VALIANT® Captivia VAMC3636C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00643169347175), received between May 25, 2017 and May 25, 2017 — classified as 1 injury.

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.

• InjuryMay 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. AN ENDARTERECTOMY WAS PERFORMED PRIOR TO IMPLANTING THE STENT GRAFT DUE TO CALCIFIED ILIAC ARTERIES. DURING THE PROCEDURE, AFTER THE DELIVERY SYSTEM WAS REMOVED, THE PATIENT¿S BLOOD PRESSURE BEGAN TO FALL. AN ANGIOGRAM REVEALED THE APPEARANCE OF A SMALL BLUSH IN THE LEFT EXTERNAL ILIAC ARTERY, WHICH THE PHYSICIAN CONSIDERED TO BE A PERFORATION. THE PHYSICIAN ELECTED TO IMPLANT TWO COVERED STENTS IN THE LEFT ILIAC ARTERY AND THE EVENT WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE VESSEL PERFORATION WAS DUE TO THE PATIENT ANATOMY OF HEAVILY CALCIFIED ILIAC ARTERIES. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Perforation of Vessels

  MAUDE report 6592938 ↗