Valiant Navion™ VNMF3428C173TURecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000100858), received between Nov 26, 2020 and May 22, 2024 — classified as 1 death, 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• DeathMay 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT (VNMF3428C173TU) WAS IMPLANTED DURING THE RE-INTERVENTION OF A THORACIC AORTIC REPAIR. THE PATIENT HAD AN EXISTING VALIANT CAPTIVIA THORACIC STENT GRAFT (VAMF4040C150TU) IMPLANTED. IT WAS REPORTED APPROXIMATELY 8 MONTHS POST THE NAVION IMPLANT PROCEDURE, FOLLOW UP CT SHOWED AN APPARENT HEMOTHORAX CONSISTENT WITH AORTIC RUPTURE.  THE IMAGING WAS NA FOR AORTIC ENLARGEMENT AND THE MAX AORTIC DIAMETER MEASURED AT 114MM. A STENT FRACTURE WAS DUE TO MULTIPLE OVERLAPPING DEVICES. NO STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED.  IT WAS REPORTED ON AN UNKNOWN DATE THAT THE PATIENT EXPIRED, THE CAUSE OF DEATH AND CIRCUMSTANCES SURROUNDING THE DEATH ARE UNKNOWN. THE CAUSE OF THE HEMOTHORAX AND AORTIC RUPTURE ARE UNDETERMINED.

  Patient problems: Hemothorax; Rupture

  MAUDE report 19372172 ↗
• MalfunctionAug 22, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. CORELAB REVIEW OF CT TAKEN ONE MONTH POST THE INDEX PROCEDURE SHOWED A NEW TYPE IA ENDOLEAK AND THE MAXIMUM AORTIC DIAMETER OF 54MM. NO STENT FRACTURE, NO STENT RING ENLARGEMENT AND NO STENT RING MIGRATION WERE IDENTIFIED. THE CAUSE OF THE ENDOLEAK IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17594299 ↗
• InjuryMay 29, 2023Fracture; Leak/Splash; Fracture; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE, ON FOLLOW UP CT THE PHYSICIAN NOTED CONTRAST OUTSIDE OF THE GRAFT IN THE ANEURYSM SAC. THE CAUSE IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17016762 ↗
• InjuryMar 27, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED BY THE PATIENT THAT FOLLOW UP CT ON AN UNKNOWN DATE IDENTIFIED LEAKING FROM THE STENT GRAFT THAT IS CONTINUING EVER SINCE. NO FURTHER INFORMATION WAS PROVIDED AT THIS TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 16617876 ↗
• InjuryMar 1, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT ON IMAGING , FABRIC DISINTEGRATION FROM STENT RING IN MID-PORTION OF ONE OF THE STENT GRAFTS WAS NOTED. THE PATIENT WAS TREATED THE FOLLOWING MONTH WITH A NON-MDT STENT GRAFT. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS CANNOT BE DETERMINED.   NO ADDITIONAL SEQUALAE WAS REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 16459200 ↗
• InjuryJan 18, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TYPE B THORACIC DISSECTION. IT WAS REPORTED BY THE PATIENTS WIFE REPORTED THAT THE PATIENT HAS UNDERGONE AN ADDITIONAL VASCULAR SURGERY APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE. CTA FINDINGS FROM APPROXIMATELY 32 MONTHS POST THE INDEX PROCEDURE SHOWED FALSE LUMEN PERFUSION. COMPARED TO CT EXAMINATION 26 MONTHS POST THE INDEX PROCEDURE SHOWS THERE REMAINS ENDOLEAK'S ABOUT THE AORTOILIAC BIFURCATION. THE NATIVE AORTA ABOUT THIS LEVEL REMAINS RELATIVELY UNCHANGED IN DIMENSION, CURRENTLY MEASURING 51 X 47 MM IN THE TRANSVERSE AND AP DIMENSIONS RESPECTIVELY. THERE ARE ADDITIONAL ENDOLEAK'S ABOUT THE DISTAL DESCENDING THORACIC AORTA AT THE LEVEL OF THE DIAPHRAGMATIC CRUS. LEFT COMMON ILIAC-SMA, AND LEFT COMMON ILIAC-BILATERAL RENAL ARTERY DEBRANCHED BYPASS GRAFTS REMAIN WIDELY PATENT. THERE IS GOOD VISCERAL PERFUSION OF THE BOWEL, LIVER, AND BILATERAL KIDNEYS FROM THESE BYPASS GRAFTS. PER THE PHYSICIAN THE CAUSE OF THE FALSE LUMEN AND ENDOLEAKS ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16193684 ↗
• MalfunctionJul 18, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT CORELAB REVIEW OF CTS FROM APPROXIMATELY 2YEARS AND 5 MONTHS POST INDEX PROCEDURE IDENTIFIED THE PRESENCE OF A TYPE IA ENDOLEAK.  NO CAUSE AS PER THE PHYSICIAN FOR THE TYPE IA ENDOLEAK WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15040662 ↗
• InjuryNov 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 50MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP FOUR YEARS LATER, A DISTAL TYPE IB ENDOLEAK WAS IDENTIFIED. INTERVENTION WAS PERFORMED THE NEXT DAY AND TWO VALIANT NAVION DEVICES PLUS AN ENDURANT LIMB (ETLW1620C93E) WAS IMPLANTED AS TREATMENT. IT WAS STATED IMMEDIATELY AFTER THE PROCEDURE, THE PATIENT WAS FOUND TO BE PARALYZED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Paralysis

  MAUDE report 10910937 ↗