VALIANT® Captivia VAMF3838C200TU (UDI 00613994797971)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994797971), received between Mar 31, 2017 and Mar 31, 2017 — classified as 1 injury.

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.

• InjuryMar 31, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8.6 CM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT A CT TAKEN, REVEALED GROWTH IN THE ANEURYSM SAC WITHOUT ANY EVIDENCE OF AN ENDOLEAK. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE PATIENT RECEIVED AN INTERVENTION WHERE THE PHYSICIAN IMPLANTED PROXIMAL AND DISTAL EXTENSIONS WITH APTUS ENDOANCHORS IN ORDER TO IMPROVE THE SEAL ZONES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm

  MAUDE report 6450932 ↗