VALIANT® Captivia VAMF3838C150TU (UDI 00643169346956)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00643169346956), received between Feb 21, 2017 and Jul 30, 2026 — classified as 4 deaths, 9 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (8 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJul 30, 2026Leak/Splash; Device Damaged by Another Device

  A modified Valiant Captivia stent graft VAMF3838C150TU was implanted during the endovascular treatment of 69mm ascending thoracic aortic aneurysm in the ascending Aorta. Pt disease was a focal PAU starting in the distal aspect of Zone 2. The Physician unsheathed the VAMF3838C150TU on the back table and modified the graft according to the "Double Fenestrated Valiant Captivia" published literature creating a large fenestration "window", 25mm distal to the graft edge and then creating an 8mm wire tipped reinforced fenestration 5mm distal to the large proximal fenestration. A 260cm Glide wire was used after an 18gauage angiocath puncture of the delivery sheath to provide a "pre-cannulated wire for the LSA. The graft stent struts were systematically reconstrained with silk ties and the graft was resheathed, releasing silk ties appropriately. As planned- the pre-cannulated wire exited the tip of the device, above the graft from the LSA to edge, but "within" the graft delivery sheath. Moderate calcification of the aortic bifurcation as well as the bilateral CIA in the proximal 20mm, mild/moderate tortuosity of the CIA from the mid-proximal segment. It was reported during the index procedu

  Patient problems: Paresis; Stroke/CVA

  MAUDE report 50083887 ↗
• MalfunctionMay 27, 2026Activation, Positioning or Separation Problem; Material Deformation

  IT WAS REPORTED THAT DURING AN INDEX THORACIC ENDOVASCULAR AORTIC PROCEDURE USING A VALIANT CAPTIVIA STENT GRAFT FOR TREATMENT OF AN ULCER, THE STENT GRAFT APPEARED TO JAM AFTER APPROXIMATELY 1CM OF DEPLOYMENT. AT THAT POINT, THE GRAFT MATERIAL HAD NOT YET BEEN EXPOSED, AND THE GRAFT COVER COULD NOT BE RETRACTED ANY FURTHER. THE PHYSICIAN ADJUSTED AND ATTEMPTED DEPLOYMENT AGAIN, BUT REMOVED THE DEVICE BEFORE FURTHER GRAFT MATERIAL WAS EXPOSED WITHOUT CAUSING DAMAGE TO THE PATIENT OR DISRUPTING THE PREVIOUS EVAR IMPLANT. A BACKUP 38 × 38 × 167 MM VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED WITH A SUCCESSFUL RESULT. POST-CASE EXAMINATION FOUND THE STENT GRAFT COVER COULD NOT BE RETRACTED BEYOND APPROXIMATELY 2 CM, AND SCREW THREADS BEGAN TO SHEAR, PRODUCING PLASTIC SHAVINGS WITHIN THE DEPLOYMENT HANDLE. THE PHYSICIAN ALLEGED A MANUFACTURING ISSUE INVOLVING THE SCREW THREADS. NO APPARENT DAMAGE TO THE OUTER BOX OR INNER PACKAGING WAS IDENTIFIED. THE PATIENT WAS REPORTED ALIVE WITH NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25296589 ↗
• DeathApr 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED TO TREAT A DISSECTION DURING A TAVI PROCEDURE ON (B)(6) 2023. THE PROCEDURE WAS COMPLETED AS THE PATIENT HAD A FAILED HEART VALVE. IT WAS REPORTED PRIOR TO THE IMPLANT OF THE VALIANT STENT GRAFT, NO PRE/POST DILATION WAS PERFORMED. A NON MDT WIRE AND EVOLUT 29 DEVICE WERE USED. 2 OR 3 READVANCES OVER THE ARCH WAS PERFORMED DUE TO COMMISSURAL MISALIGNMENT WITH 1 RECAPTURE. FINAL GRADIENT OF 7 MMHG, NO PVL/ AI. AN AORTIC ARCH DISSECTION OCCURRED. A VALIANT CAPTIVA GRAFT WAS DEPLOYED IN AN EFFORT OF SLOWING THE BLEED. THE DISSECTION CAUSED A DECOMPENSATION OF THE PATIENT THAT COULD NOT BE REVERSED IN A TIMELY MANNER AND THE PATIENT EXPIRED. IT WAS REPORTED THE AORTIC ARCH DISSECTION WAS MOST LIKELY CAUSED BY THE PASSING OF THE EVOLUT FX DELIVERY SYSTEM THROUGH THE ANATOMY. THE CONCLUSION BY THE IMPLANTING TEAM IS THAT THE MAIN INJURY OCCURRED BEFORE THE VALIANT GRAFT WAS IMPLANTED AND THE PATIENT WAS NOT ABLE TO RECOVER BY THE TIME THIS STEP WAS TAKEN.

  Patient problems: Insufficient Information

  MAUDE report 19105331 ↗
• DeathMay 5, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 68MM THORACIC AORTIC ANEURYSM. THE PHYSICIAN IMPLANTED A VAMF3838C150TU FOLLOWED BY VAMC4238C150TU PROXIMAL TO CELIAC. IT WAS REPORTED DURING THE INDEX PROCEDURE FOLLOWING THE IMPLANT OF THE TWO VALIANT CAPTIVIA STENT GRAFTS, BALLOONING WAS COMPLETED WITH RELIANT BALLOON AT THE OVERLAP SECTION AND DISTAL GRAFT SEAL ZONE. ON THE FINAL ANGIOGRAM A TYPE IA ENDOLEAK WAS OBSERVED. THE PHYSICIAN AT FIRST THOUGHT IT WAS AS A RESULT OF THE PATIENT ANATOMY MEASURING 33-35MM. THE PHYSICIAN BALLOONED THE TOP OF THE GRAFT WHICH IMPROVED THE ENDOLEAK. ANOTHER ANGIOGRAM WAS PERFORMED AND THE GRAFT WAS THEN EXTENDED PROXIMALLY WITH A VAMF3838C100TU. BALLOONING OF THE OVERLAP OF GRAFT WAS PERFORMED WITH RELIANT BALLOON. FINAL ANGIOGRAM SHOWED NO ENDOLEAK AND CASE WAS A TECHNICAL SUCCESS. POSTPROCEDURE, A FEW HOURS LATER, THE PHYSICIAN NOTED THE PATIENT HAD WOKEN UP AND WAS MOVING ALL EXTREMITIES, BUT THEN THE PATIENT CODED AND CPR WAS COMMENCED BUT THE PATIENT EXPIRED. AS PER THE PHYSICIAN THE CAUSE OF DEATH COULD HAVE BEEN DUE TO A TYPE A DISSECTION, BUT WITHOUT IMAGING THE PHYSICIAN WAS NOT CERTA

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 14285392 ↗
• InjuryApr 20, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 72MM THORACIC DISSECTION. 24 HOURS POST PROCEDURE THE PATIENT COMPLAINED OF CHEST PAIN AND LOST MOTOR FUNCTION OF BOTH LEGS. CT REVEALED PARTIAL OCCLUDED BRACHIAL ARTERY WITH APPROX. 90% COVERAGE OF THE LSA OSTIA. IT WAS DETERMINED THAT THE LSA COVERAGE MAY BE A CONTRIBUTING FACTOR TO THE ACUTE SPINAL CORD INJURY. A SPINAL DRAIN WAS PLACED INTO THE PATIENT AND THE MAIN ARTERIAL PRESSURE WAS DRIVEN UP INTO THE 90S. AN ADDITIONAL STENT WAS ALSO PLACED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS USER ERROR. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion; Pain; Paralysis; Spinal Cord Injury

  MAUDE report 11693122 ↗
• InjuryApr 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 55 MM THORACIC ABDOMINAL ANEURYSM. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR FOLLOW UP APPROXIMATELY 2 YEARS 2 MONTHS LATER, DISTAL EXPANSION OF THE ANEURYSM WAS REPORTED. INTERVENTION WAS CARRIED OUT TWO DAYS LATER, WITH AN EXTENSION IMPLANTED DISTALLY TO SEAL THE ANEURYSM. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS NOT DEVICE RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8496417 ↗
• DeathFeb 5, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM WERE IMPLANTED IN A PATIENT FOR THE EMERGENCY ENDOVASCULAR TREATMENT OF A RUPTURED PROXIMAL DESCENDING THORACIC AORTIC ANEURYSM. IT WAS NOTED THE PATIENT HAD A NON-MDT DEVICE IMPLANTED APPROXIMATELY TWO WEEKS PRIOR TO THIS EVENT FOR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH BLOOD IN THE CHEST CAVITY DUE TO THE RUPTURE. TWO VALIANT STENT GRAFTS WERE PLACED DURING THE INDEX PROCEDURE WITHOUT ANY COMPLICATIONS VIA THE LEFT GROIN. IT WAS REPORTED THAT FINAL IMAGING SHOWED SUCCESSFUL GRAFT PLACEMENT HOWEVER THE PATIENT'S BLOOD PRESSURE DROPPED CONSIDERABLY. MEDICATION WAS ADMINISTERED AND CPR COMMENCED. FURTHER IMAGING OBTAINED REVEALED NO ABNORMALITIES EXCEPT FOR SLOW FLOW VIA THE DISTAL STENT GRAFT DUE TO LOW BLOOD PRESSURE. THE PHYSICIAN PLACED A CHEST TUBE AND LARGE AMOUNT OF BLOOD WAS EVACUATED BUT DESPITE THIS THE PATIENT'S BLOOD PRESSURE CONTINUED TO DROP AND THE PATIENT EXPIRED. PER THE PHYSICIAN THE CAUSE OF DEATH WAS NOT RELATED TO THE VALIANT DEVICE AND COMMENTED THAT A DROP IN BLOOD PRESSURE OCCURRED DURING REMOVAL OF THE LARGE 18F NON-MDT SHEATH FROM THE LEFT GROIN LEADING TO A CARDIAC EVENT AND A

  Patient problems: Death

  MAUDE report 8304073 ↗
• MalfunctionDec 18, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE FINAL ANGIOGRAM SHOWED A SMALL TYPE IA ENDOLEAK. THE PROXIMAL END OF THE GRAFT WAS BALLOONED WITH A RELIANT HOWEVER IT IS UNKNOWN IT THE ENDOLEAK RESOLVED AS A FURTHER ANGIOGRAM WAS NOT CARRIED OUT DUE TO RENAL ISSUES WITH THE PATIENT. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS PATIENT'S DISEASED AORTA. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8173691 ↗
• InjuryDec 18, 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 THORACIC AORTIC ULCER. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY TWO MONTHS LATER WITH BACK PAIN. A CT CONFIRMED A TYPE A RETROGRADE DISSECTION. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT WAS DEVICE RELATED. THE PATIENT HAS NOT RECEIVED TREATMENT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Intimal Dissection; Pain

  MAUDE report 8172969 ↗
• DeathJun 27, 2018Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM WAS PLANNED FOR USE IN A PATIENT FOR AN AORTIC TEAR. IT WAS REPORTED THAT THE PATIENTS WIFE CALLED TECHNICAL SERVICES ASKING WHY AN ID CARD WAS SENT TO HER ADDRESS FOR HER HUSBANDS DEVICE AS HE HAD EXPIRED 2 WEEKS PREVIOUSLY. IT WAS REPORTED THAT THE PATIENT HAD SURGERY FOR A TEAR IN THE AORTA BUT NEVER RECOVERED FROM SURGERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Blood Loss; Death

  MAUDE report 7640826 ↗
• InjuryMay 4, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT ON CT APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE A TYPE IB ENDOLEAK WAS OBSERVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO AORTIC REMODELLING AND TORTUOSITY OF THE DISEASED DESCENDING THORACIC AORTA WHICH CAUSED LOSS OF STENT GRAFT APPOSITION. THE PATIENT RECEIVED INTERVENTIONAL TREATMENT TO RELINE THE STENT GRAFT WITH A LONGER VALIANT STENT GRAFT. THIS PROVIDED EXTENSION PROXIMALLY TO THE CELIAC ARTERY TO OBTAIN SEAL AND DISTALLY TO RESOLVE THE TYPE IB ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 7487535 ↗
• MalfunctionMay 1, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 70MM THORACIC AORTIC ANEURYSM. IT WAS RE PORTED THAT A TYPE IA ENDOLEAK WAS OBSERVED FOLLOWING A CT SCAN CARRIED OUT 5 MONTHS LATER. THE PHYSICIAN HAS REPORTED THAT THAT CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS BEING MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7474967 ↗
• MalfunctionJan 16, 2018Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 52MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE ER AFTER SUSTAINING A FALL APPROXIMATELY 1 MONTH POST THE INDEX PROCEDURE. IT WAS NOTED ON CT EXAM THAT A TYPE I LEAK WAS PRESENT. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7192816 ↗
• InjuryNov 3, 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 AN ULCER. HOWEVER, IT WAS REPORTED THAT APPROXIMATELY 3 MONTHS POST IMPLANT, A CT REVEALED PROXIMAL REMODELING WITH A SMALL TEAR/DISSECTION APPROXIMATELY 2 CM IN LENGTH WITH COMMUNICATION TO THE PROXIMAL BARE SPRING, STARTING 4 CM DISTAL TO THE LEFT SUBCLAVIAN ARTERY EXTENDING TO THE TOP OF THE STENT GRAFT MATERIAL. THE PHYSICIAN DOES NOT CONSIDER THE EVENT TO BE SYMPTOMATIC AT THIS TIME; THEREFORE, NO INTERVENTION WAS PERFUMED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO THE PATIENT¿S ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL CONTINUE TO BE MONITORED BY THE PHYSICIAN.

  Patient problems: Vascular Dissection

  MAUDE report 6998642 ↗
• InjuryNov 1, 2017Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ASYMPTOMATIC THORACIC AORTIC ANEURYSM. THE PHYSICIAN ELECTED TO IMPLANT SIX HELI-FX ENDOANCHORS IN ONE ENDOGRAFT TO ANOTHER ENDOGRAFT TO THE DISTAL NECK OUT OF CONCERN FOR LATE FAILURE. THE ANEURYSM EXTENDED FROM THE VISCERAL AORTA TO THE SUPRARENAL ABDOMINAL AORTA. THE MAXIMUM ANEURYSM DIAMETER MEASURED 66 MM. THE DIAMETER OF THE AORTA AT THE SUPERIOR MESENTERIC ARTERY MEASURED 32 MM IN DIAMETER. THE DIAMETER IMMEDIATELY PROXIMAL TO THE ANEURYSM MEASURED 32 MM. THE PROXIMAL NECK LENGTH MEASURED 45 MM AND THE DISTAL NECK LENGTH MEASURED 20 MM. THERE WAS NO VESSEL TORTUOSITY, THERE WAS NO THROMBUS AT THE PROXIMAL SEAL ZONE, AND THERE WAS NO CALCIUM AT THE PROXIMAL SEAL ZONE. THERE WAS LOCALIZED CALCIUM AT THE DISTAL SEAL ZONE THAT COVERED 40% OF THE CIRCUMFERENCE WITH A MAXIMUM THICKNESS OF 1.5 MM. IT WAS REPORTED THAT, A CT REVEALED THAT THE VALIANT STENT GRAFT HAD A PROXIMAL TYPE I ENDOLEAK. THE MAXIMUM DIAMETER OF THE ANEURYSM MEASURED 62 MM. THE PATIENT WAS HOSPITALIZED AND, THE PHYSICIAN ELECTED TO IMPLANT A VALIANT 42X42X200 STENT GRAFT PROXIMALLY. THE STENT GRAFT EXTENSION WAS ADVAN

  Patient problems: Injury

  MAUDE report 6992599 ↗
• InjuryAug 30, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF 60MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY UNDER THE CARE OF ANOTHER PHYSICIAN AND WAS FOUND TO HAVE A DISSECTION EXTENDING PROXIMALLY FROM THE STENT GRAFT TO THE SUBCLAVIAN ARTERY. THE PHYSICIAN STATED THAT THEY WOULD MEDICALLY MANAGE THE PATIENT AND DETERMINE IF AN LSA BYPASS IS NEEDED ALONG WITH A PROXIMAL STENT GRAFT EXTENSION. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS DUE TO UNCONTROLLED HYPERTENSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THEIR PHYSICIAN.

  Patient problems: Vascular Dissection

  MAUDE report 6829545 ↗
• InjuryFeb 21, 2017Adverse 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 9.0 CM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY WITH ACUTE ONSET PARALYSIS. THE PATIENT WILL NOT BE RECEIVING ANY TREATMENT. THE PHYSICIAN STATED THAT THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Paralysis

  MAUDE report 6347987 ↗