Valiant Navion™ VNMF4034C185TU (UDI 00763000100872)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000100872), received between May 23, 2022 and Apr 19, 2024 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2024Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT (VNMF4034C185TU) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. THE PATIENT HAD AN EXISTING VALIANT CAPTIVIA (VAMF4040C150TU) THORACIC STENT GRAFT IMPLANTED 6 YEARS PREVIOULSY. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING TAKEN APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE SHOWED A TYPE IA (NEW) ENDOLEAK. THE MAX AORTIC DIAMETER WAS NOTED AS 89.1MM. THE IMAGING WAS NA FOR AORTIC ENLARGEMENT. NO STENT FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED. A REINTERVENTION WAS PERFORMED. THE CAUSE OF THE TYPE IA ENDOLEAK IS UNDETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 19141811 ↗
• DeathJul 17, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 70MM TAA.  IT WAS REPORTED ONE DAY POST THE INDEX PROCEDURE, CT SHOWED THE FOLLOWING OBSERVATIONS: INTERNAL DEVELOPMENT OF A SHORT SEGMENT TYPE B DISSECTION / TYPE I ENDOLEAK ALONG PROXIMAL ORIGIN OF STENT. A 2.4X2.9 CM HEMATOMA MEDIAL TO THE LEFT DISTAL EXTERNAL ILIAC ARTERY AND A OCCLUSION OF THE ANTERIOR DIVISION OF THE LEFT MAIN RENAL ARTERY. IT IS UNKNOWN WHICH STENT GRAFT THE ENDOLEAK OCCURRED.  THE PATIENT SUBSEQUENTLY EXPIRED APPROXIMATELY 1 MONTH POST THE INDEX PROCEDURE DUE TO PNEUMONIA. IT IS UNKNOWN WHEN THE PATIENT DEVELOPED THE PNEUMONIA. PER THE PHYSICIAN THE CAUSE OF THE EVENTS SEEN ON THE CT COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT EXPIRED.

  Patient problems: Hematoma; Obstruction/Occlusion; Pneumonia; Vascular Dissection

  MAUDE report 17331324 ↗
• MalfunctionJun 30, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA AND DISSECTION .  IT WAS REPORTED CT IMAGING WAS PERFORMED ABOUT THREE AND HALF YEARS LATER . CORELAB HAVE REVIEWED THIS IMAGING AND IDENTIFIED AN UND ETERMINED TYPE ENDOLEAK.  A FRACTURE WAS NOTED ON THE STENT GRAFT WITH SN (B)(6). STENT RING ENLARGEMENT WAS ALSO NOTED ON STENT GRAFT WITH (B)(6) , STENT RING 4 (+ 4.2) , STENT RING 5 (+7.3), STENT RING 6 (+7.1). NO STENT RING MIGRATION WAS NOTED. THE MAXIMUM AORTIC DIAMETER MEASURED 71.9MM.  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 17237617 ↗
• MalfunctionMay 23, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP CT. AN UNKNOWN ENDOLEAK WAS IDENTIFIED. NO CAUSE AS PER PHYSICIAN WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469308 ↗