MAUDE Adverse Event Report: MEDTRONIC IRELAND VALIANT CAPTIVIA - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Catalog Number	VAMF3834C150TU
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Ischemia (1942); Muscle Weakness/Atrophy (1967); Paralysis (1997)
Date of Event	04/25/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: vamc3632c150tu, serial/lot#: (b)(6), ubd: 11-dec-2026, udi#: (b)(4); product id: vamc3430c150tu, serial/lot#: (b)(6), ubd: 03-jan-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.
Event or Problem Description
Three valiant captivia stent grafts were implanted during an initial staged endovascular procedure to treat a 70mm symptomatic thor acoabdominal aneurysm.A pre-operative computed tomography scan identified an occluded left subclavian artery and bilateral internal iliac occlusion, and the external iliac arteries were described as diseased and small; a high risk for paralysis was discussed prior to proceeding it was reported that during the index procedure a 10 mm non-medtronic stent was placed in the left external iliac artery and ballooned to 10 mm for graft placement, and the three valiant captivia stent grafts were placed from the level of the left carotid artery down to the celiac artery in the following order: vamf3834c150tu proximally, vamc3632c150tu middle graft and vamc3430c150tu distally.Visceral vessels were pre-stented for a planned second-stage procedure.The patient initially tolerated the procedure and then developed leg weakness with some partial paralysis one day post-operatively.The patient returned to the operating room for placement of a spinal drain and a carotid-subclavian bypass, and was reported to be gradually improving with some movement of the legs.It was noted that the carotid subclavian bypass was a planned procedure at the next stage since it was already occluded.The spinal drain was not part of the plan and was placed due to the ischemia.According to the physician, the cause of the event was anatomy involving occlusion of the subclavian artery and both internal iliac arteries.Post-operative complications were reported to be impacting the timing of the second-stage procedure.The patient will continue to be monitored.

• Brand Name: VALIANT CAPTIVIA - FF
• 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: 25157990
• Report Number: 9612164-2026-02468
• Device Sequence Number: 13147374
• Product Code: MIH
• UDI-Device Identifier: 00643169400160
• UDI-Public: (01)00643169400160(17)280107
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• 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
• Report Date (Section B): 05/13/2026

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: VAMF3834C150TU
• 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: 04/27/2026
• Initial Report FDA Received Date: 05/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: "SEE H11."
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male