Valiant Navion™ VNMF4343C103TU (UDI 00763000260545)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000260545), received between Nov 11, 2022 and Nov 11, 2022 — classified as 1 death.

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

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.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathNov 11, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION (V08147847) STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TYPE IA ENDOLEAK AS A ENDOGRAFT EXTENSION WITH BILATERAL RENAL ARTERY AND SMA SNORKELING. A ENDURANT II STENT GRAFT SYSTEM HAD BEEN IMPLANTED 3 YEARS AND 5 MONTHS PREVIOUSLY. ABOUT 5 MONTHS POST THE NAVION IMPLANT, THE PATIENT WAS STRUGGLING WITH VARIOUS ENDOLEAKS AND COIL EMBOLIZATION AND GLUE WAS USED AS TREATMENT. 4 MONTHS LATER, AN AORTIC ENDOLEAK REQUIRED INTERVENTION WITH ONYX GLUE. ANOTHER 8 MONTHS LATER, THE PATIENT HAS A TAAA THAT IS AT AN OPERABLE SIZE. THE PATIENT UNDERWENT AN OPEN REPAIR, A NON MDT BRANCH GRAFT WAS PLACED WHILE THE VALIANT NAVION V08147847 WAS EXPLANTED. ANOTHER 6 MONTHS LATER, A NEW THORACIC AORTIC ANEURYSM AND THORACOABDOMINAL AORTIC DISSECTION WERE OBSERVED SO 6 VALIANT NAVIONS WERE IMPLANTED. A CT SCAN WAS PERFORMED JUST OVER 3 MONTHS POST THE 6 VALIANT NAVION IMPLANTS. A CT OF THE CHEST DEMONSTRATES THE DIMENSIONS OF THE THORACIC AORTIC ANEURYSM IN THE APPEARANCE OF THE ENDOGRAFT REPAIR ARE STABLE. THE NATIVE ANEURYSM MEASURES UP TO 6.3 CM AXIALLY IN THE DESCENDING AORTA. THE DENSITY OF THE CLOT IN THE ANEURYSM OF THE DESCENDING THORACIC AORTA IS DIMINISHED FR

  Patient problems: Insufficient Information; Pleural Effusion

  MAUDE report 15779964 ↗