VALIANT® Captivia VAMF3838C150TU (UDI 00613994797674)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994797674), received between Nov 14, 2018 and Nov 14, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Migration or Expulsion of Device” (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 18, 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.

• InjuryNov 14, 2018Migration or Expulsion of Device; Migration or Expulsion of Device

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT TO TREAT A THORACIC AORTIC ANEURYSM OF UNKNOWN SIZE. IT IS REPORTED THAT THE PATIENT PRESENTED WITH A LEFT PLEURAL EFFUSION APPROXIMATELY FIVE YEARS LATER. A CT WAS CARRIED OUT WHICH SHOWED THAT THE ANEURYSM HAD INCREASED PROXIMALLY AND THE STENT GRAFT HAD MIGRATED DISTALLY INTO THE ANEURYSM. AN INTERVENTION WAS CARRIED OUT WITH DEBRANCHING OF THE GREATER VESSELS. A LANDING ZONE WAS CREATED AND TWO VALIANT NAVION STENT GRAFTS (VNMC4343C225 AND VNMC4343C93) WERE IMPLANTED TO REALIGN THE EXISTING STENT GRAFT FROM THE ASCENDING AORTA TO DISTAL OF THE EXISTING STENT GRAFT. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS ANATOMY RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm; Pleural Effusion

  MAUDE report 8068889 ↗