VALIANT® Captivia VAMF3434C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169347069), received between May 14, 2018 and Jul 25, 2023 — classified as 2 deaths, 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (4 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 25, 2023Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A BTAI. IT WAS REPORTED THAT 8 DAYS LATER, THE PATIENT PRESENTED EMERGENTLY WITH CHEST PAIN AND A CTA SHOWED A SUSPECTED TYPE IA ENDOLEAK. IT WAS NOTED THAT THE PATIENT IS HAVING ISSUES WITH THEIR CHF AND WAS TRANSFERRED TO ANOTHER HOSPITAL. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNKNOWN. NO ADDITIONAL  CLINICAL SEQUELAE WERE PROVIDED WILL BE MONITORED.

  Patient problems: Chest Pain

  MAUDE report 17387132 ↗
• DeathFeb 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA .  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH CHEST PAIN. A CT PERFORMED REVEALED A 90MM CONTAINED RUPTURED TAA IN THE DESCENDING THORACIC AORTA BELOW THE LEVEL OF THE GRAFTS.  EMERGENT ENDOVASCULAR TREATMENT WAS PERFORMED THE PHYSICIAN PLACED A VAMF3838C150TU BUT DID NOT DEPLOY IT AS THE PATIENT CODED AND THEN EXPIRED. IT WAS CONFIRMED THIS STENT GRAFT DID NOT CAUSE OR CONTRIBUTE TO THE DEATH. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND AORTIC DEGENERATION.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Pain; Rupture

  MAUDE report 16385387 ↗
• InjuryMay 13, 2022Malposition of Device; Malposition of Device

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ULCER. A LEFT CAROTID SUBCLAVIAN BYPASS, LIGATION OF THE LEFT SUBCLAVIAN ARTERY, TEVAR, AND OPEN AORTIC BIFEMORAL BYPASS FOR AN INFRARENAL AORTIC OCCLUSION WAS PLANNED. IT WAS REPORTED DURING THE INDEX PROCEDURE THE PLANNED LEFT CAROTID SUBCLAVIAN BYPASS, LIGATION OF THE LEFT SUBCLAVIAN ARTERY, TEVAR, AND OPEN AORTIC BIFEMORAL BYPASS FOR AN INFRARENAL AORTIC OCCLUSION WERE COMPLETED WITH OUT ISSUE. THE PHYSICIAN ACCESSED THE RIGHT COMMON FEMORAL VEIN AND ADVANCED A PACING CATHETER TO THE HEART DURING THE GRAFT DEPLOYMENT. THE INFRARENAL AORTA WAS ACCESSED PROXIMAL TO THE INFRARENAL AORTA OCCLUSION AND A LUNDERQUIST WAS ADVANCED TO THE ASCENDING AORTA. THE INFRARENAL AORTA WAS ACCESSED A SECOND TIME AND A MARKER PIG TAIL CATHETER WAS PLACED IN THE AORTIC ARCH. THE 34X34X100 VALIANT CAPTIVIA GRAFT WAS ADVANCED TO THE AORTIC ARCH. AT THIS TIME THE PACING CATHETER WAS TURNED ON AND AN ANGIOGRAM WAS PREFORMED. THE GRAFT WAS DEPLOYED AND APPEAR TO "JUMP" FORWARD ONCE THE GRAFT WAS FULLY DEPLOYED. ONCE THE GRAFT WAS DEPLOYED THE PACING WAS TURNED OFF AND AN ANGIOGRAM WAS PREFORMED SHOWING T

  Patient problems: Obstruction/Occlusion

  MAUDE report 14394397 ↗
• InjuryOct 19, 2020Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A GREATER THAN 50MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT AN ANGIOGRAM PERFORMED THREE AND A HALF YEARS LATER SHOWED AN ENLARGING ANEURYSM DUE TO A TYPE IA <(>&<)> TYPE IIIB ENDOLEAK. INTERVENTION WAS PERFORMED ON THE SAME DATE AND THE STENT GRAFT WAS RELINED WITH TWO VALIANT NAVION STENT GRAFTS. THIS RESOLVED THE ENDOLEAKS. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS THE ENDOLEAKS. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Injury; Insufficient Information

  MAUDE report 10696243 ↗
• InjuryApr 12, 2019Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A NON MDT STENT GRAFT SYSTEM FOR THE TREATMENT OF A TYPE IIIB ENDOLEAK. TAA DIAMETER MEASURES 67 X 65MM THORACIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY 9 MONTHS POST IMPLANT, FOLLOW UP CT REVEALED THE ENDOGRAFT CONSTRUCT DISPLACED CAUDALLY CAUSING A TYPE IA ENDOLEAK WITH SUBSEQUENT ANEURYSM SAC EXPANSION. INTERVENTION WAS PERFORMED. THE MAIN BODY OF THE ENDOGRAFT CONSTRUCT WAS EXPLANTED AND A TUBE GRAFT SEWED IN ITS PLACE RESOLVING THE EVENT. IT WAS NOT POSSIBLE TO IDENTIFY WHICH DEVICE HAD THE TYPE IA ENDOLEAK. IT WAS REPORTED THAT DURING THE EXPLANT THERE WAS GRUMOUS MATERIAL PRESENT, BUT NO NEW BLOOD. A DISTINCT ENDOLEAK WASN'T IDENTIFIABLE ON PRE-OPERATIVE SCANS. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO MULTIPLE FAILURES IN THE NON MDT STENT GRAFT RESULTING IN OVERALL FAILURE OF THE ENDOGRAFT CONSTRUCT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8508213 ↗
• MalfunctionDec 21, 2018Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM OF UNKNOWN SIZE. IT WAS REPORTED THAT DURING A FOLLOW UP CT APPROXIMATELY 1 YEAR AND 1 MONTH POST IMPLANT, A TYPE IA ENDOLEAK WAS NOTED, WITH ANEURYSM SAC ENLARGEMENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. THE PHYSICIAN IS UNSURE IF THE LEAK OCCURRED DURING THE INDEX PROCEDURE OR POST-OP. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED..

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8188786 ↗
• DeathMay 14, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 44 MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT AFTER THE DELIVERY SYSTEM WAS REMOVED AN ENDARTERECTOMY WITH A PATCH WAS PERFORMED ON THE LEFT FEMORAL ARTERY. THE PATIENT HAD GOOD PULSES AND VITAL SIGNS AT THE END OF THE PROCEDURE. HOWEVER, LATER THAT DAY, THE PATIENT PRESENTED WITH CONFUSION AND A DROP IN PRESSURES AND THE PATIENT DIED. THE PHYSICIAN REPORTED THE CAUSE OF THE EVENT TO BE AS A RESULT OF UNDIAGNOSED BLEEDING FROM THE FEMORAL ARTERY REPAIR THAT OCCURRED DURING THE INDEX PROCEDURE. THE PATCH ON THE FEMORAL ARTERY BLEED INTO THE RETRO PERITONEAL SPACE. THE PHYSICIAN CONFIRMED THAT THE DEVICE DID NOT CAUSE A TEAR TO THE FEMORAL ARTERY AND DID NOT CAUSE THE BLEED LATER THAT NIGHT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Blood Loss; Death

  MAUDE report 7509982 ↗