VALIANT® Captivia VAMC3228C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169346888), received between Feb 9, 2017 and Feb 9, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Folded” (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.

• InjuryFeb 9, 2017Occlusion Within Device; Folded; Occlusion Within Device; Folded

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM IN DIAMETER ULCER IN THE DESCENDING THORACIC AORTA. THE THORACIC AORTA WAS NON-TORTUOUS. TWO VALIANT STENT GRAFTS WERE DEPLOYED WITHOUT ISSUE. PRIOR TO THE DELIVERY OF THE THIRD VALIANT STENT GRAFT, THE GUIDEWIRE POSITIONING WAS LOST AND THEN REPOSITIONED. IT WAS REPORTED THAT AFTER THE THIRD DISTAL VALIANT STENT GRAFT WAS DEPLOYED THE TOP 1/3RD PORTION ON ONE SIDE OF THE STENT GRAFT APPEARED TO BE MAL-DEFORMED/INFOLDED/CRUSHED AND NOT FULLY OPPOSED AGAINST THE OTHER STENT GRAFT OR VESSEL WALL. AFTER STENT GRAFT DEPLOYMENT, THERE WAS A PRESSURE GRADIENT BETWEEN THE THORACIC AREA AND THE FEMORAL ARTERY AREA WAS MORE THAN 100 MM OF MERCURY DUE TO STENOSIS/THROMBOSIS FORMATION. THE PHYSICIAN ELECTED TO PERFORM AN AXILLO-BI-FEMORAL BYPASS. THE BLOOD FLOW WAS RESTORED. THE PHYSICIAN STATED THE CAUSE OF THE EVENT IS RELATED TO THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 6317868 ↗