MAUDE Adverse Event Report: Medtronic Ireland ENDURANT IIS BIFURCATED STENT GRAFT; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Catalog Number	ESBF3614C103E
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2026
Type of Reportable Event	Malfunction
Event or Problem Description
An endurant iis stent graft (b)(6) was implanted during the endovascular treatment of a 58.5 mm abdominal aortic aneurysm.It was reported that during the index procedure, after visual inspection prior to use, the stent graft was delivered through the left common femoral artery to the implantation site.During deployment of the device, the physician applied gentle backward force pulling, rather than advancing, to keep the radiopaque markers aligned with the renal artery lines drawn on the screen.No resistance was felt by the physician.The device was delivered easily into position and implanted successfully.During removal of the delivery system, which was performed in accordance with the instructions for use (ifu), difficulty was encountered while attempting to remarry the delivery system , as the grey handle would not slide fully to the blue handle after advancing approximately halfway.Manual rotation of the blue handle was required to bring it into contact with the grey handle.Following removal, inspection identified a large twist or kink in the distal portion of the graft cover portion of the delivery device.The delivery device was successfully removed from the left groin, and the procedure was completed.Per the physician, the cause could not be determined; however, a tight aortic bifurcation was noted as a possible contributing anatomical factor.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis conclusion the reported difficulty in removing the delivery system and kink icould not be confirmed based on the pre-implant films provided; therefore, the cause of the event cannot be determined.Procedural angiograms showing stent graft deployment and removal attempts were not available for assessment.While the cause remains indeterminate, moderate calcification in the common iliac arteries may have been a contributing factor.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 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 ; +353(091)708096
• MDR Report Key: 50404789
• Report Number: 9612164-2026-04238
• Device Sequence Number: 13401841
• Product Code: MIH
• UDI-Device Identifier: 00643169439955
• UDI-Public: (01)00643169439955(17)280428
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P100021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 09/07/2026

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: ESBF3614C103E
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/07/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/03/2026
• Initial Report FDA Received Date: 08/24/2026
• Supplement Report FDA Received Date: 09/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2026
• 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: 76 YR
• Patient Sex: Male
• Patient Weight: 181 LB