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

Model Number	ETUF3614C102E
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/12/2025
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
It was reported that during the index procedure for treatment of a large abdominal aortic aneurysm (80.1mm x 58.5mm), a stent graft etuf3614c102e endur ii aui was placed in a patient with a history of aorta-by-fem bypass and right to left fem-fem bypass.A pseudoaneurysm was present at the proximal anastomosis prior to the procedure.The distal portion of the graft was positioned in the most proximal anastomosis of the aorta-by-fem, where the tip capture mechanism became stuck during attempted retrieval and remaking of the device.The graft cover was damaged during these attempts, causing further issues at both the proximal and distal anastomoses.An open surgical cutdown to the proximal anastomosis and bypass graft was performed, and internal physical manipulation was attempted to free the tip capture, but this was unsuccessful.A subsequent cutdown onto the bypass graft allowed the tip capture to be released.Upon further attempts to remake the device, it was discovered that the graft cover was damaged and would not allow full recapture of the tip.The device was then pulled through the bypass, becoming stuck at the distal anastomosis, necessitating an additional groin access cutdown to facilitate removal.An 8mm x 79mm non-medtronic stent ( vbx) was then placed through the distal portion of the aui graft down to the fem-fem bypass.The cause of the event was attributed to the anatomy, specifically the placement of the distal portion of the graft in the proximal aorta-by-fem anastomosis.The event was resolved by dislodging the tip capture with a combination of open and percutaneous techniques.
Additional Manufacturer Narrative
Product analysis conclusions: the reported 'difficulty to remove' was confirmed on the films; however, the cause of the event could not be conclusively determined based on the images available.Pre-implant ct scans were not available for evaluation of the pre-implant anatomy, and additional procedural images were not provided for a more comprehensive assessment of the event.The reported deformation of the graft cover could not be confirmed based on the images provided.Image depicts the distal section of an endurant delivery system.The graft has been deployed.The tip appears to have been recaptured, but deformation is evident to the graft cover.Product analysis #(b)(4): device returned in a biohazard within an outer bag lot on device wouldn't scan.Lot number on pro forma match lot on gch.Size of device matches b5; additional information received: it was confirmed there were no issues noted with the device during preparation or insertion into the patient.The device was used per ifu.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
Device analysis conclusion: device received with the external slider and backend wheel in the home position.Deformation was evident along the graft cover proximal and distal to the stent stop.A gap was evident between the graft cover and tip with the tip capture mechanism partially exposed.Deformation was evident to the distal edge of the graft cover.Separation was evident to the spiral member immediately proximal to the tip capture mechanism.The graft cover advanced and retracted with no issues noted.The tip capture mechanism retracted with significant biological material evident.The biological material was removed, and the tip capture mechanism retracted and advanced via rotation of the backend wheel with no issues noted.No other deformation evident to the remainder of the device.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 AUI 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: 22273949
• Report Number: 9612164-2025-02992
• Device Sequence Number: 3797055
• Product Code: MIH
• UDI-Device Identifier: 00643169232631
• UDI-Public: (01)00643169232631(17)250704(21)V31197244
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 08/08/2025

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: 07/04/2025
• Device Model Number: ETUF3614C102E
• Device Catalogue Number: ETUF3614C102E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 06/18/2025; 07/25/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/10/2025; 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2023
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 59 KG