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

Model Number	VAMF3430C150TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Pseudoaneurysm (2605)
Date of Event	06/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Three valiant captivia stent grafts (vamf3430c150tu, vamf3632c150tu and vamf3030c100tu) were implanted during the endovascular treatment of a taa.A follow-up ct scan performed approx.10 years post index procedure , revealed post-surgical changes of tevar.An outpouching from the endograft was observed within the aneurysm sac, measuring up to 80mm in diameter¿an increase from a previously measured 40mm in retrospect.This finding was concerning for a suspected pseudoaneurysm / type iii endoleak, and a type iiib endoleak was subsequently confirmed due to damage of the graft fabric.Additional findings included stable dilation of the aortic sinus (48 x 46 x 48 mm), stable dilation of the descending aorta up to 64mm, stable chronic dissection of the brachiocephalic artery extending to the origin of the right subclavian and common carotid arteries.There was also interval remodeling of chronic emboli in the left lower lobe without evidence of increased clot burden.A stable dissection and aneurysmal dilation of the infrarenal abdominal aorta (up to 34 mm) was noted, along with an unchanged chronic occlusion of the right axillary to bilateral femoral bypass graft.The stable chronic dissection of the brachiocephalic artery and in the abdominal aorta did not occur post the implant of the valiant captiva stent grafts.The valiant captivia did not cause or contribute to the dissections.The chronic occlusion of the right axillary to bilateral femoral bypass graft is unrelated to the tevar or the stent grafts the plan of care for the patient included continuing medications as prescribed, follow-up in 6 months with cta c/a/p, and discussion at a multidisciplinary vascular case conference to determine if another aortic repair is warranted and/or safe, with future treatment to be determined.No additional sequelae were reported, and the patient will be monitored.
Additional Manufacturer Narrative
Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: v amf3632c150tu, serial/lot #: (b)(6), ubd: 07-jan-2017, udi#: (b)(4) ; product id: vamf3030c100tu, serial/lot #: (b)(6), ubd: 22-jan-2017, 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: 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: 22466690
• Report Number: 9612164-2025-03383
• Device Sequence Number: 11786341
• Product Code: MIH
• UDI-Device Identifier: 00643169400146
• UDI-Public: (01)00643169400146(17)151212
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 07/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/12/2015
• Device Model Number: VAMF3430C150TU
• Device Catalogue Number: VAMF3430C150TU
• 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: 06/18/2025
• Initial Report FDA Received Date: 07/10/2025
• Date Device Manufactured: 12/12/2013
• 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...."
• Patient Age: 64 YR
• Patient Sex: Male