VALIANT® Captivia VAMC3434C200TURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169346772), received between Sep 11, 2017 and Nov 6, 2019 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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.

• MalfunctionNov 6, 2019Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION, EXTENDING THE ENTIRE LENGTH OF THE DESCENDING THORACIC AORTA. IT WAS REPORTED THAT DURING A FOLLOW-UP CT ON AN UNKNOWN DATE, IT WAS NOTED THAT THE PATIENT'S TYPE B DISSECTION WAS FILLING RETROGRADE, DUE TO A DISTAL FENESTRATION PRESSURIZING THE FALSE LUMEN AND INCREASING THE ANEURYSM SIZE. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO THE PATIENT'S ANATOMY, DUE TO THE DISTAL FENESTRATION.   NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9283609 ↗
• MalfunctionSep 11, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS ATTEMPTED FOR USE IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.0 CM THORACIC AORTIC ANEURYSM. IT WAS NOTED THAT THE PATIENT HAD PREVIOUSLY HAD ANOTHER MANUFACTURER¿S THORACIC STENT GRAFT IMPLANTED AND HAD DEVELOPED AN ANEURYSM AT THE DISTAL END. IT WAS ALSO NOTED THAT THE PATIENT HAD VERY TORTUOUS ANATOMY. IT WAS REPORTED THAT THE VALIANT DEVICE WAS ADVANCED TO WITHIN THE OTHER MANUFACTURE¿S GRAFT. AS THE STENT GRAFT WAS DEPLOYED THE GRAFT COVER AND THE STENT GRAFT MOVED TOGETHER. IT BECAME DIFFICULT FOR THE PHYSICIAN TO CONTINUE TO UNSCREW THE STENT GRAFT SO THE DEVICE WAS REMOVED. WHEN THE DEVICE WAS MOVED DISTALLY INTO A STRAIGHTER PORTION OF THE ANATOMY, PART OF THE FABRIC CAME FORWARD FROM UNDER THE GRAFT COVER. A DIFFERENT VALIANT DEVICE WAS THEN INSERTED AND WAS DEPLOYED NORMALLY WHICH RESOLVED THE EVENT. THE PHYSICIAN STATED THAT THE EVENT WAS CAUSED BY VERY TORTUOUS ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6854411 ↗