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

Catalog Number	VAMF2626C100TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Fistula (1862)
Date of Event	06/15/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A valiant captivia stent grafts was implanted during the treatment of a penetrating aortic ulcer (pau) procedure.Per the operative notes, the patient was known to have a infected aorta at the time and before implanting the graft, the surgeon soaked the stent graft in an antibiotic called revampin.The patient was lost to follow and was not taking antibiotics to get rid of the infection.  approximately 46 months post index procedure, a ct noted an aorto-eosophageal fistula (aef) and an intercostal type ii endoleak.Re -lining was performed on the same date using a new valiant captivia device due to the need for an eosophagectomy for the aef.Prior to the re-lining procedure, the new graft was soaked in an antibiotic also before implanting.Per the physician the source or cause of the infection is unknown.Per the physician, the aef was associated with the tevar procedure/device.
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 ; 091708096
• MDR Report Key: 22435069
• Report Number: 9612164-2025-03341
• Device Sequence Number: 3152513
• Product Code: MIH
• UDI-Device Identifier: 00643169347106
• UDI-Public: (01)00643169347106(17)230217
• 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: 2021
• 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): 07/08/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/17/2023
• Device Catalogue Number: VAMF2626C100TU
• 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: 06/15/2025
• Initial Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2021
• 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: 71 YR
• Patient Sex: Female