MAUDE Adverse Event Report: Medtronic Ireland Valiant Captivia - FF; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TR

Catalog Number	VAMF3838C150TU
Medical Device Problem Codes	Leak/Splash (1354); Device Damaged by Another Device (2915)
Health Effect - Clinical Codes	Stroke/CVA (1770); Paresis (1998)
Date of Event	07/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
A modified valiant captivia stent graft vamf3838c150tu was implanted during the endovascular treatment of 69mm ascending thoracic aortic aneurysm in the ascending aorta.Pt disease was a focal pau starting in the distal aspect of zone 2.The physician unsheathed the vamf3838c150tu on the back table and modified the graft according to the "double fenestrated valiant captivia" published literature creating a large fenestration "window", 25mm distal to the graft edge and then creating an 8mm wire tipped reinforced fenestration 5mm distal to the large proximal fenestration.A 260cm glide wire was used after an 18gauage angiocath puncture of the delivery sheath to provide a "pre-cannulated wire for the lsa.The graft stent struts were systematically reconstrained with silk ties and the graft was resheathed, releasing silk ties appropriately.As planned- the pre-cannulated wire exited the tip of the device, above the graft from the lsa to edge, but "within" the graft delivery sheath.Moderate calcification of the aortic bifurcation as well as the bilateral cia in the proximal 20mm, mild/moderate tortuosity of the cia from the mid-proximal segment.It was reported during the index procedure, a pre-cannulated wire was snared and pulled to left brachial access to create a through -and-through wire from distal right femoral artery access.The graft was delivered without a sheath and advanced over a non medtronic wire, and rotational movements were performed in the descending thoracic aorta due to concern that the through-and-through wire could be wrapped around the delivery system.The delivery system was advanced into the arch and partial ascending aorta, angiography was performed, and graft modifications were aligned with the supra-aortic trunk vessels.During normal graft deployment, the deploying graft pinned the through-and-through wire against the aortic wall in contact with one of the modified graft segments.The graft was fully deployed, then recaptured and removed per the instructions for use, and a 20fr non medtronic sheath was inserted into the right femoral access site.Attempts to free the pinned wire using catheters and percutaneous transluminal angioplasty balloons were unsuccessful, and the physician decided to stent through the lsa fenestration to the proximal segment of the lsa creating a conduit for perfusion from the fenestration, to the vessel.Angiography identified a mild type ia endoleak with perfusion to all three supra aortic vessels (the brachiocephalic trunk, left common carotid artery, and left subclavian artery).The procedure was then completed.Approximately 3 hours after the end of the procedure, the patient was unable to move the right-sided extremities and was found on examination and testing to be positive for a cerebrovascular accident with right-sided hemiplegia.On post op day 4 the physician described the patient as ¿gaining motion¿ on the affected l side and the patient was released from the facility the cause of the event could not be determined.The physician confirmed that there is no current plan to treat the present ia and described that due to the procedural challenges and patient course- no immediate procedure could be justified.The patient was reported alive with injury and will be monitored.
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: 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 ; +353(091)708096
• MDR Report Key: 50083887
• Report Number: 9612164-2026-03847
• Device Sequence Number: 10719519
• Product Code: MIH
• UDI-Device Identifier: 00643169346956
• UDI-Public: (01)00643169346956(17)280409
• 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): 07/30/2026

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: VAMF3838C150TU
• 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: 07/21/2026
• Initial Report FDA Received Date: 07/30/2026
• Date Device Manufactured: 04/10/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 187 LB