VALIANT® Captivia VAMF4646C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00643169347328), received between Oct 23, 2017 and May 26, 2025 — classified as 1 death, 1 injury, 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 26, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT A PATIENT UNDERWENT A THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) WITH A VALIANT CAPTIVIA STENT GRAFT TO TREAT A RUPTURED PAU. DURING A FOLLOW-UP COMPUTED TOMOGRAPHY, A TYPE IA ENDOLEAK WAS IDENTIFIED, ATTRIBUTED TO THE PATIENT'S ANATOMY. TO ADDRESS THE ENDOLEAK, FIVE ENDOANCHORS WERE PLACED. THE TREATMENT RESOLVED THE TYPE IA ENDOLEAK.

  Patient problems: Insufficient Information

  MAUDE report 22084140 ↗
• DeathOct 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF AN ACUTE DISSECTION. IT WAS REPORTED DURING THE INDEX PROCEDURE THAT FOLLOWING THE STENT GRAFT IMPLANT THAT THE PATIENT WENT INTO CARDIAC ARREST AND THE PATIENT PERFORMED COMPRESSIONS BUT THE PATIENT EXPIRED. THE PHYSICIAN REPORTED THAT THE DEATH WAS NOT ATTRIBUTED TO THE STENT GRAFT. IT WAS NOTED THAT THERE NO SALES REP PRESENT AT THE CASE DUE ITS URGENCY. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO ACUTE DISSECTION AND RUPTURE OF THE DESCENDING AORTA. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Cardiac Arrest; Vascular Dissection

  MAUDE report 12583302 ↗
• MalfunctionOct 23, 2017Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY IMPLANTED THE VALIANT STENT GRAFT ALONG WITH SUPERIOR MESENTERIC ARTERY (SMA) AND LEFT RENAL ARTERY WITH THE SNORKEL TECHNIQUE. THE PHYSICIAN MODELLED THE VALIANT STENT GRAFT WITH BALLOONING HOWEVER THE AORTOGRAM REVEALED A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO SNORKEL THE CELIAC ARTERY, LENGTHEN THE SMA STENT AND THE LEFT RENAL ARTERY STENT AND IMPLANTED A 2ND VALIANT STENT GRAFT HIGHER IN THE DESCENDING THORACIC AORTA. ALL DEVICES WERE PLACED SUCCESSFULLY. BALLOONING WAS COMPLETED HOWEVER THE AORTOGRAM REVEALED THAT THE TYPE IA ENDOLEAK WAS STILL PRESENT. PER THE PHYSICIAN, THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK WAS DUE TO THE PATIENT¿S ANATOMY, THORACOABDOMINAL ANEURYSM. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6967941 ↗