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

Catalog Number	ESBF3614C103E
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	02/20/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
An endurant iis stent graft system was implanted during the endovascular treatment of a 60mm aaa.It was reported that during the index procedure the physician deployed the contralateral limb without issue and then deployed on the ipsi-lateral side and pushed the delivery system of the bifurcate proximal.The physician began to pull the delivery system into the bifurcate.The sales representative attending the case advised the physician to stop due to the tip capture being open however the physician continued and said that it was closed.The physician continued to pull at the device despite it being caught and eventually pulled the bifurcate 50 mm into the aorta.The physician removed the device and in doing so caused a dissection in the common iliac artery.The physician then implanted two cuffs from the lowest renal into the bifurcate and repaired the right common iliac artery.Per the physician the cause of the event was user error.Once the delivery system was removed the rep looked at it on the back table and turned the back wheel closing the tip capture confirming it was open when being removed from the patient.No additional clinical sequelae was provided 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.

• 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 ; 091708096
• MDR Report Key: 21629795
• Report Number: 9612164-2025-01368
• Device Sequence Number: 18230209
• Product Code: MIH
• UDI-Device Identifier: 00643169439955
• UDI-Public: 00643169439955
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 03/18/2025

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: 12/19/2025
• Device Catalogue Number: ESBF3614C103E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2025
• Initial Report FDA Received Date: 03/18/2025
• Date Device Manufactured: 12/20/2023
• 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: 76 YR
• Patient Sex: Male