VALIANT® Captivia VAMC4642C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169346680), received between May 22, 2024 and May 22, 2024 — classified as 1 injury.

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.

• InjuryMay 22, 2024Activation, Positioning or Separation Problem; Device Damaged by Another Device; Activation, Positioning or Separation Problem; Device Damaged by Another Device

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. THE PROXIMAL THORACIC AORTA DIAMETER AT IMPLANTATION MEASURED 40MM, WITH THE DISSECTION SPANNING A LENGTH OF 20MM. IT WAS REPORTED DURING THE INDEX PROCEDURE, THAT THE TAPERED PORTION OF THE VALIANT CAPTIVIA (VAMC4642C150TU) STENT GRAFT WAS DELIVERED NEAR A FOLD IN THE EXISTING OPEN GRAFT REPAIR. DURING DEPLOYMENT, THE INNER CURVE OF THE DEVICE INITIALLY MADE CONTACT WITH THE INNER CURVE OF THEWALL, THE STENT GRAFT WAS THEN RELEASED AND ROTATED DISTALLY. A LONG STENT GRAFT (46X200) PIECE WAS SUCCESSFULLY PLACED AND SEAL WAS ACHIEVED. PER THE PHYSICIAN THE CAUSE OF THE DEPLOYMENT ISSUE WAS ANATOMY RELATED. IT WAS SUSPECTED THAT THE DEVICE MAY HAVE INITIALLY DEPLOYED IN CONTACT WITH THE GRAFT FOLD BEFORE RELEASE AND ROTATION. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED, AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 19371984 ↗