Valiant Navion™ VNMC4034C200TU (UDI 00763000261047)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000261047), received between Oct 14, 2020 and Aug 4, 2022 — classified as 1 death, 1 malfunction.

The most frequently reported specific device problem is “Material Deformation” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 4, 2022Material Deformation; Material Deformation

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A  UNKNOWN SIZED THORACIC AORTIC ANEURYSM ON (B)(6) 2020.  IT WAS REPORTED THAT CORELAB REVIEWED A CT DATED (B)(6) 2022. STENT RING ENLARGEMENT OF + 1.6 WAS IDENTIFIED. NO ENDOLEAK OR FRACTURE WAS NOTED.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15164028 ↗
• DeathOct 14, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION. THE DISSECTION MEASURED FROM THE LSA TO ILIAC BIFURCATIONS. IT WAS REPORTED APPROXIMATELY 4 MONTHS POST THE INDEX PROCEDURE, FOLLOW UP CT DEMONSTRATED THAT THE GRAFT WAS DISTAL TO THE LCCA AND HAD A TYPE IA ENDOLEAK. DURING THE INITIAL PROCEDURE THE GRAFT APPEARED TO BE 5MM DISTAL TO THE LCCA AND THE FINAL ANGIOGRAM CONFIRMED SEAL AND THE DECISION WAS MADE NOT TO EXTEND AT THAT TIME HOWEVER NOW THE GRAFT APPEARS TO HAVE MIGRATED DISTAL LEADING TO A TYPE IA ENDOLEAK. THE PATIENT UNDERWENT AORTIC ARCH DEBRANCHING AND ENDOGRAFT PLACEMENT FROM THE ASCENDING AORTA INTO THE EXISTING DESCENDING THORACIC GRAFT. VNMC4034C200TU (B)(4) WAS USED. IT WAS THEN REPORTED ONE DAY LATER THE PATIENT STARTED BLEEDING OUT OF THE MEDIASTINAL TUBE. THE PATIENT WAS RUSHED TO THE OPERATING ROOM AND OPENED WHERE IT WAS NOTED THAT THE PROXIMAL END OF THE GRAFT HAD PERFORATED THE AORTA. MULTIPLE REPAIR STITCHES WERE PLACED BUT WOULD NOT HOLD IN THE FRAGILE AORTA AND THE PATIENT CONTINUED TO SUFFER BLOOD LOSS AND EXPIRED. PER THE PHYSICIAN THE CAUSE OF THE MIGRATION WAS USER ERROR.

  Patient problems: Blood Loss; Death; Perforation

  MAUDE report 10676705 ↗