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

Catalog Number	ETLW1613C124EE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	03/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an endovascular aortic repair with leia coiling for a 70 mm abdominal aortic aneurysm.The patient presented with hypertension, an angulated aortic neck (85 degrees) with bilateral common iliac aneurysm and a renal accessory artery on the right side a right renal accessory artery, intraluminal thrombus inside the abdominal aortic aneurysm sac and both common iliacaneurysms, and tortuous iliac arteries.During the procedure, a vascular plug was deployed on the left side, followed by implantation from the left side of the stent graft etbf2516c166e.E endur ii bif with side-by-side limb configuration.Multiple failed attempts at contralateral cannulation from right femoral access occurred, necessitating axial cannulation and snaring.During cannulation, the ipsilateral limb had not yet been fully deployed.After successful guidewire passage through the contralateral limb, the ipsilateral limb was fully deployed.The contralateral leg was extended with a device targeting the mid right common iliac artery for distal sealing, and the ipsilateral leg was extended to the left external iliac artery.Prior to angiography, the left external iliac artery was noted to have an accordion-like appearance.Balloon molding was performed on the proximal segment, overlapping graft, and both distal grafts.Aortography revealed no flow to both iliac arteries and a suspected thrombus inside the stents etlw1620c124ee & etlw1613c124ee with the thrombus extending to the main body.Thrombectomy was performed with several cycles on both sides.Final aortography showed restored contrast flow to both sides, with slow flow in the left iliac artery.The patient was transferred to the intensive care unit for observation and was reported to be alive and stable, extubated, and under observation post-procedure the cause was attributed to anatomy and turbulence flow from the tortuosity of the iliac arteries.
Additional Manufacturer Narrative
Film analysis conclusion : the reported stent graft occlusion was confirmed on review of the films provided.While the precise cause of the event cannot be definitively determined, anatomical factors , including tortuous iliac anatomy and the identified pre-operative vessel thrombus most likely contributed to the event.Other potential contributory factor, such as extension of the ipsilateral limb into the external iliac artery ,may have also played a role.The occlusive event may be also have been exacerbated by other conditions, e.G.An unknown coagulopathy that is now presenting, or a previous history of pad.Analysis of the returned films 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: e tlw1620c124ee, serial/lot#: (b)(6), ubd: 12-nov-2027, 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 II ILIAC 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: 24738732
• Report Number: 9612164-2026-01632
• Device Sequence Number: 17466401
• Product Code: MIH
• UDI-Device Identifier: 00763000574949
• UDI-Public: (01)00763000574949(17)270923(20)01
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ETLW1613C124EE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 03/31/2026
• Date Device Manufactured: 09/23/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male