VALIANT® Captivia VAMF4646C200TURecalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169346512), received between Dec 5, 2016 and May 13, 2026 — classified as 3 deaths, 6 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (7 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING AN INDEX PROCEDURE TO TREAT AN AORTIC ULCER, A DEPLOYMENT ISSUE OCCURRED WITH A VALIANT CAPTIVIA STENT GRAFT. NO ISSUES WERE FOUND ON THE DEVICE DURING INSPECTION PRIOR TO USE AND THE INSTRUCTIONS FOR USE WERE FOLLOWED DURING PREPARATION AND DEPLOYMENT ATTEMPT. DURING THE PROCEDURE, THE DELIVERY SYSTEM WAS ADVANCED INTO THE THORACIC AORTA AND POSITIONED BETWEEN THE LEFT CAROTID ARTERY AND THE LEFT SUBCLAVIAN ARTERY. THE DEVICE REMAINED IN THE THORACIC AORTA FOR APPROXIMATELY 10-15 MINUTES PRIOR TO DEPLOYMENT WHILE THE CLINICAL TEAM ADDRESSED ISSUES WITH THE POWER INJECTOR. ONCE THE INJECTOR WAS FIXED, THE SURGEON PERFORMED AN ANGIOGRAPHIC RUN AND MARKED THE INTENDED LANDING ZONE. WHEN THE DEPLOYMENT BEGAN, SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHILE TURNING THE BLUE DEPLOYMENT HANDLE. INCREASING DIFFICULTY WAS ENCOUNTERED WHEN ROTATING THE HANDLE AND THE SHEATH DID NOT RETRACT AS EXPECTED. THE SHEATH MAY HAVE RETRACTED APPROXIMATELY ONE TO TWO INCHES. THE PHYSICIAN THEN ATTEMPTED TO PULL THE GRAY TRIGGER ON THE DELIVERY SYSTEM BUT ALSO EXPERIENCED SIGNIFICANT DIFFICULTY. THE DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT AND A DIFFERENT MEDTRONIC DEVICE W

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25158125 ↗
• MalfunctionMar 18, 2026Nonstandard Device; Positioning Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE FOR TREATMENT OF A THORACIC AORTIC ANEURYSM MEASURING 7.6 CM, THE STENT GRAFT VAMF46 46C200TU VALCAP FREFL WAS UNABLE TO BE PASSED FAR ENOUGH UP TO REACH THE MINIMAL OVERLAP MARKER AFTER  SUCCESSFUL DEPLOYMENT OF THE 42-38-150 PROXIMAL DEVICE. IT ADVANCED A LONG WAY BUT ONCE IT WAS NEAR THE CURVE THE DEVICE ADVANCED INTO THE APEX BUT WAS NOT ABLE TO BE ADVANCED FAR ENOUGH TO REACH THE MINIMUM OVERLAP MARKER ON THE PROXIMAL PIECE. MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE VAMF4646C200TU, BUT A GAP IN THE DEVICE WAS OBSERVED, WHICH WAS BELIEVED TO CAUSE THE INABILITY TO CROSS. THE DEVICE WAS SUBSEQUENTLY REMOVED. THE PATIENT WAS TREATED WITH OTHER DEVICES THAT WERE SHORTER IN LENGTH, WHICH WERE ABLE TO TRACK MORE EASILY. THE PATIENT WAS TREATED FOR THE ANEURYSM AND THERE WAS NO INCIDENT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE CAUSE OF THE EVENT WAS NOT DETERMINED. IT WAS NOTED THAT THE NORMAL GAP OF A FEW MILLIMETERS BETWEEN THE NOSE CONE WAS OBSERVED BEFORE INSERTION BUT THERE WAS NO VISIBLE DAMAGE TO THE DEVICE. THE PHYSICIAN FELT THAT THE SMALL GAP OF THE DEVICE WAS AWAY FROM THE NOSE CONE CAUSED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24629961 ↗
• InjuryFeb 26, 2026Nonstandard Device; Positioning Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE TO TREAT A 55 MM ANEURYSM, WHEN VALIANT CAPTIVIA WAS REMOVED FROM THE BOX, THE TIP OF THE GRAFT COVER OF THE VALIANT CAPTIVIA STENT GRAFT DEVICE WAS NOT SMOOTHLY TRANSITIONED TO THE NOSE AND A GAP WAS OBSERVED. THE PHYSICIAN NOTED VERY TIGHT ACCESS IN THIS CASE AND EXPRESSED CONCERN THAT THE SHARP EDGE OF THE GRAFT COVER POTENTIALLY DUG INTO THE INTIMA OF THE ARTERY. TISSUE WAS OBSERVED STUCK INSIDE THE GRAFT COVER. ONE DEVICE WAS ABLE TO BE IMPLANTED, THE SECOND PROXIMAL DEVICE WAS UNABLE TO PASS THROUGH THE PATIENT ARTERY AND ENTIRE PROCEDURE WAS UNABLE TO BE FINISHED. FUTURE TREATMENT IS POSSIBLY PLANNED TO COMPLETE THE PROCEDURE. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Vascular Dissection

  MAUDE report 24454878 ↗
• InjuryJul 15, 2024Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA .  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY. A IB ENDOLEAK WAS NOTED AND THE TAA MEASURED 80MM. A ENDOVASCULAR REPAIR WITH SURGICAL DEBRANCHING WAS PERFORMED AS TREATMENT. THE ENDOLEAK RESOLVED.  PER THE PHYSICIAN THE CAUSE OF THE IB ENDOLEAK WAS DISEASE PROGRESSION.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 19738534 ↗
• DeathNov 18, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA AND ENDURANT STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 58 MM THORACIC ANEURYSM. IT WAS REPORTED DURING THE INDEX PROCEDURE, VAMF4646C200TU WAS ADVANCED TO THE THORACIC AORTA WITH SOME RESISTANCE BUT PLACED SUCCESSFULLY. UPON REMOVAL OF THE DELIVERY SYSTEM, FEMORAL ARTERY TISSUE WAS SEEN ON THE DELIVERY CATHETER. A 20FR SHEATH WAS INSERTED AND BLOOD PRESSURE WAS STABLE FOR A MOMENT AND THEN DROPPED SO BALLOON OCCLUSION WAS PERFORMED. DUE TO RIGHT ILIOFEMORAL ARTERY DAMAGE/EVULSION THE PHYSICIANS ELECTED TO DIRECT FLOW FROM THE ABDOMINAL AORTA TO THE RIGHT FEMORAL HEAD THROUGH THE AREA OF THE INJURY WITH AND ENDURANT 23 MM AUI AND 10 MM LIMBS TO BE FOLLOWED WITH A RIGHT TO LEFT FEM- FEM GRAFT . ONCE THE AUI AND LIMBS WERE IN PLACE, BALLOON OCCLUSION WAS RELEASED. THE PATIENTS BP CONTINUED TO DROP AND A RETROGRADE ANGIOGRAM THE RIGHT REVEALED A DISUNION BETWEEN ETLW16010C124E AND ETEW1010C82E. BALLOON OCCLUSION WAS ESTABLISHED VIA THE LEFT SIDE (BEHIND THE AUI). IN ORDER TO MAINTAIN BP WHILE WORKING ON THE RIGHT. AN ETEW1313C82E WAS PLACED TO BRIDGE THE ENDURANT LIMBS WITH A NON MDT 12 MM X 38 MM COVERED STENT TO SECURE IT. BALLOON OCCLUSION I

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 15824254 ↗
• InjurySep 7, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING INTERVENTION OF A TYPE IA ENDOLEAK PRESENT IN A PREVIOUSLY IMPLANTED NAVION STENT GRAFT AFTER THE PATIENT PRESENTED EMERGENTLY WITH SEVERE CHEST PAIN ON (B)(6) 2021. A PROCEDURE TO DEBRANCH THE PROXIMAL AORTA WAS PERFORMED. THE PATIENT WAS TAKEN TO THE OR WHERE A GRAFT WAS PLACED ON THE PROXIMAL ASCENDING ARCH TO THE GREAT VESSELS. AFTER THAT PROCEDURE THE PATIENT WAS TRANSFERRED TO THE HYBRID LAB WHERE THE PHYSICIAN PLACED A 46X46X200 VALIANT DOWN THE ASCENDING LANDING DOWN TO THE BYPASS. THE DISTAL END OF THE GRAFT LANDED IN THE MID PORTION OF THE PREVIOUS IMPLANTED DEVICES. THE POST ANGIOGRAM SHOWED NO ENDOLEAK. THE PROCEDURE WAS COMPLETED AND THE PATIENT WAS REMOVED FROM THE OR. *DURING THE ORIGINAL INDEX PROCEDURE ON (B)(6) 2019 A NAVION STENT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A RUPTURED THORACIC AORTIC ANEURYSM. ON (B)(6) 2021 AN ADDITIONAL NAVION STENT GRAFT WAS IMPLANTED PROXIMALLY DURING INTERVENTION FOR A SUSPECTED TYPE IIIB/IA ENDOLEAK AND ANEURYSM ENLARGEMENT(50MM-70MM) AND SUSPTECTED STENT RING ENLARGEMENT IN A DIFFERENT AREA OF THE GRAFT AND IT APPEARED LIKE THE STENT HAD COME OFF THE GRAFT. THE PATIENT HA

  Patient problems: Hemothorax; Insufficient Information

  MAUDE report 12431933 ↗
• 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 12427914 ↗
• InjuryMay 13, 2019Leak/Splash; Leak/Splash

  TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. A THIRD VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED. IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE, A TYPE IIIA ENDOLEAK WAS SUSPECTED. THE PATIENT THEN CODED WHILE EN-ROUTE FOR TREATMENT OF THE ENDOLEAK AND OCCLUSION OF ALL THREE VALIANT CAPTIVIA STENT GRAFTS WAS REPORTED PER THE PHYSICIAN. VISUALIZATION COULD NOT BE ACHIEVED DUE TO THE OCCLUSIONS, AND SO IT COULD NOT BE DETERMINED WHICH DEVICES HAD THE TYPE IIIA ENDOLEAK. AN ATTEMPT WAS MADE TO TREAT THE OCCLUSIONS, HOWEVER THIS WAS UNSUCCESSFUL. THE PHYSICIAN WAS UNABLE TO PASS A GUIDEWIRE INTO THE STENT GRAFTS DUE TO THE OCCLUSIONS. THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Myocardial Infarction; Occlusion

  MAUDE report 8603779 ↗
• DeathNov 28, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTIC ANEURYSM. THE DIAMETER CAUDAL TO THE LEFT CAUDAL ARTERY WAS 34.0/34.9MM AND DIAMETER CAUDAL TO THE LEFT SUBCLAVIAN ARTERY 31.7/34.9MM. IT WAS REPORTED THAT THE PATIENT PRESENTED APPROXIMATELY 16 MONTHS POST INDEX PROCEDURE WITH A TYPE I ENDOLEAK. DURING A RE-INTERVENTION THE STENT GRAFT WAS EXTENDED PROXIMALLY AND BALLOONED HOWEVER, IT WAS NOTED THAT THERE WAS A BLUSH AT THE END OF THE CASE INDICATING THE ENDOLEAK WAS STILL PRESENT. A SCAN WAS DONE FEW DAYS LATER THAT SHOWED AN ENDOLEAK STILL PRESENT; HOWEVER, IT WAS REPORTED THAT THE PATIENT DIED 2 MONTHS LATER AND THE PHYSICIAN STATED THE CAUSE OF DEATH WAS DUE TO AN MI. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Myocardial Infarction

  MAUDE report 7062650 ↗
• InjuryJul 13, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 71MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT WAS PARALYZED ON AN UNKNOWN DATE AFTER THE INITIAL PROCEDURE. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT IS UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Low Blood Pressure/ Hypotension; Paralysis

  MAUDE report 6711093 ↗
• MalfunctionApr 13, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.3 CM IN DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE DEPLOYMENT OF THE VALIANT STENT GRAFT, THE PHYSICIAN WAS TURNING THE BLUE PORTION OF DEPLOYMENT HANDLE AND THERE WAS A CLICKING SOUND AND PERIODICALLY STICKING/CATCHING DURING ROTATION. THE VALIANT STENT GRAFT WAS SUCCESSFULLY DEPLOYED AT THE INTENDED LANDING ZONE. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6492283 ↗
• DeathMar 16, 2017Adverse 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 7.2 CM IN DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT POST INDEX PROCEDURE, THE PATIENT HAD A LOW PLATELET COUNT AND THE SPINAL DRAIN HAD NOT BEEN REMOVED. THE PATIENT WAS GETTING PLATELETS. THE PATIENT WAS ALERT AND ORIENTED. APPROXIMATELY, TEN DAYS LATER THE PATIENT FELT LIKE THEY HAD TO BELCH. TWELVE DAYS LATER THE PATIENT COLLAPSED AND DIED. PER THE PHYSICIAN THEY FELT IT WAS THE RESULT OF A PULMONARY EMBOLISM. THE FAMILY REFUSED TO HAVE AN AUTOPSY PERFORMED. PER THE PHYSICIAN, THE EVENT WAS NOT RELATED TO THE DEVICE BUT MAY HAVE BEEN RELATED TO THE PROCEDURE OR TO THE HOSPITAL STAY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Pulmonary Embolism

  MAUDE report 6412014 ↗
• InjuryDec 5, 2016Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT A RUPTURED 6 CM IN DIAMETER THORACIC AORTIC ANEURYSM. THE PATIENT¿S ANATOMY WAS SEVERELY DISEASED. THE VALIANT STENT GRAFT WAS IMPLANTED. IT WAS REPORTED THAT THERE WAS NO DISTAL THORACIC AORTIC NECK SEAL/LANDING ZONE, (DUE TO THE LARGE DIAMETER), AND THE PHYSICIAN STATED THAT THERE WAS NO OTHER OPTION BUT TO COVER THE CELIAC ARTERY, AS A LIFE SAVING MEASURE. THE FINAL ANGIOGRAM REVEALED THAT THERE WAS COLLATERAL CIRCULATION AND THE CELIAC ARTERY WAS PERFUSING WITHOUT ISSUE. THE PATIENT WAS SENT TO RECOVERY. THE ANGIOGRAM PERFORMED ONE DAY POST IMPLANT SHOWED AN UNKNOWN FOCAL ENDOLEAK 15 MM PROXIMAL TO THE CELIAC ARTERY AND 30 MM PROXIMAL FROM THE DISTAL END OF THE STENT GRAFT, HOWEVER IT WAS THOUGHT TO BE A TYPE II ENDOLEAK AT THIS TIME. THE PHYSICIAN STATED THAT THERE WAS GOOD SEAL PROXIMALLY AND DISTALLY AND THE PATIENT WAS SENT HOME WITH NO INTERVENTION. THE PHYSICIAN HAD ANOTHER PHYSICIAN FROM ANOTHER HOSPITAL REVIEW THE FILMS. THE OTHER PHYSICIAN STATED IN THEIR OPINION THERE WAS EITHER A TYPE IB ENDOLEAK OR A TYPE IV ENDOLEAK (JETTING) AND THE PATIENT SHOULD HAVE AN INTERVENTION

  Patient problems: Injury

  MAUDE report 6146509 ↗