VALIANT® Captivia VAMF3434C150TU (UDI 00613994797698)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994797698), received between Nov 17, 2022 and Nov 17, 2022 — 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.

• InjuryNov 17, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. A VALIANT NAVION STENT GRAFT WAS IMPLANTED DUE TO CONTINUED DILATION OF THE AORTIC ANEURYSM 8 YEARS POST THE INDEX PROCEDURE IT WAS REPORTED APPROXIMATELY 8 MONTHS POST THE NAVION PROCEDURE, FOLLOW UP CT DEMONSTRATED A STABLE SMALL ENDOLEAK ADJACENT TO THE DISTAL ASPECT OF THE STENT GRAFT ANTERIORLY WITHIN THE PROXIMAL DESCENDING THORACIC AORTA. CT IMAGING 2 YEARS POST THE NAVION IMPLANT PROCEDURE SHOWED AN INCREASED DENSITY EXTENDING FROM THE ANTERIOR PROXIMAL MARGIN OF THE STENT WITH EXTENSION INTO THE INFERIOR ASPECT OF THE EXCLUDED ANEURYSM SAC CONSISTENT WITH A TYPE I ENDOLEAK. ON (B)(6) 2022 INTERVENTION WAS COMPLETED. NON MDT STENTS WERE IMPLANTED TO RESOLVE THE ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information; Pseudoaneurysm; Vascular Dissection

  MAUDE report 15815235 ↗