VALIANT® Captivia VAMC4646C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169346642), received between May 12, 2017 and Mar 23, 2018 — classified as 2 injuries.

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.

• InjuryMar 23, 2018Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM AND A VALIANT STENT GRAFT WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ABDOMINAL AND THORACIC AORTIC ANEURYSMAL DISEASE. THE PATIENT'S PARTNER REPORTED THAT THE STENT GRAFTS HAD LEAKED AND A TOTAL BYPASS AND REPAIR WAS PERFORMED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7365445 ↗
• InjuryMay 12, 2017Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 9.2 CM IN DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN. THE CT SHOWED THAT THE DISTAL VALIANT STENT GRAFT HAD MIGRATED PROXIMALLY AWAY FROM THE CELIAC ARTERY WITH A DISTAL TYPE I ENDOLEAK AND ANEURYSM RUPTURE. THE PHYSICIAN ELECTED TO SNORKEL THE SMA AND RIGHT RENAL. ANOTHER MANUFACTURER¿S STENT WERE IMPLANTED INTO THE SMA AND RIGHT RENAL AND ANOTHER VALIANT STENT GRAFT WAS IMPLANTED. THE FINAL ANGIOGRAM SHOW THAT THE SNORKELS WERE PATENT AND THE MIGRATION AND DISTAL TYPE I ENDOLEAK WERE RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE MIGRATION AND DISTAL TYPE I ENDOLEAK IS RELATED TO THE PATIENT¿S ANATOMY, EXPANSION OF THE DISTAL THORACIC AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain; Rupture

  MAUDE report 6563945 ↗