VALIANT® Captivia VAMC3030C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169347205), received between Feb 27, 2018 and Feb 27, 2018 — classified as 1 death.

The most frequently reported specific device problem is “Malposition of Device” (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.

• DeathFeb 27, 2018Migration or Expulsion of Device; Malposition of Device; Migration or Expulsion of Device; Malposition of Device

  A VALIANT THORACIC STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A COARCTIC THORACIC AORTA. IT WAS REPORTED, SOMETIME AFTER THE PROCEDURE THE PATIENT EXPERIENCED A RISE IN BASELINE CREATINE LEVELS AND WHITE BLOOD CELL COUNT. KUB SHOWED THE STENT GRAFT SYSTEM HAD MIGRATED DISTALLY TO THE LEVEL OF THE L1-L2, AND WAS NOW IMPEDING BLOODFLOW TO THE VISCERAL BLOOD VESSELS. ON (B)(6) 2018, THE PATIENT EXPERIENCED CARDIAC ARREST AND CPR WAS ADMINISTERED. THE PHYSICIAN DECIDED TO EXPLANT THE STENT GRAFT SYSTEM, AN EXPLORATORY LAPAROTOMY WAS ALSO PERFORMED TO ASSESS THE CONDITION OF THE SMALL AND LARGE BOWEL FUNCTIONS AND A WOUND VAC WAS PLACED. THE PATIENT WAS TRANSFERRED TO ICU AFTER THE PROCEDURE AND WAS CONTINUED TO BE MONITORED. IT WAS REPORTED THAT THE PATIENT EXPIRED FROM MULTISYSTEM ORGAN FAILURE FOLLOWING ABDOMINAL EXPOSURE AND EXPLANT OF THORACIC ENDOGRAFT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Cardiac Arrest; Death; Obstruction/Occlusion; Occlusion; Pain; Renal Failure

  MAUDE report 7298733 ↗