VALIANT® Captivia VAMF4040C150TU (UDI 00613994797667)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00613994797667), received between Apr 24, 2018 and May 22, 2024 — classified as 1 death, 1 injury.

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 16, 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.

• 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 NE 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 19372179 ↗
• InjuryApr 24, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 78MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY AFTER BEING FOUND UNRESPONSIVE DUE TO A CARDIAC ARREST APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE. THE PATIENT WAS REVIVED AND TRANSFERRED TO ICU. ON CTA WHICH WAS PERFORMED AT THE HOSPITAL, A TYPE IB/TYPE IA ENDOLEAK WAS DEMONSTRATED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Cardiac Arrest

  MAUDE report 7453456 ↗