Valiant Navion™ VNMF4343C223TU (UDI 00763000100773)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000100773), received between Jul 15, 2022 and Apr 1, 2025 — classified as 1 death, 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 1, 2025Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING FROM APPROX. 48 MONTHS POST INDEX PROCEDURE, NOTED A NEW STENT RING ENLARGEMENT OF + 1.5MM WAS NOTED ON RING 4 OF (B)(6) AND +1.6MM ON RING 6 OF (B)(6). A NEW TYPE IIIB ENDOLEAK OBSERVED ON STENT GRAFT (B)(6). NO FRACTURE OR STENT RING MIGRATION WERE NOTED. THE MAXIMUM AORTIC DIAMETER MEASURED 58.5MM. NO AORTIC ENLARGEMENT WAS REPORTED. NO STENT RING MIGRATION OR STENT FRACTURES WERE OBSERVED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm expansion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 21738586 ↗
• MalfunctionFeb 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  TWO VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TYPE B AORTIC DISSECTION. THE PATIENT ALSO HAD A VALIANT CAPTIVIA AND NON MDT GRAFT IMPLANTED 2 YEARS POST THE INDEX PROCEDURE. IT WAS REPORTED CORE LAB REVIEW CT IMAGING FROM APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE SHOWED NEW STENT RING ENLARGEMENT OF +1.6MM, ON RING 3 OF VNMF4343C223TU. NO ENDOLEAK, STENT FRACTURE OR STENT RING MIGRATION WAS OBSERVED. THE MAX AORTIC DIAMETER WAS NOTED AS 53.5MM. NO AORTIC ENLARGEMENT WAS OBSERVED. THE CAUSE OF THE STENT RING ENLARGEMENT IS UNDETERMINED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18675430 ↗
• DeathJul 15, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 100MM THORACIC AORTIC ANEURYSM. ANOTHER VALIANT NAVION STENT GRAFT WAS IMPLANTED THE NEXT DAY. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE WITH A THORACIC RUPTURE. THE PHYSICIAN STATED THE CT SHOWED A POSSIBLE TYPE III ENDOLEAK. THE PATIENT EXPIRED ON THE SAME DAY. AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS AS A RESULT OF THE THORACIC RUPTURE. NO CAUSE OF THE ENDOLEAK HAS BEEN REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Rupture

  MAUDE report 15026139 ↗