VALIANT® Captivia VAMC4238C150TU (UDI 00613994802903)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00613994802903), received between Jun 8, 2017 and Jun 8, 2017 — classified as 1 death.

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 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.

• DeathJun 8, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 37.2 CM IN LENGTH THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST AND ABDOMEN PAIN. THE CT FOUND A PROXIMAL TYPE I ENDOLEAK. THE INVESTIGATOR ELECTED TO SURGICAL PERFORM MEDIAL STERNOTOMY WITH REPLACEMENT OF ASCENDING AORTA, AORTIC DEBRANCHING AND GRAFT PLACEMENT WITH SEPARATE STENTS TO THE LEFT CAROTID AND INNOMINATE ARTERIES. SUBJECT HANDLED PROCEDURE WELL. IT WAS REPORTED THAT A THREE WEEKS LATER THE PATIENT PRESENTED WITH POST-OPERATIVE MASSIVE CHEST BLEED AND THE PATIENT EXPIRED. PER THE INVESTIGATOR, THE CAUSES OF THE EVENTS WERE RELATED TO THE PRE-EXISTING DISSECTION AND NOT RELATED TO THE STUDY DEVICE OR THE STUDY PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Blood Loss; Pain

  MAUDE report 6622837 ↗