VALIANT® Captivia VAMC4646C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169346802), received between May 15, 2018 and Oct 23, 2018 — classified as 3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A HELI-FX ENDOANCHORING SYSTEM WAS USED IN A PATIENT FOR THE THORACIC ENDOVASCULAR TREATMENT OF A TYPE IA AND IB ENDOLEAK AND MIGRATION OF A VALIANT STENT GRAFT SYSTEM. A VALIANT DISTAL STENT GRAFT EXTENSION WAS ALSO IMPLANTED DURING THE PROCEDURE. IT WAS REPORTED RIGHT AFTER THE INDEX PROCEDURE THE PATIENT DEVELOPED FRANK HEMATURIA. AN IRRIGATION PROCEDURE WAS PERFORMED WHICH REMOVED SOME SMALL CLOTS. THE EVENT REMAINS UNRESOLVED BUT CONTINUING WITHOUT TREATMENT AND THE PATIENT WAS DISCHARGED FROM HOSPITAL TWO DAYS LATER. PER THE INVESTIGATOR THE CAUSE OF THE HEMATURIA IS RELATED TO THE INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT BE MONITORED.

  Patient problems: Hematuria; Injury

  MAUDE report 7994593 ↗
• InjuryAug 17, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 50MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, CT SHOWED A TYPE IB ENDOLEAK, 20MM ABOVE THE CELIAC ARTERY. INTERVENTION WAS PERFORMED ON THE SAME DAY AND THE PATIENT RECEIVED A VALIANT 46MM DISTAL EXTENSION. THE ENDOLEAK WAS CONFIRMED RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7792828 ↗
• InjuryJun 15, 2018Activation, Positioning or Separation Problem; Device Dislodged or Dislocated; Activation, Positioning or Separation Problem; Device Dislodged or Dislocated

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE STENT GRAFT WAS DEPLOYED DURING THE PROCEDURE AND THE DELIVERY SYSTEM RECAPTURED CORRECTLY AS SEEN UNDER FLUOROSCOPY. IT WAS REPORTED THE STENT GRAFT HAD NO MOVEMENT AND DID NOT COME DOWN WHILE RECAPTURING THE DELIVERY SYSTEM. AFTER RE-CAPTURE THE DELIVERY SYSTEM WAS BROUGHT DOWN INTO THE ABDOMINAL AORTA. THE PHYSICIAN REPORTED THAT FLUOROSCOPY WAS NOT USED FOR THIS AS THE STEP WAS JUST TO BRING THE DELIVERY SYSTEM WITHIN THE ABDOMINAL AORTA. IT WAS REPORTED THE DISTAL END OF THE STENT GRAFT BECAME CAUGHT WITH THE DELIVERY SYSTEM AND THE GRAFT WAS PULLED DOWN BELOW THE CELIAC AND SUPERIOR MESENTERIC ARTERY. THIS WAS SEEN WHEN FLUOROSCOPY WAS TURNED BACK ON. TWO NON-MDT STENTS WERE USED TO PROVIDE A SHUNT IN ORDER TO KEEP THE CELIAC AND SUPERIOR MESENTERIC ARTERY PERFUSED. IT WAS REPORTED THE PHYSICIAN THEN DECIDED TO PERFORM A THORACOTOMY AND EXPLANT THE VALIANT STENT GRAFT. THIS WAS SUCCESSFULLY COMPLETED, AND ANOTHER VALIANT STENT GRAFT WAS THEN IMPLANTED SUCCESSFULLY. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED

  Patient problems: Injury

  MAUDE report 7605847 ↗
• MalfunctionMay 15, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 56MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS PLANNED THAT HELI-FX ENDOANCHORS WOULD ALSO BE USED PROPHYLACTICALLY IN THE PROCEDURE DUE TO CONCERN OVER A SHORT DISTAL LANDING ZONE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE FIRST VALIANT STENT GRAFT WAS PLACED IN A STRAIGHT SEGMENT OF THE THORACIC AORTA AND DEPLOYED WITHOUT ISSUE. A SECOND VALIANT STENT GRAFT WAS THEN DEPLOYED PROXIMAL TO THE CELIAC TRUNK WITHOUT ISSUE. A RELIANT BALLOON WAS USED TO SEAL THE PROXIMAL, OVERLAP AND DISTAL SEAL ZONES. THEN A TOTAL OF 8 ENDOANCHORS WERE PLACED IN THE DISTAL SEAL ZONE AND AN ANGIOGRAM WAS PREFORMED THAT SHOWED A TYPE IB ENDOLEAK. THE PHYSICIAN RE-BALLOONED THE DISTAL SEAL MORE AGGRESSIVELY AND THIS SHOWED THE TYPE IB ENDOLEAK WAS GREATLY REDUCED. THE PHYSICIAN DECIDED TO END THE PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO THE SHORT DISTAL SEAL ZONE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7514257 ↗