VALIANT® Captivia VAMC3434B100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169347311), received between Mar 28, 2018 and Mar 28, 2018 — classified as 1 injury.

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 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 28, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 96 MM SACCULAR THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT HAD PRESENTED EMERGENTLY APPROXIMATELY 3 YEARS POST INDEX PROCEDURE AND CT SHOWED HEMOTHORAX AND A LARGE PLEURAL EFFUSION BUT NO EVIDENCE OF ENDOLEAK. A THORACOCENTESIS WAS PERFORMED AND 1 LITRE OF BLOODY FLUID WAS REMOVED FROM THE LEFT CHEST. AN AORTIC ANGIOGRAM WAS THEN PERFORMED, WHICH SHOWED A CLEAR ENDOLEAK. THE PHYSICIAN NOTED THAT THE ENDOLEAK IS BELIEVED TO BE A TYPE III (SUBTYPE UNKNOWN) AND THAT AN AORTIC RUPTURE HAD ALSO OCCURRED. INTERVENTION WAS PERFORMED WITH THE IMPLANTATION OF A 36X150 VALIANT STENT GRAFT LANDING 2 CM PROXIMAL TO THE PROXIMAL INDWELLING STENT GRAFT AND JUST DISTAL TO THE LOWEST INDWELLING STENT GRAFT. THE ENTIRE STENT GRAFT WAS BALLOONED WITH A RELIANT BALLOON AND FINAL ANGIOGRAM SHOWED THE ENDOLEAK WAS RESOLVED. THE PATIENT RECOVERED WELL POST-SURGERY. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO A TYPE III ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Dyspnea; Hemothorax; Pleural Effusion; Rupture

  MAUDE report 7377009 ↗