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

Model Number	ESBF2514C103E
Medical Device Problem Codes	Malposition of Device (2616); Material Deformation (2976)
Health Effect - Clinical Codes	Ischemia (1942); Obstruction/Occlusion (2422)
Date of Event	03/05/2025
Type of Reportable Event	Death
Event or Problem Description
An endurant iis bifurcate stent graft system was implanted in the endovascular treatment of bilateral common iliac aneurysms.During the index procedure the distal aorta was reinforced by using two 8- or 9-mm non-mdt balloons at the common and external iliac arteries after deploying the limb extensions.The physician also used two 9 mm non-mdt biliary stents and then used two non-mdt balloons to reinforce the distal aorta.This was done because the distal aorta was about 18mm in diameter.It was noted that gate deployment was crossed due to wires crossing.The right iliac extension on the right iliac did not deploy at max overlap (50 mm) and was deployed about 10 mm below the flow divider.It was reported that later that evening, intervention was performed as it was reported the limb had shut down.Both limbs were identical and it was not possible to identify which serial number is for the left vs right iliac.During the intervention, access was established and an angiogram was done.A narrowing of the contralateral gate could be visualized.Three non-mdt stents were implanted at the flow divider and into the bilateral iliac limbs.A final angiogram showed improvement.The following day the patient expired.Per the physician the cause of the deformation and subsequent death was anatomy.It was said the ima was occluded by the bifurcate graft.Both hypogastric arteries were severely diseased and almost occluded.The limb extensions were landed in the external iliac arteries.It is believed potential oversizing and potential ischemic issues could have contributed.
Additional Manufacturer Narrative
Film analysis review the reported deformation of the stent graft could not be fully appreciated on the images provided due to the quality of the images received.The images received did not allow for review of the occlusion of patient vessels.Post-implant ct's were not available for review and the stent graft in-vivo configuration could not be evaluated.The patient's anatomy at implant was noted as being narrowed in the distal aortic area at 18 mm and so it is likely that the patient's anatomy and the noted potential oversizing and ischemic issues contributed to the reported events.Analysis of the returned images did not reveal any obvious out of specification stent graft integrity issues.Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: etlw1610c146e, serial/lot #: (b)(6), ubd: 29-oct-2026, udi#: (b)(4); product id: etlw1610c146e, serial/lot #: (b)(6), ubd: 02-may-2026, udi#: (b)(4).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: 21686732
• Report Number: 9612164-2025-01520
• Device Sequence Number: 15636055
• Product Code: MIH
• UDI-Device Identifier: 00643169439986
• UDI-Public: 00643169439986
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2025

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: ESBF2514C103E
• Device Catalogue Number: ESBF2514C103E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2025
• Initial Report FDA Received Date: 03/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11...."
• Outcome Attributed to Adverse Event: Required Intervention; Death
• Patient Age: 75 YR
• Patient Sex: Male