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

Catalog Number	ETCF3636C49E
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an endovascular aortic repair for a 67 mm abdominal aortic aneurysm, using the stent graft etcf3636c49e endur ii aoext, after deployment,  a non medtronic guide wire was pulled back unintentionally and unnoticed by the physician and buckled at the tip of the delivery system.The physician didnt feel comfortable trying to advance such a stiff wire back into the aorta in that position and decided to remove this wire and replace it with a less still wire.  the wire wouldn't advance through the distal tip of the delivery system.It was felt like it was hitting up against something bending the wire up.The physician tried multiple different stiffness of wires and the same issue occurred.The physician tried to use a wire cheater but nothing would help the wire pass through the port.The tip of any wires wouldn¿t pass at about 1 inch into the back end of the delivery system and every wire would come out curled up and damaged. eventually the physician tried the back end of a non medtronic wire and it went through but the physician didn't want that to be in the aorta due to its length and it being the back end.Eventually after spinning the back end super renal blue wheel a medtronic steerant wire was able to be advanced and the delivery system removed successfully.Per the physician the cause of the event could not be determined.No additional clinical sequalae were provided and the patient is fine.
Additional Manufacturer Narrative
Product analysis: the stent graft had been deployed prior to receipt of the device and was not received alongside.Torsional deformation was evident to the graft cover.An in-house 0.035¿ guidewire was backloaded through the tip and advanced with no issues noted.Analysis of the device found no evidence of a blockage.No other deformation evident to the remainder of the device.Product analysis conclusion: the reported blockage of the delivery system could not be confirmed based on the pre-implant imaging provided; therefore, the cause of the event could not be determined.Procedural angiogram videos demonstrating attempts to advance multiple wires within the delivery system were not available for review.No obvious anatomical findings on pre-implant imaging were identified that would be likely to contribute to this issue.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: 23494421
• Report Number: 9612164-2025-05475
• Device Sequence Number: 9106540
• Product Code: MIH
• UDI-Device Identifier: 00613994991461
• UDI-Public: (01)00613994991461(17)270227
• 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
• Report Date (Section B): 11/07/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ETCF3636C49E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2025
• Initial Report FDA Received Date: 11/07/2025
• Date Device Manufactured: 02/27/2025
• 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
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 76 KG