VALIANT® Captivia VAMF2424C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169347021), received between Apr 23, 2018 and Apr 23, 2018 — classified as 1 malfunction.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC TRANSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, WHEN ATTEMPTING TO DEPLOY THE PROXIMAL BARESPRING, THE DEPLOYMENT KNOB HAD RESISTANCE AND WOULD NOT DISENGAGE. MULTIPLE ATTEMPTS WERE MADE AT THIS BEFORE DECIDING TO DISASSEMBLE THE HANDLE AND MANUALLY DEPLOY THE BARESPRING. AFTER HANDLE DISASSEMBLY, THE PROXIMAL TIPCAP WAS DEPLOYED AND THE DEVICE WAS RETRACTED OUT OF THE PATIENT. THE FINAL ANGIOGRAM IDENTIFIED NO VISIBLE DAMAGE TO THE VASCULATURE OR THE DEVICE. THE PATIENT HAD NORMAL DISTAL PULSES AT THE END OF THE CASE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7450034 ↗