VALIANT® Captivia VAMF3030C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169347083), received between Jan 20, 2017 and Mar 20, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 16, 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.

• MalfunctionMar 20, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING THE REMOVAL OF THE STENT GRAFT VAMF3030C100TU VALCAP FREFL DELIVERY SYSTEM USED IN THE TREATMENT OF AN AORTIC ULCER, THE TAPER TIP AND WIRE LUMEN ATTACHED TO THE TAPER TIP DISCONNECTED FROM THE DELIVERY SYSTEM AND REMAINED IN THE PATIENT. THE PHYSICIAN WAS ABLE TO RETRIEVE THE WIRE LUMEN AND NOSE CONE FROM THE PATIENT OVER THE DELIVERY WIRE. SIZING WORKSHEET AND 3D RECONSTRUCTION DATA INDICATED A PROXIMAL THORACIC AORTA DIAMETER OF 26MM AT IMPLANT, WITH MILD ANGULATION, TORTUOSITY, AND MODERATECALCIFICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. PER THE PHYSICIAN NO EXCESSIVE FORCE WAS NEEDED TO REMOVE THE DELIVERY SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646887 ↗
• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS SUCCESSFULLY IMPLANTED DURING ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. DURING THE PROCEDURE, A RELIANT STENT GRAFT BALLOON (REL46) WAS UTILIZED TO ENHANCE CONTACT BETWEEN THE STENT GRAFT AND THE VESSEL WALL. THE PATIENT WAS DISCHARGED ON THE DAY OF THE PROCEDURE. IT WAS REPORTED ON THE SAME DATE, THE PATIENT RETURNED TO THE EMERGENCY DEPARTMENT LATER IN THE EVENING, REPORTING FEELING VERY WARM WITH A TEMPERATURE OF 102 °F . ADDITIONALLY, THE PATIENT EXPERIENCED ONGOING BACK PAIN, WHICH THE PATIENT THOUGHT TO BE ATTRIBUTED TO THE HOSPITAL BEDS. THE PATIENTS WHITE BLOOD CELL COUNT WAS 15.3, WHICH HAD BEEN FLUCTUATING . BLOOD CULTURES PENDING. THE PATIENT WAS COMMENCED ON AN ANTIBIOTIC TREATMENT (VANCOMYCIN) THE FOLLOWING DAY. INFECTION WORK UP WAS NEGATIVE. THE PATIENT WAS DIAGNOSED WITH POST IMPLANTATION SYNDROME, RELATED TO THE STENT GRAFT PLACEMENT. THE PATIENTS CONDITION RESOLVED 3 DAYS LATER AND THE PATIENT WAS THEN DISCHARGED FROM HOSPITAL. ADDITIONALLY WHEN THE PATIENT PRESENTED ON THE SAME DAY AS THE PROCEDURE, AN INCIDENTAL FINDING OF A RIGHT GROIN RETROPERITONEAL HE MALTOMA ASSOCIATED WITH ANEMIA WAS NOTED. NO ACTION WAS REQUI

  Patient problems: Anemia; Fever; Hematoma; Pain

  MAUDE report 19318367 ↗
• MalfunctionNov 14, 2023Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS INTENDED TO BE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A BTAI. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE THE SIDE FLUSH PORT OF THE VALIANT CAPTIVIA WOULD NOT FLUSH. ANOTHER VALIANT CAPTIVIA STENT GRAFT WAS USED TO COMPLETE THE PROCEDURE. NO CAUSE WAS PROVIDED. NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENTS IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18128983 ↗
• InjuryOct 2, 2023Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT (VAMF3030C100TU) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED DURING A FOLLOW UP CT 5 DAYS LATER , THE PHYSICIAN IDENTIFIED AN ENDOLEAK. THE CT WAS REVIEWED AND IT WAS DETERMINED THAT THE OBSERVED ENDOLEAK APPEARED TO BE A TYPE IIIB. THE FOLLOWING DAY, THE STENT GRAFT WAS RELINED WITH A COMPETITOR STENT GRAFT. IT WAS CONFIRMED DURING THE INDEX PROCEDURE, THE VALIANT CAPTIVIA STENT GRAFT WAS DEPLOYED IN THE NORMAL FASHION WITHOUT ANY ISSUE THAT COULD INDICATE A CAUSE FOR THE TYPE III ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE TYPE III ENDOLEAK WAS DUE TO STENT GRAFT DEFECT. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED, AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17850159 ↗
• InjuryJun 4, 2019Difficult to Insert; Difficult to Insert

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS INTENDED FOR IMPLANT IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 14 MM THORACIC AORTIC PAU. THE DIAMETER OF THE AORTA AT THE PAU WAS 42 MM. THE PATIENT HAD A PREVIOUS EVAR WITH AN ENDURANT DEVICE ON AN UNKNOWN DATE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN FIRST TRIED TO GAIN ACCESS VIA THE RIGHT SIDE, BUT IT WAS OCCLUDED. THEY THEN ACCESSED THE LEFT COMMON FEMORAL, WHICH WAS NARROW. THE PHYSICIAN USED A NON-MEDTRONIC PTA 7 X 60 MM NON-COMPLIANT BALLOON. THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE VALIANT CAPTIVIA PERCUTANEOUSLY VIA THE ACCESS VESSEL, BUT IT DID NOT ADVANCE. THE PHYSICIAN THEN IMPLANTED TWO 8 X 59 MM NON-MEDTRONIC AND ONE 8 X 39 MM, AND ADVANCED AN 18 FR NON-MEDTRONIC DILATOR THROUGH THE STENTS. AN ATTEMPT WAS THEN MADE TO ADVANCE A 20 FR SENTRANT DILATOR THROUGH THE DISTAL NON-MEDTRONIC STENT, BUT IT DID NOT ADVANCE. THE PHYSICIAN THEN INFLATED A 9 MM NON-MEDTRONIC BALLOON IN THE 3 STENTS. THEY THEN ATTEMPTED TO ADVANCE THE 18 FR NON-MEDTRONIC SHEATH, BUT IT DID NOT ADVANCE. AN ANGIOGRAM WAS THEN PERFORMED, AND IT WAS OBSERVED THAT THE DISTAL LEIA WAS RUPTURED AND THERE WAS EXTRAVASATION OUTSIDE

  Patient problems: Paralysis; Perforation of Vessels; Stroke/CVA

  MAUDE report 8666571 ↗
• InjuryMar 6, 2019Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A BLUNT THORACIC AORTIC INJURY.   IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE DEVICE WAS DEPLOYED SUCCESSFULLY AND THE DELIVERY SYSTEM WAS PREPARED FOR REMOVAL, WITH THE NOSE CONE RE-MARRIED TO THE GRAFT COVER. WHEN REMOVING THE DELIVERY SYSTEM THE NOSE CONE BECAME STUCK AND SEPARATED FROM GRAFT COVER. THE INNER TUBE SEEMED TO STRETCH WHEN THE PHYSICIAN PULLED HARDER TO REMOVE THE DELIVERY SYSTEM. THE PHYSICIAN THEN STOPPED AND USED THE C-ARM TO DETERMINE WHERE THE NOSE CONE WAS LOCATED. IT APPEARED TO BE STUCK AT SUBCUTANEOUS TISSUE OR SKIN LEVEL AND NO LONGER IN THE ARTERY. WHILE THE ASSISTANT HELD PRESSURE THE PHYSICIAN SPREAD THE TISSUE WITH A HEMOSTAT AND RAISED THE ANGLE OF REMOVAL OF THE NOSE CONE. THIS ALLOWED IT TO BE REMOVED. A PERCLOSE DEVICE WAS THEN USED SUCCESSFULLY TO CLOSE THE ARTERIOTOMY. NO ISSUES WITH PATIENT WERE REPORTED. THE REMOVAL PROCESS MAY HAVE EXTENDED THE PROCEDURE BY 3-5 MIN. THE DEVICE WAS EXAMINED AFTER THE PROCEDURE AND THE NOSE CONE WOULD NOT RE-SEAT IN THE GRAFT COVER. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO THE NOSE CONE GE

  Patient problems: Injury

  MAUDE report 8393845 ↗
• MalfunctionJan 20, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PENETRATING ATHEROSCLEROTIC ULCER. IT WAS REPORTED THAT, DURING THE INDEX PROCEDURE, SOME OF THE PROXIMAL SPRINGS TOOK A FEW SECONDS TO RELEASE FROM THE TIP CAPTURE MECHANISM OF THE DELIVERY SYSTEM WHEN THE VALIANT STENT GRAFT WAS BEING DEPLOYED. THE BARE SPRING STENT WAS NOT RELEASED IN A UNIFORM MANNER. THE DEVICE WAS SUCCESSFULLY DEPLOYED AND THERE WAS NO CONSEQUENCE TO THE PATIENT. THE CAUSE OF THE EVENT WAS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6267842 ↗