VALIANT® Captivia VAMC4242C200TURecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00643169346734), received between Nov 29, 2017 and Jul 19, 2022 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 19, 2022Fracture; Fracture

  VALIANT STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A FUSIFORM DESCENDING THORACIC ANEURYSM. IT WAS NOTED A NON-MDT STENT GRAFT WAS PREVIOUSLY IMPLANTED IN THE ASCENDING AORTA 2 MONTHS PRIOR. IT WAS REPORTED A RETRO-RESPECTIVE CORE LAB REVIEW OF IMAGING FROM APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE IDENTIFIED A DISTAL MAIN STENT GRAFT FRACTURE ON VAMC4242C200TU (V07849952) IMPLANTED IN ZONE 4. THE CAUSE OF THE STENT FRACTURE IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15050622 ↗
• InjuryJul 19, 2021Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED RUPTURED ABDOMINAL AORTIC ANEURYSM. ANOTHER VALIANT CAPTIVIA WAS THEN IMPLANTED 2 MONTHS LATER. IT WAS REPORTED ON AN UNKNOWN DATE AFTER THE INDEX PROCEDURE, A TYPE IIIA ENDOLEAK BETWEEN THE 1ST AND 2ND COMPONENT WAS DIAGNOSED. A NON MDT STENT GRAFT WAS USED TO TREAT THIS ENDOLEAK ROUGHLY 3 MONTHS AFTER THE INDEX PROCEDURE. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12187215 ↗
• InjuryNov 30, 2018Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY ONE WEEK LATER, A TYPE III JUNCTIONAL ENDOLEAK WAS NOTED BETWEEN THE FIRST AND SECOND STENT GRAFTS IN ZONE 3. THE PATIENT WAS HOSPITALIZED AS A RESULT OF THIS EVENT. THE EVENT WAS ASSESSED BY THE INVESTIGATOR AS NOT RELATED TO THE DEVICE, RELATED TO THE PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS POSSIBLY RELATED TO THE DEVICE AND RELATED TO THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Injury

  MAUDE report 8120966 ↗
• InjuryNov 30, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A FUSIFORM DESCENDING THORACIC ANEURYSM. IT WAS NOTED A NON-MDT STENT GRAFT (GELWEAVE) WAS PREVIOUSLY IMPLANTED IN THE ASCENDING AORTA APPROXIMATELY 2 MONTHS PREVIOUSLY. IT WAS REPORTED FROM ONE POST THE INDEX PROCEDURE TO APPROXIMATELY 2 WEEKS POST THE INDEX PROCEDURE THE PATIENT EXPERIENCED THE FOLLOWING SYMPTOMS: THROMBOCYTOPENIA RESOLVING WITHOUT TREATMENT ABDOMINAL PAIN UNRESOLVED WITHOUT TREATMENT ELEVATED LIVER ENZYMES RECOVERING WITHOUT TREATMENT. ANEMIA WITH DROP IN HB UNRESOLVED AND CONTINUING WITH TREATMENT HYPOKALEMIA RESOLVED WITH TREATMENT CONSTIPATION RESOLVED WITH TREATMENT MACULOPAPULAR RASH BY RIGHT NECK AREA RELATED TO SURGICAL TAPE DRESSING USED FOR CENTRAL LINE ACCESS RESOLVED WITH TREATMENT. POSTOPERATIVE FEVER WITH SYMPTOMS OF HYPOVOLEMIC HYPONATREMIA, LACTIC ACIDOSIS¿ RELATED TO THE POST IMPLANTATION SYNDROME. THIS WAS SUCCESSFULLY TREATED AND CONFIRMED AS RESOLVED. OCCULT GASTROINTESTINAL BLEEDING TREATED HOWEVER UNRESOLVED AND CONTINUING WITH TREATMENT LEFT ARM SWELLING WITH MILD EDEMA AROUND THE INCISION SITE (PROCEDURE ACCESS) RESOLVED WITH TREATMENT. ALL OF THE R

  Patient problems: Anemia; Constipation; Electrolyte Imbalance; Fever; Hemorrhage/Blood Loss/Bleeding; Rash; Swelling

  MAUDE report 8119301 ↗
• InjuryNov 29, 2017Difficult to Remove; Difficult to Remove

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE REMOVAL OF THE SECOND VALIANT STENT GRAFT DELIVERY SYSTEM THERE WAS LEFT ILIAC LIMB PERFORATION. THE PHYSICIAN IMPLANTED ANOTHER MANUFACTURER¿S COVERED STENT IN THE LEFT COMMON ILIAC ARTERY EXTENDING INTO THE EXTERNAL ILIAC ARTERY. THE PERFORATION WAS EXCLUDED AND RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS RELATED TO THE PATIENT¿S ANATOMY;THE PATIENT¿S ARTERY HAD CONTRACTED/SPASMED WHEN THE DELIVERY SYSTEM WAS BEING REMOVED FROM THE PATIENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Perforation of Vessels

  MAUDE report 7069041 ↗