VALIANT® Captivia VAMF4444C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169346925), received between Dec 13, 2016 and Sep 13, 2022 — classified as 1 injury, 1 malfunction.

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.

• InjurySep 13, 2022Adverse 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 70MM TAA.  IT WAS REPORTED 3 DAYS POST THE INDEX PROCEDURE, THE PATIENT RETURNED TO ER AFTER VOMITING. A CT WAS PERFORMED AND SHOWED A RETROGRADE TYPE B AORTIC DISSECTION. INTERVENTION WAS PERFORMED ON THE SAME DATE WHERE AN ADDITIONAL PROXIMAL THORACIC STENT GRAFT WAS IMPLANTED.  PER THE PHYSICIAN THE CAUSE OF THE DISSECTION WAS A DISEASED AORTA.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Vascular Dissection

  MAUDE report 15409567 ↗
• MalfunctionDec 13, 2016Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PROXIMAL TYPE I ENDOLEAK. IT WAS REPORTED THAT THE PATIENT HAD A RE-INTERVENTION. AFTER THE LEFT CAROTID ARTERY TO LEFT SUBCLAVIAN ARTERY PASS WAS PERFORMED A 44/44/150 VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED. POST ANGIOGRAM DEMONSTRATED THAT THE TYPE IA ENDOLEAK WAS NOT RESOLVED. A RELIANT BALLOON WAS GENTLY INFLATED AND THE LEAK SHOWED SLIGHT IMPROVEMENT. THE PATIENT TOLERATED THE PROCEDURE WITHOUT ANY INCIDENTS. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PATIENT. THE PHYSICIAN STATED THAT THE TYPE IA ENDOLEAK WAS MOST LIKELY CAUSED BY DISEASE PROGRESSION AND UNCONTROLLED HYPERTENSION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6170834 ↗