Valiant Navion™ VNMF4343C62TU (UDI 00763000100742)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000100742), received between Oct 3, 2023 and Oct 21, 2024 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Feb 12, 2021Class IOpen, Classified

   Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.

   Z-1201-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 21, 2024Leak/Splash; Leak/Splash

  THREE VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR TREATMENT OF A TAA. IT WAS REPORTED THAT CT TAKEN AT 40 MONTHS POST INDEX PROCEDURE DEMONSTRATED AORTIC ENLARGEMENT. THE ANEURYSM DIAMETER MEASURED 69 X 85MM COMPARED TO PRIOR MEASUREMENT OF 69 X 69MM. CT FROM 41 MONTHS POS-INDEX PROCEDURE SHOWED INTERVAL ENLARGEMENT OF THE ANEURYSM SAC; NO DISCRETE ENDOLEAK IDENTIFIED, RAISING CONCERN FOR OCCULT ENDOLEAK. VASCULAR NOTES FROM 42 MONTHS POST-INDEX STATED THAT AORTIC ENLARGEMENT OCCURRED AND THE ANEURYSM DIAMETER MEASURED 89MM. A TYPE I ENDOLEAK WAS SUSPECTED FROM THE PROXIMAL NECK DUE TO TORTUOSITY OR FROM DISTAL TO PREVIOUS TUBE GRAFT ONLY. ANGIO FROM ONE DAY EARLIER IDENTIFIED A TYPE I ENDOLEAK ALONG PROXIMAL RIGHT ASPECT OF THE GRAFT; NO EVIDENCE OF TYPE II ENDOLEAK. 43 MONTHS POST-INDEX MULTIPLE ABDOMINAL AORTOGRAMS IDENTIFIED TYPE I ENDOLEAK PROXIMAL END OF GRAFT, UNABLE TO DETERMINE IF TYPE IA OR IB. DID NOT FULLY IDENTIFY FILLING OF THE ANEURYSM SAC. DID VISUALIZE LUMBAR AND MESENTERIC BRANCHES APPEARED TO BACK FLOW TOWARDS THE ANEURYSM SAC. 44 MONTHS POST-INDEX CONTRAST CT IDENTIFIED A FUSIFORM INFRARENAL AAA MEASURING 8.6X2.5CM IN CROSS SECTION. NO VISI

  Patient problems: Aneurysm

  MAUDE report 20491928 ↗
• DeathOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT CORELAB REVIEW OF CT IMAGING DATED APPROXIMATELY 12 YEARS POST THE INDEX PROCEDURE SHOWED AORTIC ENLARGEMENT OF +15.2MM AND A MAXIMUM AORTIC DIAMETER OF 73.1MM AND CT IMAGING DATED (B)(6) 2022 SHOWED AORTIC ENLARGEMENT OF +11.8MM AND A MAXIMUM AORTIC DIAMETER OF 69.7MM. THE CTS WERE COMPARED TO IMAGING DATED (B)(6) 2020. ALL OF THE IMAGING WAS NON-EVALUABLE FOR FRACTURE, STENT RING ENLARGEMENT AND STENT RING MIGRATION. NO ENDOLEAKS WERE OBSERVED. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED. NO INFORMATION OF THE CAUSE OR DATE OF DEATH HAS BEEN PROVIDED.

  Patient problems: Aneurysm

  MAUDE report 17859542 ↗