VALIANT® Captivia VAMF4036C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169400177), received between Jul 10, 2017 and Mar 15, 2024 — classified as 1 death, 3 injuries.

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

• DeathMar 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 88MM THORACOABDOMINAL ANEURYSM. THE PATIENT'S AORTA WAS NOTED AS DOUBLE S-SHAPED WITH SMALL ACCESS VESSELS AT THE ILIACS. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PATIENT'S ILIACS WERE TOO SMALL TO PLACE THE VALIANT CAPTIVIA SO A CONDUIT WAS PLACED FOR ACCESS. ONCE THE WIRES WERE PLACED A SENTRANT SHEATH WAS PLACED INTO THE CONDUIT AND THE VAMF4036C150TU WAS IMPLANTED INTO THE PATIENT. POWER INJECTOR RUN WAS TAKEN TO CONFIRM PLACEMENT BEFORE DEPLOYMENT AND IT WAS NOTICED THAT CONTRAST WAS STAGNANT IN THE AORTA. THE PATIENT DETERIORATED AND CPR WAS ADMINISTERED AND THE GRAFT WAS REMOVED. THE PATIENT EXPIRED. PER THE PHYSICIAN THE CAUSE OF DEATH WAS ANATOMY RELATED DUE TO UNFORESEEN ANATOMICAL COMPLICATIONS INCLUDING THE SMALL ACCESS REQUIRING A CONDUIT, DOUBLE S-SHAPED AORTA, AND THE PATIENTS' BODY HABITUS WAS SMALL. THE PATIENT HAD COMPLEX AND DISEASED ANATOMY, AND IN AN ATTEMPT TO FIX THE THORACIC ANEURYSM, THE AN INFRARENAL ANEURYSM RUPTURED . NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS EXPIRED.

  Patient problems: Rupture

  MAUDE report 18912845 ↗
• InjuryAug 23, 2022Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED FOR A 150 MM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT A CT PERFORMED IDENTIFIED A POSSIBLE TYPE 1A AND 1B ENDOLEAK. THERE ALSO APPEARS TO BE A NEW ENTRY TEAR DISTAL TOTHE STENT GRAFT. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Vascular Dissection

  MAUDE report 15276096 ↗
• InjuryAug 17, 2022Fracture; Leak/Splash; Fracture; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM . A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED 17 MONTHS LATER. THE PATENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH UNKNOWN SYMPTOMS, WHERE A CT WAS PERFORMED AND REVEALED AN ENDOLEAK  IN THE PROXIMAL DESCENDING AORTA WHERE 4 ENDOGRAFTS WERE PREVIOUSLY PLACED. THE PATIENT WAS BROUGHT TO THE OPERATING ROOM WHERE A ANGIOGRAM IN OR REVEALED A TYPE III ENDOLEAK COMING FROM 2 OF THE MOST PROXIMAL STENT GRAFTS, A VALIANT NAVION VNMF4646C103TU & A VALIANT CAPTIVA VAMF4036C150TU. THE PHYSICIAN STATED AT THE TIME IT WAS EITHER A DISJUNCTION AND/OR STENT FRACTURE. THE EVENT WAS TREATED ON THE SAME DAY WITH 3 VALIANT CAPTIVIA IMPLANTED TO RELINE THE THORACIC AORTA. AS PER THE PHYSICIAN, CAUSE OF THE EVENT CANNOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15238913 ↗
• InjuryJul 10, 2017Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  A VALIANT STENT GRAFT SYSTEM WAS INSERTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.2 CM IN DIAMETER ASCENDING THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE ANEURYSM IN THE ASCENDING AORTIC ANEURYSM WAS MOST LIKELY DUE TO AN ANASTAMOSIS FROM A PREVIOUS PROCEDURE OF HEART TRANSPLANT. THE PHYSICIAN WANTED TO AVOID AN OPEN REPAIR A PREVIOUS TRANSPLANT PATIENT AND CHOSE TO UTILIZE VALIANT STENT GRAFTS. THE PHYSICIAN MODIFIED THE VALIANT STENT GRAFT PRIOR TO THE INSERTION INTO THE PATIENT, SHORTENING THE VALIANT 40X40X150 GRAFT TO 80MM AND DEPLOYED IT IN A TRANSAPICAL APPROACH, TRYING TO LAND WITH THE GRAFT BETWEEN THE BRACHIOCEPHALIC ARTERY AND THE SINOTUBULAR JUNCTION. DURING DEPLOYMENT, THE VALIANT STENT GRAFT MOVED FORWARD AT THE END AND WAS 1CM DISTAL TO WHERE THE STENT GRAFT WAS INTENDED TO BE IMPLANTED. THERE WAS A PROXIMAL TYPE I ENDOLEAK AT THAT TIME. THE PHYSICIAN DECIDED TO USE A SECOND VALIANT STENT GRAFT, SHORTENING 40X36X150 TO 80 MM AND TRY TO LAND MORE PROXIMAL, RIGHT AT THE SINOTUBULAR JUNCTION. PREPARING TO DEPLOY THE SECOND VALIANT STENT GRAFT, IT WAS NOTICED THAT THE FIRST GRAFT HAD MIGRATED DISTALLY ABOUT 1CM. IT WAS NOW COVERING 85% OF THE BRACHIOCEPH

  Patient problems: Occlusion

  MAUDE report 6699420 ↗