VALIANT® Captivia VAMF3232C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00643169347076), received between Feb 2, 2018 and May 15, 2024 — classified as 5 deaths, 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2024Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE RE-INTERVENTION FOR A PRIOR AORTIC REPAIR OF A THORACIC AORTIC DISSECTION ON (B)(6) 2019. THE PATIENT HAD AN EXISTING 3 TALENT STENT GRAFTS IMPLANTED APPROXIMATELY 10 YEARS PRIOR, 3 VALIANT CAPTIVIA IMPLANTED 7 YEARS PRIOR AND ENDURANT IIS STENT GRAFT SYSTEM STENT GRAFT IMPLANTED 6 MONTHS PRIOR TO THE IMPLANTATION OF THE VALIANT NAVION. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING TAKEN APPROXIMATELY 2 YEARS AND 5 MONTHS AFTER THE IMPLANTATION OF THE NAVION, SHOWED A TYPE LL ENDOLEAK AND A SUSPECTED FRACTURE ON MOST PROXIMAL NON-NAVION DEVICE; UNABLE TO CONFIRM AS UNKNOWN DEVICE AND UNKNOWN STENT RING DESIGN. THE MAX AORTIC DIAMETER WAS NOTED AS 65.9 MM. THE IMAGING WAS NA FOR AORTIC ENLARGEMENT. NO STENT FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED IN THE NAVION GRAFT.  THE CAUSE OF THE TYPE II ENDOLEAK AND SUSPECTED FRACTURE IS UNDETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PA TIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 19319779 ↗
• DeathMay 22, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE .  IT WAS REPORTED THROUGH DEVICE REGISTRATION, THAT THE PATIENT EXPIRED ON THE SAME DATE THE STENT GRAFTS WERE IMPLANTED.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 16972468 ↗
• MalfunctionFeb 13, 2023Leak/Splash; Obstruction of Flow; Leak/Splash; Obstruction of Flow

  A VALIANT CAPTVIA STENT GRAFT WAS INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A ULCER .  IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER OPENING THE DEVICE, THE PHYSICIAN THEN ATTEMPTED TO FLUSH THE SIDE PORT TO DE-AIR THE DEVICE BUT IT WOULD NOT FLUSH THROUGH. MULTIPLE ATTEMPTS WERE MADE   AND SMALLER SYRINGES WERE USED , BUT THE PHYSICIAN COULD NOT GET THE SALINE TO PASS.  A NEW DEVICE WAS OPENED  TO PROCEED WITH THE PROCEDURE. 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 16361571 ↗
• DeathJan 30, 2023Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A HEMORRHAGING PAU.  6 DAYS LATER, THE PATIENT WAS BROUGHT BACK TO THE OR FOR TREATMENT OF A SUSPECTED RUPTURE AT THE SAME SITE TREATED DURING THE INDEX PROCEDURE. THE PHYSICIAN DID IMPLANT A NON MDT STENT GRAFT AS TREATMENT BUT THE PATIENT EXPIRED.  THE CAUSE OF DEATH IS THE RUPTURED THORACIC AORTA. THE PHYSICIAN REPORTED THE THE RADIOLOGIST HAD REVIEWED THE SCANS THAT WERE PERFORMED  THE DAY OF THE INTERVENTION AND REPORTED THERE WAS A TYPE III ENDOLEAK. THE PHYSICIAN  SAID THAT DURING THE INTERVENTION PROCEDURE, AN ANGIOGRAM WAS PERFORMED AND THE PHYSICIAN DID NOT SEE ANY  LEAKS ON THE STENT GRAFT.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Rupture

  MAUDE report 16263002 ↗
• InjuryAug 24, 2022Fracture; Adverse Event Without Identified Device or Use Problem; Fracture; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR  TREATMENT OF A TAA. IT WAS REPORTED THAT DURING A CT PERFORMED APPROXIMATELY 7 YEARS AND 3 MONTHS POST INDEX PROCEDURE, A DISTAL STENT FRACTURE WAS NOTED. IT WAS SAID A PIECE HAD BROKE OFF.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions; Obstruction/Occlusion

  MAUDE report 15281956 ↗
• DeathApr 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED THAT THE PATIENTS SON CONTACTED TECHNICAL SERVICES WONDERING ABOUT HIS MOTHER GETTING AN ID CARD FROM MEDTRONIC? THE PATIENT'S SON STATED HE DID NOT KNOW HIS MOTHER HAD AN IMPLANT AND THAT SHE HAD PASSED 45 DAYS AGO. THE CAUSE OF DEATH WAS NOT PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 14191885 ↗
• InjuryMar 14, 2022Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 6 YEARS POST THE INDEX PROCEDURE, TWO VALIANT NAVION DEVICES WERE IMPLANTED DUE TO ADVANCED DISEASE PR OGRESSION. IT WAS FURTHER REPORTED THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 7 YEARS POST THE INDEX PROCEDURE WITH BACK AND SCAPULAR PAIN THAT HAD BEEN INCREASING OVER THE PREVIOUS MONTH. A CT REVEALED A LEFT HEMOTHORAX AND A 90MM THORACIC AORTIC ANEURYSM WITH CLEAR CONTRAST COMMUNICATION INTO THE ANEURYSM SAC. THE PATIENT WAS TRANSFERRED FOR TREATMENT OF THE ENLARGED ANEURYSM. DURING THE INTERVENTION THE PHYSICIAN NOTED THE ANEURYSM ENLARGEMENT WAS DUE TO SEPARATION BETWEEN SECONDARILY PLACED GRAFTS AND THE GRAFT WHICH WAS IMPLANTED DURING THE INDEX PROCEDURE (VNM3737C182TU DEVICE AND VAMF3232C100TU). THE PHYSICIAN IMPLANTED A VALIANT CAPTIVA DEVICE ACROSS THE DISUNION AND PLACED ANOTHER STENT GRAFT PROXIMALLY. THE ORDER OF DEVICES IMPLANTED ARE VNMC3737C182TU, VNMC3737C182TU AND VAMF3232C100TU. THE APPEARANCE OF THE STENT RING ENLARGEMENT WAS OBSERVED IN THE DISTAL VNM3737182 NAVION THAT HAD BEEN JOINED FROM THE EXISTING VALIANT CAPTIVA.

  Patient problems: Hemothorax; Pain

  MAUDE report 13755865 ↗
• DeathAug 31, 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 A 46 MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PATIENT'S BLOOD PRESSURE STARTED TO DROP DURING REMOVAL OF THE DELIVERY SYSTEM. THE BALLOON WAS PUT UP AGAIN TO GAIN CONTROL. PATIENT EXPIRED AT THE END OF PROCEDURE. IT WAS STATED THAT THE EXTERNAL ILIAC TORE DURING REMOVAL OF THE DELIVERY SYSTEM. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PATIENT'S ANATOMY DUE TO A VERY NARROW AND CALCIFIED LESION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 12391655 ↗
• MalfunctionMar 27, 2019Leak/Splash; Leak/Splash

  A VALIANT CAPTIVA STENT GRAFT WAS INTENDED FOR USE IN THE ENDOVASCULAR TREATMENT OF AN AORTIC TRANSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE DEVICE COULD NOT BE FLUSHED. A NEW DEVICE WAS USED SUCCESSFULLY TO COMPLETE THE PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DEVICE RELATED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8454991 ↗
• DeathFeb 2, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 31 MM DIAMETER 320 MM IN LENGTH THORACIC DISSECTION. IT WAS REPORTED THAT THE PATIENT PASSED AWAY POST OPERATIVELY. PER THE PHYSICIAN THE CAUSE OF DEATH WAS NOT DEVICE RELATED AND DUE IN PART TO COMPLICATIONS OF A CONNECTIVE TISSUE DISORDER THE PATIENT HAD A MEDICAL HISTORY OF. THE RESULTS FROM THE AUTOPSY REVEALED A RETROGRADE TYPE A DISSECTION (PREVIOUSLY NOT OBSERVED ON FINAL IMAGING DURING INDEX PROCEDURE) WITH PERICARDIAL HEMATOMA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Vascular Dissection

  MAUDE report 7237104 ↗