VALIANT® Captivia VAMF3030C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00643169346994), received between Jan 26, 2017 and Dec 2, 2025 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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.

• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THREE VALIANT CAPTIVIA STENT GRAFTS (VAMF3030C150TU, VAMC2824C150TU AND VAMC3026C150TU) WERE IMPLANTED DURING DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT TWO WEEKS LATER, THE PATIENT PRESENTED WITH CHEST PAIN AND WAS FOUND TO HAVE A TYPE A DISSECTION AND INTRAMURAL HEMATOMA (IMH) FOLLOWING A CT SCAN. IT WAS NOTED THAT DUE TO THE PATIENT'S PAIN, SURGICAL INTERVENTION WAS PERFORMED TWO DAYS LATER. DURING THE PROCEDURE, THE ASCENDING AORTA WAS REPAIRED WITH A VALIANT CAPTIVIA (VAMC3232C100TU) AND A SURGICAL GRAFT WAS SEWN TO THIS STENT GRAFT. THE BRACHIOCEPHALIC AND LEFT CAROTID ARTERIES WERE BYPASSED. THE LEFT SUBCLAVIAN ARTERY WAS NOTED TO BE FRIABLE AND REQUIRED LIGATION. THE PATIENT WAS TREATED FOR IMH AND TYPE A DISSECTION. AFTER THE PROCEDURE, THE PATIENT WAS EXTUBATED , AWAKE, ALERT AND FOLLOWING COMMANDS. THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Pain; Vascular Dissection

  MAUDE report 23690850 ↗
• InjuryJan 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA. A SENTRANT SHEATH WAS USED AS AN ACCESSORY DEVICE DURING THE PROCEDURE.  IT WAS REPORTED THE PATIENT HAD A VISIT WITH THEIR PRIMARY CARE PROVIDER . THE PATIENT COMPLAINED OF RIGHT WRIST PAIN. REDNESS WAS NOTED AT THE SITE OF THE PREVIOUS ARTERIAL LINE INFILTRATION. THE PATIENT WAS DIAGNOSED WITH CELLULITIS. THE PATIENT WAS COMMENCED ON PO ANTIBIOTICS AS TREATMENT.  THE SITE ASSESSED THIS EVENT AS NOT RELATED TO AN UNDERLYING CONDITION OR DISEASE AND HAVING A PROBABLY RELATIONSHIP TO THE STUDY PROCEDURE.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Cellulitis

  MAUDE report 16263123 ↗
• InjuryMay 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF MULTIPLE PAUS. IT WAS REPORTED ON FOLLOW UP CTS THAT THERE HAS BEEN PERSISTENT SOFT TISSUE THICKENING, GAS AND FLUID ABOUT THE ENDOGRAFT MEASURING UP TO 1.2 CM IN THICKNESS, WITH A SLIGHT INCREASE ON THE MOST RECENT CT. CHRONIC INFECTION WAS CONSIDERED. ON (B)(6) 2022 THE PATIENT UNDERWENT AN ESOPHAGOGASTRODUODENOSCOPY WITH BIOPSY AND A COLONOSCOPY. AN ESOPHAGEAL FISTULA WHICH WAS OBSERVED TO BE OOZING AND CONTAINED A CLOT WAS OBSERVED. THE CLOT WAS REMOVED BY SUCTIONING. AFTER THE CLOT WAS REMOVED A WIRE(MESH PATTERN) AT THE BASE OF THE FISTULA WAS OBSERVED. NO BLEEDING FROM THE AREA WAS SEEN. PER THE PHYSICIAN THE CAUSE OF THE INFECTION AND FISTULA IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Fistula; Thrombosis/Thrombus; Unspecified Infection

  MAUDE report 14461082 ↗
• InjuryJun 26, 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 70 MM THORACOABDOMINAL ANEURYSM. CALCIFICATION WAS NOTED IN THE EXTERNAL ILIACS. IT WAS REPORTED DURING THE INDEX PROCEDURE THE FIRST DEVICE 30X30X150 VALCAP WAS ADVANCED THROUGH THE ILIACS WITHOUT TROUBLE AND PLACED IN THE CORRECT POSITION. HOWEVER, THE SECOND DEVICE, 34X34X150 VALCAP WOULD NOT ADVANCE THROUGH THE ILIAC SO IT WAS REMOVED FOLLOWED BY ANGIOPLASTY OF THE ILIACS. A RE-ATTEMPT TO PLACE THE DEVICE WAS MADE; HOWEVER UNSUCCESSFULLY. THE DEVICE WAS REMOVED FROM THE RIGHT FEMORAL AND AN 18FR SHEATH WAS PLACED TO PLUG THE HOLE. THE DEVICE WAS ADVANCED INTO THE LEFT ILIAC WITHOUT ISSUE AND DEPLOYED. WHEN THE DEVICE WAS REMOVED FROM THE LEFT ILIAC THE PATIENT¿ BLOOD PRESSURE DROPPED. AN ANGIOGRAM SHOWED AN EXTERNAL ILIAC RUPTURE ON THE LEFT SIDE. THE RUPTURE WAS REPAIRED. ONCE THE LEFT SIDE WAS REPAIRED THE SHEATH IN THE RIGHT SIDE WAS REMOVED HOWEVER THE PATIENTS PRESSURE DROPPED AGAIN. ANOTHER ANGIOGRAM REVEALED THE RIGHT EXTERNAL ILIAC HAD ALSO RUPTURED. TWO ENDURANT LIMBS (10X10X82 AND 13X13X 82) WERE PLACED IN THE RIGHT EXTERNAL ILIAC. THE ILIAC WAS STILL LEAKING FOLLOWING THE PLAC

  Patient problems: Rupture

  MAUDE report 7637018 ↗
• MalfunctionJan 18, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC TRANSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN FELT THAT THE PROXIMAL END OF THE GRAFT ON THE INFERIOR CURVE WAS BIRD-BEAKING. THE PHYSICIAN EXPRESSED CONCERN ABOUT HOW THE STENT GRAFT WAS TAKING THE GOTHIC AORTIC ARCH. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO THE CONFORMABILITY OF THE GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPOR TED, AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7203375 ↗
• InjuryApr 12, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS SELECTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC ULCER. IT WAS REPORTED THAT THE PATIENT RETURNED FOR A ROUTINE FOLLOW UP. A CT REVEALED A SMALL PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO MODEL THE VALIANT STENT GRAFT WITH A BALLOON AND THE PROXIMAL TYPE I ENDOLEAK WAS RESOLVED. PER THE PHYSICIAN, THE EXACT CAUSE OF THE PROXIMAL TYPE I ENDOLEAK IS CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 6488094 ↗
• MalfunctionJan 26, 2017Break; Break

  A VALIANT STENT GRAFT SYSTEM WAS SELECTED FOR USE, BUT NOT INSERTED IN THE PATIENT, FOR THE SECOND PART OF A SCHEDULED STAGED ENDOVASCULAR TREATMENT OF THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT THE SIDE ARM FLUSH PORT DETACHED FROM THE DELIVERY SYSTEM DURING PREPPING OF THE DEVICE. WHEN THE TECHNICIAN ATTEMPTED TO ATTACH THE SYRINGE TO THE SIDE ARM FLUSH PORT THE SIDE ARM FLUSH PORT DETACHED. UPON REMOVAL OF THE DEVICE FROM THE PACKAGING THERE WAS NO OBVIOUS DELIVERY SYSTEM ISSUES NOTED. THE OUTER BOX PACKAGING AND THE INNER PACKAGING DID NOT HAVE ANY DAMAGE. THE PHYSICIAN USED ANOTHER DEVICE AND THE CASE WAS SUCCESSFULLY COMPLETED. THE PHYSICIAN DOES NOT KNOW THE CAUSE OF THE EVENT, MAYBE RELATED DEVICE ISSUE OR POSSIBLE DAMAGE DURING SHIPPING. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Patient Involvement

  MAUDE report 6280189 ↗