VALIANT® Captivia VAMC4646B100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169347250), received between May 20, 2021 and Nov 15, 2022 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (2 reports).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT AND A VALIANT CAPTIVIA STENT GRAFT WERE IMPLANTED DURING AN ENDOVASCULAR TREATMENT. 2 ENDURANT II STENT GRAFTS (ETBF3216C145E AND ETLW1616C93E) WERE IMPLANTED APPROXIMATELY 5 YEARS PREVIOUS. 2 TALENT THORACIC STENT GRAFTS (TW4238C111CP <(>&<)> TF4242C198CP) WERE IMPLANTED APPROXIMATELY 8 YEARS PREVIOUS. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING FROM (B)(6) 2021 FOR THE NAVION GRAFT IDENTIFIED A NEW TYPE IB ENDOLEAK. NO STENT RING ENLARGEMENT WAS OBSERVED. THE IMAGING WAS NOTED AS NE FOR FRACTURE AND STENT RING MIGRATION DUE SCAN QUALITY AND OVERLAPS. A TYPE IA ENDOLEAK ON A PROXIMAL NON-NAVION GRAFT WAS IDENTIFIED. AN UNKNOWN INTERVENTION WAS COMPLETED. THE CAUSE OF THE ENDOLEAKS ARE UNDETERMINED. IT WAS NOTED TYPE IB ENDOLEAK DUE TO COMPLETE LOSS OF SEAL ON DISTAL END OF DEVICE (NO CONTRAST GOING INTO THE ANEURYSM SAC, BUT IF THERE¿S NO SEAL AT ALL, IT¿S THE SAME AS A TYPE I (A OR B DEPENDING ON THE END). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15796108 ↗
• MalfunctionMay 20, 2021Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED ON THE DATE OF THE CT, A TYPE IB ENDOLEAK WAS IDENTIFIED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY AND DISEASE PROGRESSION. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11855606 ↗