VALIANT® Captivia VAMF3834C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169400160), received between Aug 31, 2022 and May 13, 2026 — classified as 1 death, 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Difficult to Remove” (2 reports).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2026Adverse Event Without Identified Device or Use Problem

  THREE VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING AN INITIAL STAGED ENDOVASCULAR PROCEDURE TO TREAT A 70MM SYMPTOMATIC THOR ACOABDOMINAL ANEURYSM. A PRE-OPERATIVE COMPUTED TOMOGRAPHY SCAN IDENTIFIED AN OCCLUDED LEFT SUBCLAVIAN ARTERY AND BILATERAL INTERNAL ILIAC OCCLUSION, AND THE EXTERNAL ILIAC ARTERIES WERE DESCRIBED AS DISEASED AND SMALL; A HIGH RISK FOR PARALYSIS WAS DISCUSSED PRIOR TO PROCEEDING IT WAS REPORTED THAT DURING THE INDEX PROCEDURE A 10 MM NON-MEDTRONIC STENT WAS PLACED IN THE LEFT EXTERNAL ILIAC ARTERY AND BALLOONED TO 10 MM FOR GRAFT PLACEMENT, AND THE THREE VALIANT CAPTIVIA STENT GRAFTS WERE PLACED FROM THE LEVEL OF THE LEFT CAROTID ARTERY DOWN TO THE CELIAC ARTERY IN THE FOLLOWING ORDER: VAMF3834C150TU PROXIMALLY, VAMC3632C150TU MIDDLE GRAFT AND VAMC3430C150TU DISTALLY. VISCERAL VESSELS WERE PRE-STENTED FOR A PLANNED SECOND-STAGE PROCEDURE. THE PATIENT INITIALLY TOLERATED THE PROCEDURE AND THEN DEVELOPED LEG WEAKNESS WITH SOME PARTIAL PARALYSIS ONE DAY POST-OPERATIVELY. THE PATIENT RETURNED TO THE OPERATING ROOM FOR PLACEMENT OF A SPINAL DRAIN AND A CAROTID-SUBCLAVIAN BYPASS, AND WAS REPORTED TO BE GRADUALLY IMPROVING WITH SOME MOVEMENT OF THE LEGS. IT W

  Patient problems: Ischemia; Muscle Weakness/Atrophy; Paralysis

  MAUDE report 25157990 ↗
• DeathOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED, DURING THE ENDOVASCULAR TREATMENT OF AN PENETRATING AORTIC ULCER. IT WAS REPORTED, ONE DAY POST THE INDEX PROCEDURE. THE PATIENT EXPIRED. PER THE PHYSICIAN, THE CAUSE OF DEATH IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED. AND THE PATIENT IS EXPIRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17994000 ↗
• InjurySep 14, 2023Difficult to Remove; Difficult to Remove

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 70MM TAA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE AFTER DEPLOYMENT OF THE DEVICE, WHILE RETRACTING THE DELIVERY SYSTEM OVER THE WIRE THE TIP BECAME STUCK IN THE EXTERNAL ILIAC ARTERY AND TORE THE VESSEL. THE DELIVERY SYSTEM WAS REMOVED AND INTERVENTION WAS PERFORMED BY IMPLANTING 3 NON-MDT COVERED STENTS IN THE RIGHT ILIAC ARTERY TO REPAIR THE ARTERY. PER THE PHYSICIAN THE CAUSE OF THE REMOVAL DIFFICULTIES AND RUPTURE IS UNDETERMINED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: Perforation of Vessels

  MAUDE report 17742816 ↗
• MalfunctionAug 31, 2022Difficult to Insert; Difficult to Remove; Difficult to Insert; Difficult to Remove

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN A PATIENT FOR THE TREATMENT OF A DISSECTION AND ENDOLEAK . 2 SENTRANT SHEATHS WERE ALSO USED DURING THE PROCEDURE.  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN COULD NOT GET THE STENT GRAFT DELIVERY SYSTEM TO DELIVER THROUGH EITHER SHEATH. THE SAME ISSUE OCCURRED WITH BOTH THE 24F AND 26F SHEATH. IT APPEARED TO GET CAUGHT ON THE VALVE, IT WAS REPORTED. IT WAS ALSO DIFFICULT FOR THE PHYSICIAN TO REMOVE THE SHEATH EVEN IF IT WAS INSERTED A SMALL AMOUNT. THERE WAS NO DAMAGE TO THE DELIVERY SYSTEM AND THE PHYSICIAN DECIDED TO DELIVER THE STENT GRAFT WITHOUT A SHEATH.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15327216 ↗