VALIANT® Captivia VAMF4444C200TU (UDI 00613994798008)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994798008), received between Dec 16, 2020 and Dec 16, 2020 — classified as 1 death.

The most frequently reported specific device problem is “Leak/Splash” (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.

• DeathDec 16, 2020Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 65.4MM RUPTURED THORACIC AORTIC ANEURYSM. IT WAS REPORTED OVER 7 YEARS LATER, THE PATIENT PRESENTED TO EMERGENCY ROOM. A CT REVEALED AN INCREASE IN ANEURYSM SIZE LIKELY DUE TO A TYPE III ENDOLEAK. TWO DAYS LATER, AN URGENT TEVAR PROCEDURE WAS PERFORMED. THE PHYSICIAN STATED IT WAS BELIEVED THE BARE STENT OF THE VAMF3636C200TJ HAD ERODED THROUGH THE FABRIC OF THE VAMF4444C200TU STENT GRAFT CAUSING THE SUSPECTED TYPE III ENDOLEAK. DURING THE INTERVENTION A VALIANT NAVION WAS IMPLANTED TO COVER THE TEAR AND ENDOLEAK WAS RESOLVED FOLLOWING ITS DEPLOYMENT. THE PATIENT SURVIVED THE PROCEDURE, BUT POST-OPERATIVELY DEVELOPED A CLOT IN THE RIGHT LUNG WHICH A TEST TUBE WAS UNABLE TO CLEAR. THE PATIENT BECAME ACIDOTIC AND EXPIRED ON AN UNKNOWN DATE. IT WAS SAID THE PHYSICIAN IN CONSULTATION WITH THE PATIENTS FAMILY DECIDED TO FORGO ROUTINE FOLLOW-UP SCANS FOR THIS PATIENT 3 YEARS PREVIOUSLY AS THERE WAS NO FURTHER ENDOVASCULAR TESTAMENT OPTIONS AVAILABLE AND IT WAS KNOWN THE PATIENT WAS UNLIKELY TO SURVIVE AN OPEN REPAIR. AS PER THE PHYSICIAN THE CAUSE OF THE IIIB ENDOLEAK WAS THE BARE STENT OF THE DISTAL DEVICE ERO

  Patient problems: Embolism/Embolus; Rupture

  MAUDE report 11018161 ↗