VALIANT® Captivia VAMC3838C150TU (UDI 00643169346840)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169346840), received between Jan 9, 2017 and Jun 25, 2019 — classified as 2 deaths, 6 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 64MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT 5 DAYS LATER, FOLLOW UP IDENTIFIED ENLARGING OF THE DISTAL THORACIC AORTA. THREE WEEKS LATER, AN ADDITIONAL ENDURANT STENT GRAFT WAS IMPLANTED DISTALLY. BALLOONING WAS COMPLETED PROXIMALLY AND DISTALLY WITH NO EVIDENCE OF ENDOLEAK AT THE END OF THE PROCEDURE. IT WAS REPORTED THE PATIENT RECEIVED PRBCS FOR TREATMENT OF POST SURGICAL ANEMIA. PER THE INVESTIGATOR THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm

  MAUDE report 8730032 ↗
• MalfunctionJan 9, 2019Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 64 MM THORACIC AORTIC ANUERYSM. IT WAS REPORTED THAT THE PROCEDURE ANGIOGRAM SHOWED AN UNKNOWN TYPE ENDOLEAK. THE CAUSE OF THE EVENT IS UNKNOWN. NO INTERVENTION WAS REQUIRED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 8231315 ↗
• InjuryDec 27, 2018Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIASTENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 64 MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT'S TWO YEAR FOLLOW UP CT SHOWED A TYPE IA ENDOLEAK. THE CAUSE OF THE EVENT IS UNKNOWN. NO INTERVENTION WAS REQUIRED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 8198699 ↗
• InjurySep 17, 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 THORACIC DISSECTION OF >200MM LENGTH. IT WAS REPORTED THAT APPROXIMATELY 6 MONTHS LATER THE PATIENT PRESENTED EMERGENTLY WITH FLANK PAIN. A CT SCAN IDENTIFIED A NEW TEAR IN THE INTIMAL LINING WITH FOCAL CONTRAST. ON THE FOLLOWING DAY, INTERVENTION WAS PERFORMED WHERE A 32X32X150 STENT GRAFT WAS IMPLANTED AT THE CELIAC AND BRIDGED PROXIMALLY WITH AN ADDITIONAL STENT GRAFT (28X28X150). THE INTERVENTION WAS SUCCESSFULLY COMPLETED AND THE EVENT WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Intimal Dissection; Pain

  MAUDE report 7880325 ↗
• InjuryJun 13, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A RUPTURED THORACIC AORTA. DURING THE INDEX PROCEDURE, IT WAS REPORTED THAT AFTER THE STENT GRAFT HAD BEEN DEPLOYED TO THE DESIRED LOCATION, THE PROXIMAL STENT RING APPEARED DEFORMED AND ¿BIRD-BEAKED¿ AND AN ANGIOGRAM SHOWED CONTRAST TO BE FLOWING AROUND/BEHIND THE STENT GRAFT. A SECOND STENT GRAFT WAS IMPLANTED TO EXTEND PROXIMALLY AROUND THE ARCH AS FAR AS THE SUBCLAVIAN ARTERY. THE OVERLAPPED AREA OF THE STENT GRAFT WAS THEN BALLOONED WHICH RESOLVED THE DEFORMATION. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7596123 ↗
• DeathMar 20, 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 THORACIC DISSECTION. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY ON APPROXIMATELY AND A TYPE A RETROGRADE DISSECTION WAS DIAGNOSED. THE PATIENT RECEIVED AN UNKNOWN TREATMENT. THE PATIENT EXPIRED ON AN UNKNOWN DATE. AS PER THE PHYSICIAN, THE CAUSE OF THE DISSECTION OF DEATH IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Vascular Dissection

  MAUDE report 7353577 ↗
• InjuryNov 9, 2017Malposition of Device; Malposition of Device

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60 MM DIAMETER ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN FIRST PLACED A PROXIMAL GRAFT AT THE LSA. THE PHYSICIAN BROKE SCRUB TO WASH OFF BLOOD FROM FACE AND THEN RETURNED. THE PHYSICIAN THEN ADVANCED THE DISTAL GRAFT IN TO PLACE AND DEPLOYED IT. HOWEVER, THE DISTAL GRAFT WAS PLACED OUTSIDE OF THE PROXIMAL GRAFT AND WAS NOT OVERLAPPING. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS USER ERROR, IN THAT THE GUIDE WIRE MUST HAVE COME BACK WHILE BREAKING TO SCRUB. THIS WAS NOT READILY APPARENT NOR COULD THE DOCTOR TELL THAT THE GRAFT WAS DEPLOYED OUTSIDE OF THE FIRST GRAFT. TO RESOLVE THE ISSUE, A GUIDE WIRE WAS ADVANCED INTO THE LUMEN OF THE PROXIMAL GRAFT AND A DISTAL GRAFT WAS OVERLAPPED AND DEPLOYED IN THE SAME LUMEN. THE FINAL ANGIOGRAM SHOWED NO ENDOLEAKS AND ALL VISCERAL VESSELS PATENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7012509 ↗
• InjuryAug 29, 2017Malposition of Device; Malposition of Device

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT A VALIANT 38X38X200 WAS IMPLANTED PROXIMALLY. THE PHYSICIAN IMPLANTED ANOTHER VALIANT 38X38X150 DISTALLY HOWEVER, IT WAS INADVERTENTLY IMPLANTED SHORT OF THE INTENDED LANDING ZONE. ANOTHER VALIANT STENT GRAFT 38X38X200 WAS IMPLANTED AND THE GRAFT LANDED AT THE DESIRED DISTAL TARGET. FINAL ANGIOGRAM SHOWED NO ENDO-LEAKS AND THE TAA WAS COMPLETELY EXCLUDED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS RELATED TO THE USER¿S TECHNIQUE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6826327 ↗
• DeathJan 9, 2017Difficult To Position; Difficult to Remove; Difficult To Position; Difficult to Remove

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A 5.4 CM IN DIAMETER THORACIC AORTIC ANEURYSM. THE PATIENT PRESENTED EMERGENTLY WITH CHEST PAIN TWO DAYS PRE IMPLANT. THE CT REVEALED THAT THERE WAS A TAA AND AAA. PRE-PROCEDURE IT WAS NOTED THAT THE PATIENT¿S BLOOD PRESSURE WAS HYPERVOLEMIC. UP TO 300 SYSTOLIC (UNABLE TO CONTROL THE BLOOD PRESSURE PRIOR TO IMPLANT). THE PATIENT WAS NOT AN OPEN SURGICAL CANDIDATE. PATIENT HAD SEVERELY DISEASED VESSELS. THE PATIENT HAD MODERATELY TO SEVERE CALCIFIED ILIAC ARTERIES, PROXIMAL STENOSIS AND SMALL IN DIAMETER (5MM TO 9MM) ARTERIES. THE PHYSICIAN WAS AWARE THE PATIENT MAY NEED A RETROPERITONEAL CUT DOWN DUE TO THE SMALL IN DIAMETER ACCESS VESSEL. THE PHYSICIAN PERFORMED A CUT DOWN OF THE RIGHT COMMON FEMORAL ARTERY TO GAIN CONTROL OF THE VESSEL WITH VESSEL LOOPS. AN 8FR SHEATH WAS PLACED IN THE CFA, NEXT AN EXCHANGE LENGTH GLIDE WIRE WAS ADVANCED TO THE DESCENDING THORACIC AORTA. A MARKER OMNI FLUSH CATHETER WAS PLACED DISTAL TO THE LEFT SUBCLAVIAN; AN ANGIOGRAM WAS PERFORMED AND THE PROXIMAL AND DISTAL LANDING ZONES WERE IDENTIFIED AND ANOTHER MANUFACTURER¿S WIRE WAS ADVANCED TO THE LEVEL O

  Patient problems: Death; Perforation of Vessels

  MAUDE report 6234302 ↗