VALIANT® Captivia VAMF2424C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169347113), received between Jan 25, 2017 and Apr 5, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Defective Component” (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.

• MalfunctionApr 5, 2022Defective Component; Defective Component

  A VALIANT CAPTIVA STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ULCER. IT WAS REPORTED DURING THE INDEX PROCEDURE, IT WAS NOTED THAT THE DELIVERY SYSTEM HAD A GAP/SEPARATION FROM THE TIP TO THE GRAFT COVER AND IT WOULD NOT SEAL PROPERLY. THE DEVICE WAS NOT IMPLANTED IN THE PATIENT AND A NEW DEVICE WAS USED. PER PHYSICIAN THE CAUSE OF THE GAP WAS DUE TO THE DELIVERY SYSTEM. NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14011318 ↗
• InjuryJan 25, 2017Malposition of Device; Malposition of Device

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC TRANSECTION DUE TO A MOTOR VEHICLE ACCIDENT. IT WAS REPORTED THAT THE PHYSICIAN UNINTENTIONALLY COVERED THE LEFT SUBCLAVIAN ARTERY. ACCESS WAS GAINED THROUGH THE PATIENT¿S ARM AND A SNORKEL WAS PLACED. IT WAS NOTED THAT A BYPASS WAS NOT AN OPTION DUE TO THE PATIENT¿S INJURIES. THE FINAL ANGIOGRAM SHOWED THE LEFT SUBCLAVIAN AND VERTEBRAL ARTERY WERE FILLING. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DUE TO THE PIGTAIL COMING BACK WITH PARTIAL FILLING OF THE SUBCLAVIAN, WHICH LED TO AN INACCURATE MARK ON THE SCREEN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 6277811 ↗