VALIANT® Captivia VAMF2626C100TURecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169347106), received between Feb 12, 2018 and Jul 8, 2025 — classified as 5 injuries, 2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2025Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFTS WAS IMPLANTED DURING THE TREATMENT OF A PENETRATING AORTIC ULCER (PAU) PROCEDURE. PER THE OPERATIVE NOTES, THE PATIENT WAS KNOWN TO HAVE A INFECTED AORTA AT THE TIME AND BEFORE IMPLANTING THE GRAFT, THE SURGEON SOAKED THE STENT GRAFT IN AN ANTIBIOTIC CALLED REVAMPIN. THE PATIENT WAS LOST TO FOLLOW AND WAS NOT TAKING ANTIBIOTICS TO GET RID OF THE INFECTION.  APPROXIMATELY 46 MONTHS POST INDEX PROCEDURE, A CT NOTED AN AORTO-EOSOPHAGEAL FISTULA (AEF) AND AN INTERCOSTAL TYPE II ENDOLEAK. RE -LINING WAS PERFORMED ON THE SAME DATE USING A NEW VALIANT CAPTIVIA DEVICE DUE TO THE NEED FOR AN EOSOPHAGECTOMY FOR THE AEF. PRIOR TO THE RE-LINING PROCEDURE, THE NEW GRAFT WAS SOAKED IN AN ANTIBIOTIC ALSO BEFORE IMPLANTING. PER THE PHYSICIAN THE SOURCE OR CAUSE OF THE INFECTION IS UNKNOWN. PER THE PHYSICIAN, THE AEF WAS ASSOCIATED WITH THE TEVAR PROCEDURE/DEVICE.

  Patient problems: Fistula

  MAUDE report 22435069 ↗
• MalfunctionMar 19, 2025Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE INVOLVING THE STENT GRAFT VAMF2626C100TU VALCAP FREFL, EXCESSIVE FORCE WAS NEEDED TO DEPLOY THE ENDOGRAFT AS PER THE PHYSICIAN. THE PATIENT WAS TREATED FOR BLUNT THORACIC AORTIC INJURY (BTAI). THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21642356 ↗
• InjuryMay 19, 2023Difficult to Remove; Device Damaged by Another Device; Positioning Problem; Difficult to Remove; Device Damaged by Another Device; Positioning Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A ULCER .  IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE VALIANT CAPTIVIA WAS INSERTED INTO THE PATIENT AND DEPLOYED, BUT THE DELIVERY SYSTEM WOULD NOT COME OUT AFTER THE DEPLOYMENT. THE PHYSICIAN PULLED AND WHEN THE DEVICE CAME OUT, IT WAS NOTICED THAT THE PATIENTS RIGHT ILIAC ARTERY HAD RUPTURED AND PART OF A NON MDT DEVICE WAS ON THE DELIVERY SYSTEM.  PER THE PHYSICIAN THE CAUSE OF THE REMOVAL DIFFICULTIES COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Perforation of Vessels

  MAUDE report 16960130 ↗
• InjuryJan 4, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN LENGTH DISSECTION.  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY TO ER. A CT PERFORMED SHOWED A RUPTURED THORACIC AORTA. THE PATIENT THEN UNDERWENT AN OPEN REPAIR AS TREATMENT.  PER THE PHYSICIAN THE CAUSE OF THE RUPTURE MAY HAVE BEEN ANATOMY AND QUESTIONED WHETHER THERE WAS ENOUGH NECK LENGTH TO BE TREATED DURING THE INDEX PROCEDURE AND WHETHER THE INDEX PROCEDURE WAS PERFORMED PER IFU.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 16093289 ↗
• InjuryApr 29, 2021Leak/Splash; Leak/Splash

  A VALIANT CAPTIVA STENT GRAFT (26-26-100) WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A PENETRATING ULCER OF THE MID ABDOMINAL AORTA AFTER THE PATIENT PRESENTED WITH ABDOMINAL PAIN. AT THE CONCLUSION OF THE PROCEDURE, IT APPEARED THAT THERE WAS SUCCESSFUL PROXIMAL AND DISTAL SEAL WITH WHAT APPEARED TO BE A TYPE IV ENDOLEAK. FOUR DAYS POST PROCEDURE, IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH SYMPTOMATIC ABDOMINAL PAIN AND A RUPTURED ANEURYSM. AN ENDURANT BIFURCATED SYSTEM WAS IMPLANTED AS TREATMENT, IT WAS REPORTED THE TREATMENT WAS SUCCESSFUL. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 11745251 ↗
• MalfunctionMar 29, 2019Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN EMERGENCY TRANSECTION. IT WAS REPORTED THAT ON CT ONE MONTH POST THE INDEX PROCEDURE A TYPE IA ENDOLEAK WAS OBSERVED AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS UNKNOWN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464647 ↗
• InjuryFeb 12, 2018Difficult To Position; Difficult To Position

  A VALIANT STENT GRAFT SYSTEM WAS ATTEMPTED TO BE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 46 MM THORACIC AORTIC ANEURYSM. THE DIAMETER OF THE LEFT ILIAC ARTERY WAS 6 MM AND 7 MM AT THE RIGHT ILIAC ARTERY. IT WAS REPORTED THAT THE PATIENT HAD SMALL ACCESS ANATOMY AND A NARROW CALCIFIED DISTAL AORTA. OTHER MANUFACTURER'S DILATORS, SHEATHS AND THE DOTTER TECHNIQUE WERE USED IN THE LEFT GROIN IN ORDER TO MAKE SPACE FOR THE DELIVERY SYSTEM. THE PHYSICIAN ADVANCED THE DEVICE HOWEVER THE DEVICE COULD NOT BE PASSED BEYOND THE AORTA ILIAC BIFURCATION. THE DEVICE WAS REMOVED AND THE PATIENT'S BLOOD PRESSURE DROPPED. RUPTURE HAD OCCURRED OF THE LEFT COMMON ILIAC ARTERY. A RELIANT BALLOON WAS PASSED THROUGH A SHEATH IN THE RIGHT GROIN TO THE ABDOMINAL AORTA AND THE BALLOON WAS INFLATE TO OCCLUDE AND TAMPONADE THE BLOOD LOSS. THE PROCEDURE WAS CONVERTED TO OPEN REPAIR AND THE RUPTURE WAS REPAIRED WITH AORTO BIFEMORAL BYPASS. THE TAA WAS NOT TREATED AT THIS TIME. THE VALIANT DEVICE WAS NOT IMPLANTED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY RELATED AND WAS DUE TO THE SMALL CALCIFIED DISTAL AORTA. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS ALIVE.

  Patient problems: Perforation of Vessels

  MAUDE report 7262962 ↗