VALIANT® Captivia VAMC4646C200TURecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169346437), received between Sep 19, 2017 and Oct 26, 2018 — classified as 1 death, 2 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryOct 26, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 80MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE (POST SUCCESSFUL DELIVERY OF THE STENT GRAFTS) WHEN THE SHEATH WAS BEING REMOVED THE ILIAC ARTERY RUPTURED. AN OPEN PROCEDURE WAS PERFORMED TO REPAIR THE RUPTURED ILIAC ARTERY. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO PATIENT ANATOMY; SMALL ILIAC ACCESS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Perforation of Vessels

  MAUDE report 8008278 ↗
• DeathJul 11, 2018Adverse Event Without Identified Device or Use Problem

  A VALIANT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT ON A 63MM DIAMETER THORACIC AORTIC ANEURYSM. DURING THE INDEX PROCEDURE IT WAS REPORTED THAT AS THE DEVICE WAS BEING ADVANCED THE PATIENTS ARTERIAL PRESSURE DROPPED AND THERE WAS A LOSS OF HEART RHYTHM. THE PROCEDURE WAS CONVERTED TO AN OPEN REPAIR AND IT WAS NOTED THAT THERE WAS A TEAR PRESENT IN THE AORTA DISTAL TO THE LEFT SUBCLAVIAN ARTERY. THE STENT GRAFT WAS PASSED ACROSS THE TEAR AND DEPLOYED. A DISTAL EXTENSION WAS ALSO THEN DEPLOYED. IT WAS REPORTED THAT THE PATIENT EXPIRED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO THE PATIENT HAVING A TYPE 3 AORTIC ARCH. THE PHYSICIAN ADDITIONALLY NOTED THAT NO OVERT AGGRESSIVE PRESSURE WAS EXERTED. IT WAS ALSO NOTED THAT ON OPENING THE CHEST THE AORTA FELT VERY THIN. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED.

  Patient problems: Death; Loss Of Pulse

  MAUDE report 7676817 ↗
• InjurySep 19, 2017Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW UP ON AN UNKNOWN DATE. A RECENT CT REVEALED A TYPE III SEPARATION ENDOLEAK BETWEEN TWO VALIANT STENT GRAFTS. THE PHYSICIAN ELECTED TO IMPLANT ANOTHER VALIANT STENT GRAFT AND THE TYPE III SEPARATION ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE TYPE III SEPARATION ENDOLEAK WAS DUE TO THE PATIENT¿S ANATOMY REMODELING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6875657 ↗