VALIANT® Captivia VAMC3636C200TURecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169346765), received between Feb 4, 2020 and Dec 7, 2022 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Leak/Splash” (3 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.

• InjuryDec 7, 2022Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF AN ULCER.  IT WAS REPORTED WHEN THE PATIENT RETURNED AND A FOLLOW-UP CT SHOWED A TYPE III ENDOLEAK AND SAC EXPANSION. INTERVENTION WAS PERFORMED THE FOLLOWING DAY AND 2 VALIANT CAPTIVIAS WERE IMPLANTED. THIS RESOLVED THE EVENT. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND  THE 2 STENT GRAFTS POTENTIALLY RUBBING TOGETHER AT THE OVERLAP JUNCTION WHICH LED TO THE TYPE III ENDOLEAK.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15932580 ↗
• DeathSep 5, 2022Fracture; Leak/Splash; Fracture; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 70MM THORACIC ANEURYSM. AN OPEN ARCH REPAIR WAS ALSO PREFORMED. APPROXIMATELY 4 YEARS LATER 3 NAVION STENT GRAFTS WERE IMPLANTED. A SEVERE ANGULATED NECK WAS NOTED. IT WAS REPORTED APPROXIMATELY 6 YEARS POST THE INDEX PROCEDURE, AN INTERVENTION PROCEDURE WAS PERFORMED TO RELINE A PREVIOUS VALIANT STENT GRAFT (IMPLANTED IN 2016) DUE TO A FRACTURED GRAFT WITH A TYPE IIIB ENDOLEAK AND SAC INCREASE (100MM). IT WAS NOTED THE PATIENT ALSO PRESENTED WITH PAIN PRE THE INTERVENTION PROCEDURE. DURING THE INTERVENTION THE PHYSICIAN WAS UNABLE TO ADVANCE THE GRAFT (VAMC4444C200TU) THROUGH THE FRACTURED GRAFT FROM THE FEMORAL APPROACH. THE PHYSICIAN USED THE APEX APPROACH HOWEVER DUE TO THE ANGULATED ARCH THE GRAFT COULD NOT BE ADVANCED. THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE WITH BRADYCARDIA AND HYPOVOLEMIA AND WENT INTO CARDIAC ARREST. RESUSCITATION WAS UNSUCCESSFUL AND THE PATIENT EXPIRED. PER THE PHYSICIAN THE CAUSE OF THE FRACTURE, TYPE IIIB ENDOLEAK AND DEATH ARE UNDETERMINED.

  Patient problems: Bradycardia; Cardiac Arrest; Hypovolemia; Pain

  MAUDE report 15354678 ↗
• InjuryFeb 4, 2020Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT FOLLOW UP CT APPROXIMATELY THREE AND A HALF YEARS LATER SHOWED A TYPE III ENDOLEAK. A 37X27X183 CLOSED SEAL STENT GRAFT WAS IMPLANTED THE FOLLOWING DAY TO COVER THE JUNCTION WHERE THE LEAK WAS VISUALIZED ON ANGIO. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9664103 ↗