VALIANT® Captivia VAMF3030C200TURecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00643169346901), received between Mar 9, 2017 and Jun 20, 2025 — classified as 1 death, 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (5 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 20, 2025Leak/Splash; Leak/Splash

  TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN ACUTE TYPE B DISSECTION VAMF3030C200TU WAS IMPLANTED PROXIMALLY FOLLOWED BY VAMF3232C200TU. 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 22296157 ↗
• MalfunctionMay 27, 2024Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT ((B)(6)) WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC INTRAMURAL HEMATOMA. IT WAS REPORTED DURING THE INDEX PROCEDURE, DURING PREP OF THE DELIVERY SYSTEM, FLUSHING OF THE GRAFT COVER WAS EXTREMELY DIFFICULT AND THE TEAM WERE UNABLE TO FLUSH AIR FROM THE GRAFT COVER ADEQUATELY. NO OBSTRUCTION WAS OBSERVED. THERE WAS NO DAMAGE NOTED TO THE DEVICE OR DEVICE PACKAGING. AND THE DEVICE WAS NOT IN CONTACT WITH THE PATIENT. A REPLACEMENT DEVICE OF THE SAME SIZE WAS USED AND IMPLANTED SUCCESSFULLY PER THE PHYSICIAN THE CAUSE OF THE INABILITY TO FLUSH THE DELIVERY SYSTEM IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED, AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19400369 ↗
• InjuryJun 30, 2023Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AORTIC TRANSECTION. IT WAS REPORTED THAT DURING THE PROCEDURE, THE STENT GRAFT WAS DELIVERED WITHOUT ISSUE AND DEPLOYED, THE PHYSICIAN BEGAN TO TRY TO RELEASE THE TIP CAPTURE MECHANISM TO DEPLOY THE BARE METAL STENTS BUT IT DID NOT DEPLOY. THE PHYSICIAN TRIED AGAIN BUT WITH NO SUCCESS. THE STIFF WIRE WAS PULLED BACK AND THE TIP CAPTURE WAS TRIED AGAIN BUT IT STILL DID NOT WORK.  THE TIP CAPTURE DELIVERED SYSTEM WAS REMOVED AND AN ATTEMPT TO MANUALLY REMOVE THE TIP CAPTURE WAS ATTEMPTED BUT THE MANUAL RELEASE WAS STUCK AND IT WOULD NOT RELEASE. AFTER A FEW MORE ATTEMPTS , THE BARE METAL STENTS RELEASED. WHEN REMOVING THE DELIVERY SYSTEM FROM THE PATIENT, THE DELIVERY SYSTEM BECAME STUCK IN THE COMMON FEMORAL ARTERY AND A CUT DOWN WAS REQUIRED TO REMOVE THE DELIVERY SYSTEM SUCCESSFULLY.  PER THE PHYSICIAN THE CAUSE OF THE DEPLOYMENT ISSUE WAS THAT THE DELIVERY SYSTEM DID NOT PERFORM AS EXPECTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17236928 ↗
• DeathAug 16, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; 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 A FOLLOW UP CT A TYPE IA ENDOLEAK WAS IDENTIFIED ON DEVICE VAMF3030C200 ((B)(4)). 2 2 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 NOEVIDENCE 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 POSSI

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 15232328 ↗
• InjurySep 2, 2021Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA THORACIC STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 200MM DISSECTION. ON (B)(6) 2021 IT WAS REPORTED THAT AN UNKNOWN ENDOLEAK WAS OBSERVED DURING A FOLLOW UP CT SCAN.  AN INTERVENTION WAS PERFORMED ON THE (B)(6) 2021 WHERE ANOTHER STENT GRAFT WAS IMPLANTED IN THE PATIENT. THE REPORTED ENDOLEAK HAS RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12414086 ↗
• InjuryFeb 18, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSM. A VALIANT STENT GRAFT WAS ALSO IMPLANTED IN THE PATIENT APPROXIMATELY ONE MONTH LATER. IT WAS REPORTED A FOLLOW UP CT IDENTIFIED THORACOABDOMINAL ANEURYSM ENLARGEMENT AND A DISSECTION. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS DISEASE PROGRESSION. TWO ENDURANT LIMBS ETLW1616C93 AND ETLW1616C156E WERE IMPLANTED IN THE PATIENT DURING AN INTERVENTION PROCEDURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm; Intimal Dissection

  MAUDE report 8347016 ↗
• InjuryMay 25, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE FOLLOW-UP CT SHOWED A DISTAL TYPE 1 ENDOLEAK. THE PHYSICIAN ELECTED TO EXTEND COVERAGE BY IMPLANTING ANOTHER VALIANT STENT GRAFT AND THE EVENT WAS RESOLVED. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS ANATOMY RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6592886 ↗
• InjuryMar 9, 2017Malposition of Device; Malposition of Device

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 280 MM THORACIC AORTA TYPE B DISSECTION. DEPLOYMENT OF THORACIC GRAFTS WAS SUCCESSFUL LANDING JUST DISTAL TO LEFT COMMON CAROTID ARTERY. IT WAS REPORTED THAT AFTER THE VALIANT STENT GRAFT HAD LASER FENESTRATION PERFORMED FOR ACCESS TO THE LEFT SUBCLAVIAN ARTERY A COMPLETION ANGIOGRAM WAS PERFORMED DEMONSTRATING THAT THE VALIANT STENT GRAFT HAD PARTIALLY ENCROACHED THE LEFT COMMON CAROTID ARTERY. AN ATTEMPT WAS MADE TO PULL THE PROXIMAL PORTION OF THE VALIANT STENT GRAFT BACK SLIGHTLY BY USE OF BALLOON BUT WAS UNSUCCESSFUL. THE PHYSICIAN MADE THE DECISION TO STENT THE LEFT COMMON CAROTID WITH ANOTHER MANUFACTURER¿S 8 X 27 MM BALLOON EXPANDABLE STENT TO ALLEVIATE ENCROACHMENT. THE LEFT COMMON CAROTID WAS CANNULATED AND SUCCESSFULLY STENTED. A COMPLETION ANGIOGRAM SHOWED GROSS PATENCY OF THE ORIGIN OF THE LEFT COMMON CAROTID. PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Occlusion

  MAUDE report 6392468 ↗