VALIANT® Captivia VAMF4238C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00643169400184), received between Mar 16, 2017 and Mar 28, 2023 — classified as 1 injury, 3 malfunctions.

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 18, 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.

• InjuryMar 28, 2023Adverse 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 A ULCER.   IT WAS REPORTED THAT DURING THE PROCEDURE, A NON MDT PLUG WAS USED TO OCCLUDE THE LEFT SUBCLAVIAN ARTERY TO FACILITATE THE PLACEMENT OF THE STENT GRAFT INTO ZONE 1. THE PLUG PARTIALLY COVERED THE LEFT VERTEBRAL ARTERY WHICH CAUSED THE PATIENT TO HAVE A STROKE. IT WAS SAID THE STENT GRAFT TREATED THE ULCER AND IS PERFORMING WELL. THE PATIENT IS RECEIVING STROKE TREATMENT PER HOSPITAL PROTOCOL.  PER THE PHYSICIAN THE CAUSE OF THE STROKE WAS THE NON MDT PLUG PARTIALLY COVERING THE LEFT VERTEBRAL ARTERY.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Stroke/CVA

  MAUDE report 16627855 ↗
• MalfunctionSep 6, 2021Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR TWO UNKNOWN ENDOVASCULAR TREATMENTS APPROX.. 4 YEARS 3 MONTHS POST THE INDEX PROCEDURE, THE PATIENT RETURNED FOR FOLLOW UP. A CT SHOWED MULTIPLE AREAS LEAKING INSIDE THE GRAFT. NO CAUSE OF THE EVENT WAS PROVIDED NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12427926 ↗
• MalfunctionOct 13, 2017Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED THORACIC DISSECTION. IT WAS REPORTED THAT AN IVUS CATHETER WAS ADVANCED AND THE DISSECTION AND FENESTRATION WERE VISUALIZED. THE PHYSICIAN OBTAINED CONTROLLED IVUS MEASUREMENTS THE PROXIMAL THORACIC AORTA WAS 42 MM IN DIAMETER. AN ANGIOGRAM WAS PREFORMED AND THE ARCH VESSELS WERE VISIBLE. DUE TO THE LOCATION OF THE DISSECTION THE PHYSICIAN LANDED THE PROXIMAL EDGE OF THE FIRST VALIANT STENT GRAFTDISTAL TO THE LEFT CAROTID ARTERY SUCCESSFULLY. ANOTHER ANGIOGRAM WAS PREFORMED TO SHOW THE ORIGIN OF THE CELIAC ARTERY. THE SECOND VALIANT STENT GRAFT WAS ADVANCED TO THE INTENDED LANDING ZONE, THE MAKERS WERE LINED UP AND THE VALIANT STENT GRAFT WAS IMPLANTED WITHOUT ISSUE, WITH THE DISTAL EDGE OF THE VALIANT STENT GRAFT LANDING SEVERAL CENTIMETERS PROXIMAL TO THE ORIGIN OF THE CELIAC ARTERY. A PIGTAIL CATHETER WAS ADVANCED THOUGH THE STENT GRAFT JUST PROXIMAL TO THE VALIANT STENT GRAFT FABRIC EDGE. THE FINAL ANGIOGRAM PREFORMED SHOWED THAT THE LEFT CAROTID AND THE LEFT SUBCLAVIAN ARTERIES WERE WIDELY PATENT, AND THE TYPE IB RUPTURED DISSECTION WASNO LONGER FILLING. HOWEVER, THERE

  Patient problems: No Consequences Or Impact To Patient; Vascular Dissection

  MAUDE report 6948089 ↗
• MalfunctionMar 16, 2017Break; Difficult To Position; Device Damaged by Another Device; Break; Difficult To Position; Device Damaged by Another Device

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS ATTEMPTED TO BE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 8 CM IN DIAMETER THORACIC AORTIC ANEURYSM. THE PATIENT HAD A PREVIOUSLY IMPLANTED BI-FEMORAL OPEN FABRIC SURGICAL GRAFT IMPLANTED APPROXIMATELY GREATER THAN 20 YEARS PRIOR TO THE PROCEDURE. A CT REVEALED THAT THE PREVIOUSLY IMPLANTED BI-FEMORAL STENT GRAFT WAS KINKED AND FOLDED IN DIFFERENT AREAS OF THE PATIENT¿S ANATOMY. THERE WAS NO THROMBUS OR CALCIFICATION AT THE PROXIMAL OR DISTAL IMPLANT SITE. THE VESSEL ACCESS DIAMETER WAS GREATER THAN 8 MM. IT WAS REPORTED THAT, DURING THE INDEX PROCEDURE, THE VALIANT STENT GRAFT DELIVERY SYSTEM WAS UNABLE TO ADVANCE THROUGH THE PREVIOUSLY IMPLANTED BI-FEMORAL SURGICAL GRAFT. THE PHYSICIAN ELECTED TO USE SEQUENTIAL DILATORS, INCLUDING A 22 FR DILATOR, BUT THE VALIANT DELIVERY SYSTEM STILL COULD NOT BE ADVANCED THROUGH THE PREVIOUSLY IMPLANTED BI-FEMORAL SURGICAL GRAFT. A BUDDY WIRE TECHNIQUE AND EXTERNAL MANIPULATION WERE ATTEMPTED BUT THE VALIANT DELIVERY SYSTEM STILL COULD NOT BE ADVANCED. THE PHYSICIAN ELECTED TO REPLACE THE VALIANT DEVICE WITH A SMALLER PROFILE VALIANT DELIVERY SYSTEM AND THE DELIVERY SYSTEM WAS ABLE T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6411936 ↗