VALIANT® Captivia VAMF3232C200TURecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00643169347137), received between Nov 30, 2016 and Jul 25, 2025 — classified as 2 deaths, 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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.

• MalfunctionJul 25, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE TO TREAT AN AORTIC DISSECTION MEASURING OVER 400MM IN LENGTH, THE STENT GRAFT VAMF32 32C200TU VALCAP FREFL DELIVERY SYSTEM BECAME STUCK DURING DEPLOYMENT AND THE STENT COULD NOT BE DEPLOYED. WHILE THE PHYSICIAN WAS INITIALLY ABLE TO ROTATE THE BLUE DEPLOYMENT WHEEL AND RETRACT THE SHEATH UP TO THE LEVEL OF THE BARE METAL STENTS, THE DEVICE SUBSEQUENTLY BECAME STUCK AND THE WHEEL WOULD NO LONGER TURN, AND THE SHEATH FAILED TO RETRACT. ATTEMPTS TO REVERSE THE WHEEL¿S DIRECTION IN ORDER TO FREE THE MECHANISM WERE UNSUCCESSFUL. AS A RESULT, THE DEVICE COULD NOT BE DEPLOYED AS INTENDED AND WAS REMOVED FROM THE PATIENT. A MANUFACTURING ISSUE WAS REPORTED AS THE CAUSE OF THE DEVICE MALFUNCTION BY THE PHYSICIAN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING A REPLACEMENT STENT GRAFT (VAMF3232C150TU, (B)(6), AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22607317 ↗
• InjuryJun 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ACUTE TYPE B DISSECTION (B)(6) WAS IMPLANTED PROXIMALLY FOLLOWED BY (B)(6). A TYPE IA ENDOLEAK WAS NOTED DURING THE INDEX PROCEDURE WHICH WAS LEFT UNCORRECTED. IT WAS REPORTED THAT APPROXIMATELY 6 WEEKS POST IMPLANT THE PATIENT RETURNED FOR FOLLOW-UP AND ON A CT A RETROGRADE TYPE A DISSECTION WAS DISCOVERED IN ZONE 2. INTERVENTION WAS PERFORMED WITH REPLACEMENT OF THE ASCENDING AORTA AND TRANSVERSE ARCH WITH CONNECTION INTO THE TEVAR. THE PATIENT WAS DISCHARGED APPROXIMATELY 3 WEEKS LATER. THE SITE ASSESSED THE DISSECTION AS POSSIBLY RELATED TO THE STUDY DEVICE AND PROBABLY RELATED TO THE STUDY PROCEDURE. THE SPONSOR ASSESSED THE DISSECTION AS POSSIBLY RELATED TO THE PROCEDURE AND NOT RELATED TO THE DEVICE.

  Patient problems: Vascular Dissection

  MAUDE report 22296160 ↗
• DeathAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA DEVICES WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE . IT WAS REPORTED ABOUT 7 WEEKS LATER FOLLOW UP CT A TYPE IA ENDOLEAK WAS IDENTIFIED ON DEVICE VAMF3030C200 ((B)(4)). VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED WITH NO ISSUE TO REPAIR THE TYPE IA ENDOLEAK. THE PHYSICIAN WANTED TO DO A LASER FENESTRATION OF THE LEFT SUBCLAVIAN ARTERY. THE GRAFT WAS PLACED AT THE LEVEL OF THE LEFT CAROTID ARTERY AND BALLOONED WITH A RELIANT TO THE APPROPRIATE DIAMETER. THE PHYSICIAN HAD A DIFFICULT TIME WITH LASER FENESTRATION OF THE LSA WITH MULTIPLE ATTEMPTS MADE BUT IT WAS UNCERTAIN IF THE PHYSICIAN WAS INSIDE OF THE VALIANT GRAFT. ANESTHESIA STATED THAT THE PATIENT'S CONDITION WAS NOT DOING WELL. THE PHYSICIAN DECIDED TO DO AN ANGIOGRAM WHERE NO TYPE A DISSECTION (ASCENDING) AND NO EXTRAVASATION IN THE THORACIC AORTA WAS SEEN. IVUS WAS LOOKED AT WITH NO EVIDENCE OF RUPTURE OR DISSECTION. CPR WAS INITIATED FOR A PERIOD OF TIME. ANESTHESIA DID A TEE AND SAW A PERICARDIAL EFFUSION AND BLOOD IN THE CHEST. THE PHYSICIAN PUT IN A CHEST TUBE AND CHEST COMPRESSION CONTINUED TO NO AVAIL. A RELIANT BALLOON WAS INFLATED TO TAMPONADE THE AORTA IN THE ARCH TO SEE IF POSSIBL

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 15232308 ↗
• MalfunctionJul 23, 2021Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED PRIOR TO THE PROCEDURE, WHILE PREPARING THE DEVICE, IT WAS NOTED TO BE DIFFICULT TO FLUSH, AND THE SALINE WAS NOT COMING OUT BY THE GRAFT COVERING. THE DEVICE WAS PROPERLY FLUSHED THROUGH THE END WIRE PORT AND THE TIP WAS POINTED STRAIGHT UP WHILE FLUSHING. DURING FLUSHING OF THE SIDE PORT THE TECHNICIAN FLUSHED BUT THE SALINE DIDN'T COME OUT THE END OF THE GRAFT COVERING. MORE SALINE WAS USED TO PUSH THROUGH BUT ONLY HAD BACK PRESSURE. IT WAS THEN REPORTED THAT THE TECHNICIAN WAS DIRECTED TO SLIGHTLY DEPLOY THE GRAFT COVERING AND THEN CONTINUE TO FLUSH AND THIS EVENTUALLY WORKED. THE GRAFT COVERING WAS THEN REMATED AND DEVICE WAS USED FOR PROCEDURE AND DEPLOYED WITHOUT ANY COMPLICATIONS. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12216152 ↗
• InjuryFeb 28, 2020Device Damaged by Another Device; Device Damaged by Another Device

  TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 57MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW-UP 3 YEARS AND 3 MONTHS LATER, A CT WAS PERFORMED WHERE CONTRAST IN THE SAC WAS PRESENT. INITIALLY IT WAS UNCLEAR WHETHER IT WAS A TYPE II OR TYPE III ENDOLEAK. A DIAGNOSTIC ANGIOGRAM WAS PERFORMED ON THE SAME DATE AND THE ENDOLEAK WAS CONFIRMED TO BE A TYPE IIIB GRAFT DEFECT. AS PER THE PHYSICIAN IT WAS BELIEVED THAT THE BARE STENT OF THE 32MM DISTAL COMPONENT HAS ERODED THROUGH THE FABRIC OF THE 36MM PROXIMAL COMPONENT. THERE WAS NO CHANGE IN ANEURYSM SAC DIAMETER SINCE INITIAL IMPLANT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS FRICTION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 9768576 ↗
• InjuryAug 25, 2017Leak/Splash; Leak/Splash

  AN VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 25.0 CM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT A TYPE IB ENDOLEAK WAS DISCOVERED. THE PATIENT HAD A DISTAL EXTENSION PLACED ON WITH VISCERAL STENTING (CELIAC, LEFT RENAL, AND SMA). PER THE PHYSICIAN, THE CAUSE OF THE ENDOLEAK WAS DUE TO THE PATIENT ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6819815 ↗
• DeathMay 25, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED FOR AN ENDOVASCULAR TREATMENT. IT WAS ORIGINALLY BELIEVED THAT THE PATIENT HAD A PENETRATING ATHEROSCLEROTIC ULCER. HOWEVER, INTRAVASCULAR ULTRASOUND REVEALED THAT IT WAS A DISSECTION. DURING THE INDEX PROCEDURE, AFTER THE VALIANT STENT GRAFT WAS IMPLANTED, THE PATIENT¿S RIGHT RADIAL ARTERIAL LINE PRESSURE DECREASED. THE LEFT ARM CUFF PRESSURE WAS NORMAL. AN ANGIOGRAM REVEALED THAT THERE WAS A RETROGRADE TYPE A DISSECTION THAT EXTENDED TO THE AORTIC VALVE. THE PHYSICIAN ELECTED TO CONVERT THE PATIENT TO OPEN REPAIR OF THE ASCENDING ARCH. THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS FOR 1.5 HOURS AFTER THE VALIANT STENT GRAFT HAD BEEN DEPLOYED. DURING THE OPEN REPAIR, IT WAS NOTED THAT THE ENTRY TEAR WAS NOT NEAR THE BARE STENTS OF THE VALIANT STENT GRAFT AND THE TEAR DID NOT APPEAR TO HAVE BEEN CAUSED BY THE DEVICE. THE PHYSICIAN NOTED THAT THE PATIENT¿S TISSUE WAS VERY THIN AND IT MADE IT DIFFICULT TO SEW. THE PHYSICIAN NOTED THAT THE INNOMINATE ARTERY WAS REMOVED FROM THE AORTA BY JUST USING A FINGER AND THAT IT WASN'T NORMAL TO BE ABLE TO DO THAT. AFTER THE GRAFT WAS PLACED AND SEWN TOGETHER, THE PATIENT WAS UNABLE TO BE WEANED OF

  Patient problems: Death; Vascular Dissection

  MAUDE report 6592975 ↗
• InjuryMar 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF 300 MM IN LENGTH THORACIC DISSECTION. IT WAS REPORTED THAT THE PATIENT HAD POST-OPERATIVE ISSUES. IT WAS REPORTED THAT FOUR DAYS POST INDEX PROCEDURE THE PATIENT HAD CODED AND WAS RESUSCITATED AND HAS BEEN HAVING HEART PROBLEMS, MAINTAINING THEIR HEART RATE AND CARDIAC OUTPUT. TWO OR THREE DAYS LATER THE PATIENT HAD PARALYSIS IN THEIR LEGS AND FEET. THE PHYSICIAN BELIEVES THAT WHEN THE PATIENT¿S HEART WAS UNSTABLE, THE CARDIAC OUTPUT DROPPED, WHICH INFARCTED THE SPINAL CORD, RESULTING IN THE PARALYSIS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Ischemia; Myocardial Infarction; Paralysis

  MAUDE report 6421643 ↗
• MalfunctionNov 30, 2016Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60 MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY ONE MONTH POST INDEX PROCEDURE A CT REVEALED THAT THE VALIANT STENT GRAFT HAD A PROXIMAL TYPE I ENDOLEAK. NO TREATMENT WAS PERFORMED AND THE EVENT WAS NOT RESOLVED. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO THE PATIENT ANATOMY OF AN ANGULATED AORTIC NECK.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6136916 ↗