VALIANT® Captivia VAMF4040C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00643169347359), received between Apr 19, 2017 and Mar 29, 2023 — classified as 1 death, 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMar 29, 2023Malposition of Device; Malposition of Device

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT WHEN THE STENT GRAFT WAS IMPLANTED, IT THEN MIGRATED AND COVERED THE PATIENTS VISCERAL VESSELS. AS A RESULT, THE PHYSICIAN THEN CONVERTED TO A ABDOMINAL LAPAROTOMY TO FACILITATE THE GRAFT EXPLANT. THE STENT GRAFT WAS THEN EXPLANTED. NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT RECOVERED WELL POST THE OPEN REPAIR.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16636790 ↗
• InjuryFeb 20, 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 A 59MM THORACIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE STENT WAS DEPLOYED, AN ACCESS VESSEL DISSECTION WAS DISCOVERED POST REMOVAL OF THE DELIVERY SYSTEM. NON MDT COVERED STENTS WERE DEPLOYED. THERE WAS SOME SLIGHT BLEEDING NOTED POST COVERED STENT DEPLOYMENT. FEMORAL CUTDOWN WAS PERFORMED AND THE ACCESS VESSEL WAS REPAIRED SURGICALLY. PER THE PHYSICIAN THE CAUSE OF THE ACCESS DISSECTION IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Perforation of Vessels

  MAUDE report 16404268 ↗
• MalfunctionApr 6, 2021Leak/Splash; Leak/Splash

  A VALIANT CAPTIVA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 53MM X 59MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED ON THE DATE OF THE CT, SEVEN MONTHS LATER, A TYPE III ENDOLEAK WAS IDENTIFIED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11618601 ↗
• InjuryJul 3, 2020Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60MM * 100MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 4 YEARS AND 10 MONTHS LATER THE PATIENT PRESENTED WITH BACK PAIN AND A TYPE IA AND IB ENDOLEAK WAS OBSERVED ON CT. INTERVENTION WAS PERFORMED THE NEXT DAY, THE PHYSICIAN IMPLANTED A VNMF4343C103E, IT WAS REPORTED THERE WAS GREAT DIFFICULTY POSITIONING THIS DEVICE DUE TO SEVERE TORTUOSITY. DUE TO THE SEVERE ANGULATION THE TIP CAPTURE MECHANISM WOULD NOT RELEASE SO THE PHYSICIAN PERFORMED THE NON RELEASE TIP CAPTURE MECHANISM IN ORDER TO DEPLOY THE BARE SPRING. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND DUE TO DISEASE PROGRESSION OF THE DISTAL AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Injury; Pain

  MAUDE report 10229182 ↗
• MalfunctionAug 28, 2017Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  IT WAS REPORTED THAT PATIENT PRESENTED FOR FOLLOW UP WITH RIGHT LEG PAIN. A RECENT CT REVEALED THAT THE TALENT STENT GRAFT HAS MIGRATED DISTALLY INTO THE ANEURYSM SAC WITH A PROXIMAL TYPE I ENDOLEAK. THE TALENT STENT GRAFT HAS ALSO FOLDED OVER AND THERE IS KINKING IN THE RIGHT ILIAC LIMB THAT IS OCCLUDED. CURRENTLY THE INFRARENAL AORTIC NECK IS 37 MM IN DIAMETER. THE PHYSICIAN PERFORMED A RETROPERITONEAL INCISION FOR ACCESS OF THE DEVICE, AS THE SELECTED VALIANT DEVICE WAS 8 MM/24FR. THE FIRST VALIANT STENT GRAFT WAS ADVANCED WITH DIFFICULTY THROUGH THE PATIENT¿S ANATOMY AND IMPLANTED. THE PHYSICIAN ADVANCED ANOTHER VALIANT STENT GRAFT BUT COULD NOT GET THROUGH THE KINKED/TORTUOUS AREA OF THE LEFT ILIAC LIMB. THE PHYSICIAN THEN TRIED ANOTHER VALIANT STENT GRAFT BUT HAD THE SAME OUTCOME. THE IMPLANTED VALIANT STENT GRAFT WAS SLIGHTLY SHORT OF THE RENAL ARTERY AND HAD A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN RE-BALLOONED WITH A RELIANT BALLOON HOWEVER THE TYPE I ENDOLEAK REMAINED HOWEVER, THE PHYSICIAN STATED THE TYPE I ENDOLEAK SHOULD RESOLVE AFTER HEPARIN REVERSED. THE PHYSICIAN PERFORMED A FEMORAL-FEMORAL BYPASS. NO FOLLOW-UP IS SCHEDULED. THE PHYSICIAN STATED THAT THE CAUSES OF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6823406 ↗
• DeathApr 19, 2017Malposition of Device; Malposition of Device

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF THE PRE-OPERATIVE RUPTURE OF A 6.5 CM ASCENDING THORACIC AORTIC ANEURYSM. IT WAS NOTED THAT THE PATIENT WAS NOT STABLE ENOUGH TO HAVE AN OPEN REPAIR. IT WAS REPORTED THAT ENDOVASCULAR REPAIR OF THE CONTAINED RUPTURE WAS PERFORMED WITH A 40X40X100 VALIANT DEVICE. THE STENT GRAFT WAS DEPLOYED SUCCESSFULLY AND THE FINAL ANGIOGRAM SHOWED THAT THE RUPTURE HAD BEEN EXCLUDED. HOWEVER, THERE WAS STILL SEVERE AORTIC INSUFFICIENCY AND PRESSURE DROPPED RAPIDLY. UPON TRANSESOPHAGEAL ECHOCARDIOGRAPHY IT WAS DISCOVERED THAT ONE OF THE PATIENT¿S VALVE LEAFLETS HAD BEEN PINNED BY THE BARE SPRING. THE PHYSICIAN TRIED TO BALLOON THE PROXIMAL STENT GRAFT AND PULL IT DOWN TO RELEASE THE VALVE. THEY ALSO ATTEMPTED TO INSERT A GUIDE WIRE BEHIND THE GRAFT TO MOVE THE PROXIMAL EDGE. ALL ATTEMPTS FAILED AND THE PATIENT DIED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS RELATED TO PATIENT ANATOMY; SPECIFICALLY, THE DISTANCE BETWEEN THE CORONARY SINUS AND THE CORONARY ARTERIES, WHICH WAS THE LANDING ZONE FOR THE GRAFT TO MAXIMIZE PROXIMAL SEAL, COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WE

  Patient problems: Death; Low Blood Pressure/ Hypotension

  MAUDE report 6504678 ↗