VALIANT® Captivia VAMC4444C200TURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169346444), received between Sep 5, 2022 and Sep 5, 2022 — classified as 1 death.

The most frequently reported specific device problem is “Fracture” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• DeathSep 5, 2022Fracture; Leak/Splash; Positioning Problem; Fracture; Leak/Splash; Positioning Problem

  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 15354683 ↗