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

Model Number	VNMF3731C173TU
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the valiant navion distal stent graft separated from the proximal valiant navion stent, and a type iii endoleak was present in the thoracic aorta.The event was discovered on the date of computed tomography.The patient was initially treated for a dissection measuring 200mm in length.Treatment involved re-lining the existing grafts with a 38-34/150 valiant captivia proximal graft and a 38-34/150 valiant captivia distal graft.The healthcare professional attributed the cause of the event to anatomical changes as the thoracic aorta bulged out on the outer curve, causing the distal graft to slide down and separate from the proximal graft.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
This is a system report.The section d information is for the primary device, which was in use with the following: brand name valiant navion; product id vnmc3434c90tu (serial: (b)(6); product type: 0180-aortic stent graft; implant date (b)(6) 2018; 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 NAVION
• 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: 21900289
• Report Number: 9612164-2025-02047
• Device Sequence Number: 8712965
• Product Code: MIH
• UDI-Device Identifier: 00763000100865
• UDI-Public: 00763000100865
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 04/24/2025

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/03/2020
• Device Model Number: VNMF3731C173TU
• Device Catalogue Number: VNMF3731C173TU
• 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: 04/23/2025
• Initial Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2018
• 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: 54 YR
• Patient Sex: Female