9612164-2025-03082
• Device Sequence Number: 15600034
• Product Code: MIH
• UDI-Device Identifier: 00643169439955
• UDI-Public: (01)00643169439955(17)261210(21)V31585683
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 08/16/2025

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: ESBF3614C103E
• Device Catalogue Number: ESBF3614C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2024
• 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 Sex: Male