VALIANT® Captivia VAMF3434C150TU (UDI 00643169346970)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169346970), received between Apr 22, 2017 and Dec 5, 2025 — classified as 12 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2025Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA . THE STENT GRAFT WAS IMPLANTED COVERING THE LSA AND THE PROCEDURE WAS COMPLETED AS PLANNED. TWO SENTRANT SHEATHS WERE ALSO USED DURING THE PROCEDURE. A CT PERFORMED 31 DAYS LATER SHOWED A SMALL ENDOLEAK. THE PATIENT HAD RETROGRADE FLOW INTO THE LSA. THE PATIENT UNDERWENT COIL EMBOLIZATION A MONTH LATER. THREE DAYS POST THIS PROCEDURE , THE PATIENT PRESENTED TO ED WITH HEMATEMESIS. A CT SCAN SHOWED A PAU AT THE DISTAL AORTIC ARCH. A VALIANT CAPTIVIA WAS THEN IMPLANTED THE FOLLOWING DAY. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. A CT 10 DAYS LATER SHOWED A PERSISTENT ENDOLEAK. THE PATIENT PRESENTED TO A DIFFERENT ED FIVE DAYS LATER FOR A SECOND OPINION. THE PATIENT WAS ADMITTED AND HAD THREE STENT GRAFTS IMPLANTED. THE PATIENT WAS DISCHARGED AND FOLLOWED UP IMAGING SHOWED COMPLETE RESOLUTION OF THE ENDOLEAK. THE SPONSOR ASSESSED THE PAU AND ENDOLEAK AS POSSIBLY RELATED TO THE STENT GRAFT DEVICE, NOT RELATED TO THE STUDY PROCEDURE. THE SITE ASSESSED THE PAU AS NOT RELATED TO THE PROCEDURE. THE ENDOLEAK OBSERVED ONE MONTH AFTER THE INDEX PROCEDURE FOLLOWED BY COIL EMBOLIZATION WAS IDENTIFIED AS TYP

  Patient problems: Insufficient Information

  MAUDE report 23726339 ↗
• InjuryOct 15, 2025Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA. THE STENT GRAFT WAS IMPLANTED COVERING THE LSA AND THE PROCEDURE WAS COMPLETED AS PLANNED. TWO SENTRANT SHEATHS WERE ALSO USED DURING THE PROCEDURE. A CT PERFORMED ONE MONTH LATER SHOWED A SMALL ENDOLEAK. THE PATIENT HAD RETROGRADE FLOW INTO THE LSA. THE PATIENT UNDERWENT COIL EMBOLIZATION A MONTH LATER. THREE DAYS LATER, THE PATIENT PRESENTED TO ED WITH HEMATEMESIS. A CT SCAN SHOWED A PAU AT THE DISTAL AORTIC ARCH. A DISTAL TEVAR EXTENSION WAS THEN IMPLANTED THE FOLLOWING DAY. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. A CT TWO WEEKS LATER SHOWED A PERSISTENT ENDOLEAK. THE PATIENT PRESENTED TO A DIFFERENT ED FIVE DAYS LATER FOR A SECOND OPINION. THE PATIENT WAS ADMITTED AND HAD THREE STENT GRAFTS IMPLANTED. THE PATIENT WAS DISCHARGED A WEEK LATER AND FOLLOWED UP IMAGING SHOWED COMPLETE RESOLUTION OF THE ENDOLEAK. THE SPONSOR ASSESSED THE PAU AND ENDOLEAK AS POSSIBLY RELATED TO THE STENT GRAFT DEVICE, NOT RELATED TO THE STUDY PROCEDURE. THE SITE ASSESSED THE PAU AS NOT RELATED TO THE PROCEDURE.

  Patient problems: Hematemesis; Pseudoaneurysm; Ulcer

  MAUDE report 23298869 ↗
• InjuryFeb 20, 2025Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED FOR THE TREATMENT OF A TYPE B THORACIC AORTIC DISSECTION. NO DAMAGE WAS NOTED TO THE DEVICE OR DEVICE BOX PRIOR TO THE PROCEDURE. IT WAS NOTED THAT PRIOR TO DEPLOYMENT, IVUS AND ANGIOGRAPHY WERE PERFORMED. THE PHYSICIAN COULD SEE THE INNOMINATE, LEFT CAROTID AND LEFT SUBCLAVIAN, BUT COULD NOT IDENTIFY THE CELIAC TRUNK AND THE RIGHT RENAL ARTERY WAS ALREADY OUT BEFORE THE PROCEDURE STARTED. THE VALIANT CAPTIVIA WAS INITIALLY INTENDED TO LAND AT THE LEFT CAROTID. THE GRAFT WAS ADVANCED TO THE DESIRED LANDING AREA AND THERE WAS ABOUT 1CM LANDING ZONE AT THE LEFT CAROTID ARTERY. WHILE THE STENT WAS BEING DEPLOYED, IT KICKED BACK AND LANDED AT THE LEFT SUBCLAVIAN ARTERY. IT WAS CONFIRMED THAT THE DEPLOYMENT STEPS WERE FOLLOWED PER THE INSTRUCTIONS FOR USE. SUBSEQUENT ANGIOGRAPHY SHOWED THAT THE GRAFT WAS IN THE FALSE LUMEN. THE PHYSICIAN BELIEVES THAT THE GRAFT WAS DEPLOYED IN THE FALSE LUMEN AFTER THE WIRE CROSSED OVER FROM THE TRUE TO THE FALSE LUMEN BEFORE DEPLOYMENT. NO I NTERVENTION WAS PERFORMED. IT WAS NOT POSSIBLE TO REPOSITION THE STENT AS IT WAS DEPLOYED IN THE FALSE LUMEN. THE DEVICE REMAINS IMPLANTED. THE

  Patient problems: Necrosis; Pulmonary Edema

  MAUDE report 21418846 ↗
• InjuryJan 23, 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 DISTAL PAU AND IMH. IT WAS REPORTED POST THE INDEX PROCEDURE, THE PATIENT HAD AN UNEVENTFUL COURSE. FOLLOW-UP CTA 4 DAYS LATER DID NOT SHOW ANY EVIDENCE OF A TYPE A DISSECTION. REPEAT CTA ANOTHER 12 DAYS LATER DID NOT REVEAL ANY TYPE A DISSECTION AT THAT TIME. THE PATIENT THEN PRESENTED EMERGENTLY TO THE ER ANOTHER 18 DAYS LATER WITH COMPLAINTS OF NOT FEELING WELL, FATIGUE, AND WAS FOUND TO BE HYPOTENSIVE. A CTA AND TEE WERE PERFORMED WHICH SHOWED A TYPE A DISSECTION. ON THE SAME DAY THE PATIENT WAS TAKEN TO OR AND UNDERWENT AN SURGICAL AORTIC ROOT REPAIR. THIS RESOLVED THE DISSECTION. IT WAS REPORTED THE STENT GRAFT WITH SN (B)(4) IS THE MOST PROXIMAL STENT GRAFT. THE OTHER STENT GRAFT (B)(4) WAS PLACED SECOND AND MOST DISTAL AND THERE IS NO REASON TO BELIEVE THIS STENT GRAFT WAS INVOLVED AT ALL IN THE RTAD. PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Low Blood Pressure/ Hypotension; Vascular Dissection

  MAUDE report 16223643 ↗
• InjuryOct 19, 2022Adverse Event Without Identified Device or Use Problem; 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 , WHERE A RTAD WAS DIAGNOSED. THE PATIENT THEN UNDERWENT AN OPEN REPAIR.  PER THE PHYSICIAN THE CAUSE OF HE RTAD WAS THE PROXIMAL BARE SPRING PENETRATING THE LESSER CURVE OF ARCH WHERE THE SUPRARENAL STENTS  HAD BEEN PLACED PROXIMAL TO LSA.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Vascular Dissection

  MAUDE report 15630519 ↗
• MalfunctionAug 16, 2022Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  A VALIANT CAPTIVIA STENT GRAFT WAS INTENDED TO BE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60MM TAA. IT WAS REPORTED WHEN REMOVING THE DEVICE FROM THE PACKAGING TRAY, THE BLUE TIP CAPTURE HANDLE CAME APART. ANOTHER DEVICE WAS OPENED AND USED INSTEAD. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS A DEVICE FAILURE WHILE PREPPING THE DEVICE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15231126 ↗
• InjuryMar 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTA ULCER .  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH CHEST PAIN AND SHORTNESS OF BREATH. A CTA REVEALED A RETROGRADE TYPE A DISSECTION WITH FLUID IN THE PERICARDIUM. THE PATIENT WAS IMMEDIATELY TAKEN TO SURGERY WERE THE PATIENT UNDERWENT AN ASCENDING AND AORTIC ARCH REPLACEMENT WITH REIMPLANTATION OF INNOMINANT, RIGHT COMMON CAROTID, AND LEFT SUBCLAVIAN ARTERY. THE PHYSICIAN REMOVED THE FREE FLOW STENT WITH WIRE CUTTERS AND SEWED THE GRAFT TO THE AORTA JUST PROXIMAL TO THE REMAINING STENT GRAFT. AS PER THE PHYSICIAN THE CAUSE OF THE DISSECTION WAS DUE TO THE FREE FLOW STENT. THIS WAS CONFIRMED DURING THE INTERVENTION AND ON CT. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Dyspnea; Pain; Vascular Dissection

  MAUDE report 13900030 ↗
• InjuryOct 18, 2021Adverse 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 NEW ENTRY DISSECTION ON (B)(6) 2021. THIS PATIENT HAD 2 VALIANT NAVIONS IMPLANTED THE YEAR PREVIOUSLY TO TREAT A DISSECTION. THIS NEW ENTRY TEAR OCCURRED BELOW THE NAVION GRAFTS.  IT WAS REPORTED DURING THE PROCEDURE, THE PHYSICIAN RELINED THE NAVION STENT GRAFTS WITH THE VALIANT CAPTIVIA AND EXTENDED TO THE CELIAC ARTERY. IT WAS DISCOVERED 2 DAYS LATER THE PATIENT WAS FOUND TO BE PARALYZED.  AS PER THE PHYSICIAN THE CAUSE OF THE PATIENTS PARALYSIS MAY HAVE BEEN DUE TO COVERING A SET OF LUMBERS RIGHT ABOVE THE CELIAC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Obstruction/Occlusion; Paralysis

  MAUDE report 12645895 ↗
• InjuryOct 3, 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 THORACIC ENDOVASCULAR TREATMENT OF A COMPLICATED TYPE B DISSECTION. IT WAS REPORTED THAT THE FOLLOWING MORNING THE PATENT EXPERIENCED PAIN AND A CT SCAN IDENTIFIED A RETROGRADE TYPE A DISSECTION. THE PHYSICIAN PERFORMED FURTHER SURGERY. AN ASCENDING AORTA AND AORTIC ARCH REPLACEMENT WAS CARRIED OUT WITH DEBRANCHING OF THE INNOMINATE AND LEFT CAROTID ARTERIES. THE TREATMENT WAS SUCCESSFULLY COMPLETED AND THE EVENT WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO PATIENT ANATOMY-COMPLICATED ACUTE TYPE B DISSECTION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Intimal Dissection; Pain

  MAUDE report 7929362 ↗
• InjuryJun 26, 2018Difficult to Advance; Difficult to Advance

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 70 MM THORACOABDOMINAL ANEURYSM. CALCIFI CATION 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 PL

  Patient problems: Rupture

  MAUDE report 7636999 ↗
• InjuryOct 20, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED INTO A PATIENT FOR THE EMERGENT ENDOVASCULAR TREATMENT OF A LEAKING DESCENDING THORACIC AORTIC ULCER. IT WAS REPORTED THAT THE PATIENT PRESENTED WITH CHEST PAIN. AN ANGIOGRAM REVEALED THAT THERE WAS A RETROGRADE TYPE A DISSECTION FROM THE SUPRARENAL STRUTS EXTENDING INTO THE ASCENDING AORTA DOWN TO THE LEVEL OF THE SINOTUBULAR JUNCTION. THE PATIENT HAS UNCONTROLLED HYPERTENSION AND THIS WAS CONTROLLED WITH NICARDIPINE. THE PHYSICIAN PREFORMED OPEN SURGICAL REPAIR FOR THE TYPE A DISSECTION. A DACRON GRAFT WAS SEWN INTO THE AORTA, THEN THE AORTA WAS CUT AND TRIMMED PROXIMALLY TO THE SINOTUBLAR JUNCTION WHICH WAS RECONSTRUCTED WITH A DOUBLE FELT SANDWICH THAT WAS SEWN IN PLACE AND WITH BYPASS OF THE INNOMINATE ARTERY AND THE LEFT CAROTID ARTERY. PER THE OPERATIVE REPORT THAT CAUSE OF THE RETROGRADE TYPE A DISSECTION WAS DUE TO THE COMBINATION OF THE PATIENT¿S TISSUE QUALITY THAT WAS PARTICULARLY FRIABLE AND VERY POOR AND TO THE BARBS OF THE STENT GRAFT. PER THE PHYSICIAN, THE CAUSE OF THE EVENT MAY HAVE BEEN DUE TO OVER SIZING OF THE VALIANT STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: High Blood Pressure/ Hypertension; Vascular Dissection

  MAUDE report 6964301 ↗
• InjuryMay 30, 2017Break; Difficult To Position; Device Damaged by Another Device; Break; Difficult To Position; Device Damaged by Another Device

  A VALIANT STENT GRAFT SYSTEM WAS INSERTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5.5 CM IN DIAMETER THORACIC AORTIC ANEURYSM. AN ENDURANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR USE AS A CONDUIT IN THE RIGHT ILIAC LIMB. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO ADVANCE THE VALIANT 34X34X150 DELIVERY SYSTEM TO THE INTENDED LANDING ZONE DUE TO CALCIFICATION. THE VALIANT 34X34X150 WAS REMOVED FROM THE PATIENT. THE PHYSICIAN ELECTED TO IMPLANT AN ENDURANT 16X10X124 RIGHT ILIAC LIMB IN THE RIGHT COMMON AND EXTERNAL ILIAC ARTERIES AS A CONDUIT. THE PHYSICIAN USED ANOTHER MANUFACTURER¿S 12X4 BALLOON IN THE ENDURANT STENT GRAFT AND PERFORMED AN ANGIOPLASTY. THE PHYSICIAN RE-INSERTED THE VALIANT 34X34X150 ONCE AGAIN, BUT WAS UNABLE TO ADVANCE THE DEVICE, THE PHYSICIAN NOTICED THAT THE NOSE CONE HAD BEEN DAMAGED WITH WHAT APPEARED TO BE A BURR ON THE END. THE DEVICE WAS DISCARDED. THE PHYSICIAN INSERTED A VALIANT 34X34X200 STENT GRAFT HOWEVER WHILE ADVANCING THE DEVICE UP THE LEFT ILIAC ARTERY THERE WAS SOME FRICTION THE DEVICE THEN KINKED/BUCKLED AND THEN WAS UNABLE TO ADVANCE ANY FURTHER. THE PHYSICIAN REMOVED AND DISCARDED THE DEVICE AND ABORTED PROCEDURE. AFT

  Patient problems: Injury

  MAUDE report 6599596 ↗
• InjuryApr 22, 2017Difficult To Position; Device Damaged by Another Device; Difficult To Position; Device Damaged by Another Device

  A VALIANT STENT GRAFT SYSTEM WAS SELECTED FOR USE IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 6.5 CM IN DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT PRIOR TO THE PROCEDURE THE CTA HAD NO ACCESS VESSELS VISUALIZED AND WAS NOTED IN THE 3D REPORT. DAY OF PROCEDURE PHYSICIAN WAS NOTIFIED AGAIN OF NO ACCESS VESSEL VISUALIZED ON CTA. DURING PROCEDURE, A BARE METAL STENT WAS SEEN IN THE MID-RIGHT EXTERNAL ILIAC ARTERY. THE VALIANT DELIVERY SYSTEM WAS INSERTED BUT COULD NOT ADVANCE THROUGH BARE METAL STENT. THE VALIANT DELIVERY SYSTEM WAS REMOVED FROM THE PATIENT. THE PHYSICIAN ELECTED TO ANGIOPLASTY/BALLOON TO EXPAND THE BARE METAL STENT. THE VALIANT DELIVERY SYSTEM WAS ATTEMPTED AGAIN BUT COULD NOT GO THROUGH BARE MENTAL STENT. THE VALIANT STENT GRAFT WAS REMOVED FROM THE PATIENT. THE PHYSICIAN ELECTED TO END THE PROCEDURE. IT WAS REPORTED THAT POST PROCEDURE THE PATIENT DEVELOPED A COLD RIGHT LEG. THE PATIENT HAD A CUT DOWN RIGHT GROIN AND THERE WAS A PERFORATION/DISSECTION IN THE RIGHT EXTERNAL ILIAC ARTERY. THE PHYSICIAN IMPLANTED A BARE MENTAL STENT IN THE RIGHT EXTERNAL ILIAC ARTERY AND THE RIGHT COMMON ILIAC ARTERY WHICH SEALED THE PERFORATION/DISSECTION. PER THE PH

  Patient problems: Perforation of Vessels

  MAUDE report 6514034 ↗