VALIANT® Captivia VAMC3838C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00643169347168), received between Mar 23, 2017 and Apr 24, 2018 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult To Position” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 24, 2018Difficult to Insert; Difficult To Position; Difficult to Insert; Difficult To Position

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS PLANNED TO BE IMPLANTED IN A PATIENT TO TREAT A 67 MM THORACIC ABDOMINAL AORTIC ANEURYSM. THE PATIENT WAS BEING TREATED FOR A THORACIC CO-ABDOMINAL REPAIR WITH ANOTHER INVESTIGATIONAL DEVICE. IT WAS REPORTED THAT THE VALIANT STENT GRAFT SYSTEM WAS INSERTED THROUGH THE RIGHT COMMON FEMORAL ARTERY BUT WOULD NOT PASS THROUGH THE RIGHT EXTERNAL ILIAC ARTERY. THE DIAMETER OF THE RIGHT EXTERNAL ILIAC ARTERY WAS 6 MM. THE PHYSICIAN THEN USED SEQUENTIAL DILATORS TO DILATE THE ETERNAL ILIAC ARTERY. WHILE REMOVING THE DILATORS, THE PATIENT'S BLOOD PRESSURE DROPPED AND THE EXTERNAL ILIAC ARTERY RUPTURED AND EMERGENCY TREATMENT WAS STARTED. A BALLOON WAS INFLATED IN THE DISTAL AORTA TO OCCLUDE THE ARTERY AND AN ANGIOGRAM WAS TAKEN TO SEE THE EXTENT OF THE RUPTURE. AN ENDURANT II LIMB WAS THEN DEPLOYED INTO THE RIGHT COMMON ILIAC ARTERY DOWN TO THE RIGHT COMMON FEMORAL TO COVER THE INJURY. HOWEVER, THE INJURY WAS TOO EXTENSIVE, AND THE PHYSICIAN THEN CUT DOWN ON THE COMMON FEMORAL SITE AND RETEROPERITONEAL TO ASSESS THE INJURY AND CLAMPED OFF THE BLEEDING ARTERY. A 10MM GRAFT WAS USED TO BYPASS THE RIGHT COMMON ILIAC ARTERY DOWN TO THE RIGHT COMMON FEMO

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 7453464 ↗
• InjuryMar 23, 2017Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A DISTAL TYPE I ENDOLEAK OF A VALIANT STENT GRAFT. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN. THE CT REVEALED A DISTAL TYPE I ENDOLEAK. THE PHYSICIAN DECIDED TO IMPLANT A VALIANT 38X38X100 ALONG WITH 8 APTUS ENDOANCHORS. THE FINAL ANGIOGRAM REVEALED THAT THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. THE PHYSICIAN COULD NOT DETERMINE THE CAUSE OF THE EVENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 6429426 ↗