VALIANT® Captivia VAMF3632C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169400153), received between Feb 9, 2017 and Sep 2, 2024 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Activation, Positioning or Separation Problem” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2024Difficult to Remove; Activation, Positioning or Separation Problem; Difficult to Remove; Activation, Positioning or Separation Problem

  A VALIANT CAPTIVIA WAS IMPLANTED FOR THE TREATMENT OF A 330MM AORTIC DISSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, AFTER SUCCESSFUL DEPLOYMENT OF THE STENT GRAFT, THE TRIGGER OF THE DELIVERY SYSTEM WOULD NOT ACTIVATE. AS A RESULT, THE TIP COULD NOT BE RETRACTED INTO THE GRAFT COVER AND THEREFORE, IT WAS REMOVED FROM THE PATIENT IN A OPENED POSITION. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO THE TRIGGER THAT WOULD NOT ACTIVATE PROPERLY. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20116702 ↗
• MalfunctionJul 24, 2024Material Deformation; Positioning Problem; Material Deformation; Positioning Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 70MM TAA. IT WAS NOTED THAT THE PATIENT HAD A PRIOR EVAR WITH NON MEDTRONIC STENT GRAFTS IN 2008 AND THE LIMBS OF THE EXISTING EVAR WERE BENT/KINKED AND DIFFICULT TO TRANSVERSE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE PHYSICIAN WAS ABLE TO PUSH THE DEVICE SLOWLY, DELIBERATELY AND INTERMITTENTLY TO A POINT, THEN IT WOULD NOT ADVANCE FURTHER. THE STENT GRAFT WAS 80MM SHORT OF THE TARGET WHICH WAS THE LSA. A DECISION WAS MADE TO REMOVE THE DEVICE, UPON WHICH IT WAS NOTICED THAT THE DISTAL PORTION OF THE DELIVERY SYSTEM HAD VISUAL AND TACTILE BENDS THROUGHOUT THE DELIVERY SHEATH WHICH HAD ENTERED THE PATIENT ANATOMY. A 24FR SHEATH WAS PLACED INTO THE ACCESS VESSEL AND ADVANCED BEYOND THE LOCATION OF THE LIMB BEND. THEN A DIFFERENT VAMF3632C150TU WAS SUCCESSFULLY DELIVERED TO THE TARGET SITE WITH WHAT THE PHYSICIAN DESCRIBED AS MINIMAL EFFORT. PER THE PHYSICIAN THE CAUSE OF THE BENDS TO THE DELIVERY SYSTEM WAS ANATOMY RELATED DUE TO THE BEND/KINK IN THE PREVIOUSLY IMPLANTED EVAR GRAFT. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19816306 ↗
• InjuryApr 3, 2023Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 80MM TAA.  IT WAS REPORTED THE PATIENT PRESENTED FOR FOLLOW-UP ON AN UNKNOWN DATE AND A TYPE IB ENDOLEAK WAS NOTED.  A NON MDT STENT GRAFT WAS IMPLANTED AS TREATMENT AND THE TYPE IB ENDOLEAK RESOLVED.  PER THE PHYSICIAN THE CAUSE OF THE IB ENDOLEAK WAS ANATOMY AND A SHORT DISTAL SEALING LENGTH.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 16661952 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 65MM THORACIC AORTIC ANEURYSM. THE PROCEDURE WHICH WAS CARRIED OUT PERCUTANEOUSLY AS PER PHYSICIANS CHOICE. IT WAS NOTED THIS PATIENT IS UNDERGOING A 2 STAGE PROCEDURE DUE TO THE COMPLEX ANATOMY AND WILL COME BACK FOR A PLANNED SECOND STAGE OF HER REPAIR. IT WAS REPORTED DURING THE INDEX, THE PHYSICIAN STARTED OFF WITH RUNNING THE 20 FRENCH DILATOR UP THE ILIAC WHICH IT PASSED WITH NO ISSUES. THE 3 VALIANT CAPTIVIA DEVICES WENT UP AND DEPLOYED WITH NO ISSUES. UPON COMPLETION A RETROGRADE ANGIOGRAPHY OF THE LEFT ILIAC SYSTEM WAS TAKEN AND IT WAS FOUND THAT THE DISTAL COMMON ILIAC HAD A SMALL DISSECTION. THE PHYSICIAN FINISHED THE TAA PORTION OF THE PROCEDURE BY WORKING ON THE LEFT SUBCLAVIAN . AFTER THE LEFT SUBCLAVIAN WAS FINISHED, THE PHYSICIAN WENT BACK TO ADDRESS THE LEFT COMMON ILIAC. WHEN PULLING THE 20 FRENCH SHEATH BACK, THE PHYSICIAN FELT SOMETHING GIVE. A RETROGRADE ANGIOGRAPH WAS PERFORMED SHOWING THE EXTERNAL ILIAC WAS TRANSECTED 4 NON-MDT STENTS WERE IMPLANTED TO CONTROL THE BLEEDING. THE PATIENT REMAINED STABLE THE ENTIRE PROCEDURE AND BLOOD PRESSURE DID NOT DROP. THE LEFT INTERNAL WAS COV

  Patient problems: Rupture; Vascular Dissection

  MAUDE report 14562259 ↗
• MalfunctionSep 6, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 65MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN MODIFIED THE VALIANT STENT GRAFT SYSTEM AND PLACED IT IN THE ABDOMINAL AORTA WITH FENESTRATIONS. IT WAS REPORTED THAT THE MODIFIED GRAFT COULD NOT ROTATE DUE TO THE PATIENT ANATOMY AND WAS PARTIALLY DEPLOYED IN THE ABDOMINAL AORTA UNDER EXTREME TORQUE. UPON DELIVERY OF THE STENT GRAFT, THE TOP CAP RELEASED DUE TO TORQUE. THE RIGHT RENAL FENESTRATION COULD NOT BE CANNULATED. THE LEFT RENAL WAS CANNULATED AND AN ATRIUM STENT GRAFT WAS INSERTED. THE PHYSICIAN PLACED ANOTHER MANUFACTURERS 35MM STENT GRAFT TO COMPLETE THE ABDOMINAL PORTION OF THE STENT GRAFT. THE RIGHT RENAL COULD NOT CANNULATE AND THE FENESTRATION REMAINED OPEN. IT WAS REPORTED THAT THE FOLLOWING DAY, RE-INTERVENTION WAS PERFORMED TO CANNULATE THE RENAL. THIS WAS UNSUCCESSFUL AND SO ANOTHER ATTEMPT WAS MADE 3 DAYS LATER AGAIN. THE PHYSICIAN DID AN APPROACH VIA THE ARM AND GROIN AND EVENTUALLY PLACED AN ATRIUM COVERED STENT AS A SNORKEL INTO THE RIGHT RENAL FROM ABOVE BEHIND THE STENT GRAFT. AN ATRIAL SEPTAL PLUG WAS PLACED IN T

  Patient problems: Injury

  MAUDE report 7850304 ↗
• InjuryMar 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. THE AORTA NEAR THE BRACHIOCEPHALIC TRUNK MEASURED APPROXIMATELY 38 MM IN DIAMETER. THE AORTA NEAR THE LEFT SUBCLAVIAN ARTERY MEASURED APPROXIMATELY 36 MM IN DIAMETER. THE PATIENT HAD AN ENLARGED, GREATER THAN 4 CM, ASCENDING AORTA AND IT WAS NOTED THAT THIS WAS A RISK FACTOR FOR RETROGRADE TYPE A AORTIC DISSECTIONS. IN THE MORNING, TWO DAYS POST INDEX PROCEDURE, THE PATIENT CODED AND REQUIRED CPR. BEDSIDE TTE SHOWED A LARGE PERICARDIAL EFFUSION. DUE TO SUSPECTED ACUTE TYPE A AORTIC DISSECTION, THE PATIENT WAS TAKEN EMERGENTLY TO THE OPERATING ROOM FOR CONFIRMATION OF THE DIAGNOSIS BY TEE AND SURGICAL INTERVENTION. ON ARRIVAL TO THE OPERATING ROOM (OR), THE PATIENT WAS SEVERELY HYPOTENSIVE (SBP~30/). TEE CONFIRMED THE PRESENCE OF A LARGE PERICARDIAL EFFUSION WITH A TYPE A AORTIC DISSECTION. A DECISION WAS MADE TO RELIEF THE CARDIAC TAMPONADE. DURING THE OPEN CHEST PROCEDURE, THERE WAS EVIDENCE OF CONTINUED MASSIVE BLEEDING THROUGH THE OPENING IN THE PERICARDIAL SAC. A DECISION WAS MADE TO ESTABLISH CARDIOPULMONARY BYPASS THROUGH THE FEMORAL VESSELS. THE PERICARDIUM WAS OPENED LONGITUDINALLY WITH EVIDENCE OF FREE RUPTURE OF THE ASCENDING AORTA. A CARD

  Patient problems: Blood Loss; Low Blood Pressure/ Hypotension; Pericardial Effusion; Vascular Dissection

  MAUDE report 6421243 ↗
• InjuryFeb 9, 2017Occlusion Within Device; Occlusion Within Device

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM IN DIAMETER ULCER IN THE DESCENDING THORACIC AORTA. THE THORACIC AORTA WAS NON-TORTUOUS. TWO VALIANT STENT GRAFTS WERE DEPLOYED WITHOUT ISSUE. PRIOR TO THE DELIVERY OF THE THIRD VALIANT STENT GRAFT, THE GUIDEWIRE POSITIONING WAS LOST AND THEN REPOSITIONED. IT WAS REPORTED THAT AFTER THE THIRD DISTAL VALIANT STENT GRAFT WAS DEPLOYED THE TOP 1/3RD PORTION ON ONE SIDE OF THE STENT GRAFT APPEARED TO BE MAL-DEFORMED/INFOLDED/CRUSHED AND NOT FULLY OPPOSED AGAINST THE OTHER STENT GRAFT OR VESSEL WALL. AFTER STENT GRAFT DEPLOYMENT, THERE WAS A PRESSURE GRADIENT BETWEEN THE THORACIC AREA AND THE FEMORAL ARTERY AREA WAS MORE THAN 100 MM OF MERCURY DUE TO STENOSIS/THROMBOSIS FORMATION. THE PHYSICIAN ELECTED TO PERFORM AN AXILLO-BI-FEMORAL BYPASS. THE BLOOD FLOW WAS RESTORED. THE PHYSICIAN STATED THE CAUSE OF THE EVENT IS RELATED TO THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Occlusion

  MAUDE report 6317800 ↗