VALIANT® Captivia VAMF4646C150TURecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00643169346918), received between Dec 2, 2016 and Nov 15, 2023 — classified as 3 deaths, 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2023Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN UNKNOWN TYPE ENDOLEAK. THE PATIENT HAD 3 EXISTING VALIANT NAVION STENT GRAFTS IMPLANTED APPROXIMATELY 1 YEAR PREVIOUS FOR A A 55MM THORACIC AORTIC ANEURYSM. POST THE IMPALNT OF THE VALIANT CAPTIVIA THE ENDOLEAK WAS CONFIRMED AS RESOLVED. VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 55MM THORACIC AORTIC ANEURYSM ON THE (B)(6) 2020. IT WAS REPORTED FOLLOW UP CT WITH CONTRAST 9 MONTHS POST THE VALIANT CAPTIVA IMPLANT ON 29 WAS NOTABLE FOR TYPE IIIA ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18138248 ↗
• MalfunctionAug 4, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTIC ANEURYSM. AN ADDITIONAL VALIANT STENT GRAFT (46X46X150) WAS IMPLANTED APPROXIMATELY 1 YEAR LATER TO TREAT A TYPE IB ENDOLEAK IN VNMC4343C218TY(V29775349) WHICH WAS CONFIRMED AS RESOLVED. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THE PATIENT RETURNED FOR A FOLLOW-UP CT WHERE A TYPE IB ENDOLEAK WAS OBSERVED AND THE ANEURYSM SAC MEASURED 76MM. THE PHYSICIAN IS UNABLE TO DETERMINE WHICH DEVICE CONTAINS THE ENDOLEAK. NO CAUSE OF THE EVENT AS PER THE PHYSICIAN WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm; No Clinical Signs, Symptoms or Conditions; Pseudoaneurysm

  MAUDE report 15162064 ↗
• DeathJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A DISSECTION OF THE ENTIRE DESCENDING AORTA MEASURING APPROXIMATELY 300MM IN LENGTH. IT WAS REPORTED ON AN UNKNOWN DATE POST THE INDEX PROCEDURE THAT THE PATIENT WAS RECOVERING AT HOME. THE PATIENT COMPLAINED OF A HEADACHE AND WENT TO LAY DOWN. THE PATIENT'S DAUGHTER CHECKED ON THE PATIENT APPROXIMATELY 30 MINUTES LATER AND FOUND THE PATIENT DECEASED. AN AUTOPSY WAS REFUSED AND THE POLICE REPORT STATED THAT THE PATIENT DIED OF SURGICAL CAUSES.  PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AND THE PATIENT HAS EXPIRED.

  Patient problems: Headache; Insufficient Information

  MAUDE report 14641887 ↗
• InjuryMay 23, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A HELI-FX ENDOANCHORING SYSTEM WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE IN ORDER TO TREAT A TYPE IA ENDOLEAK ON EXISTING VALIANT CAPTIVIA STENT GRAFTS. IT WAS REPORTED DURING THE INDEX PROCEDURE ONE ENDOANCHOR DID NOT PENETRATE THE AORTIC WALL AND BECAME LOOSE IN THE DESCENDING AORTA. THE PHYSICIAN PLACES ANOTHER GRAFT OVER IT TO HOLD IT IN PLACE AND THE ISSUE WAS RESOLVED.  AS PER THE PHYSICIAN THE CAUSE OF THE INACCURATE DELIVERY WAS AS A RESULT OF THE PATIENTS ANATOMY.  PER THE PHYSICIAN THE CAUSE OF TYPE IA ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14469231 ↗
• MalfunctionJun 22, 2021Difficult to Remove; Material Deformation; Difficult to Remove; Material Deformation

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 55 MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, DIFFICULTIES TO REMOVE THE DELIVERY SYSTEM WAS ENCOUNTERED DUE TO A TIGHT ARCH. IT WAS STATED THAT AFTER SEVERAL TROUBLESHOOTING MANEUVERS THE DEVICE WAS PULLED BACK, HOWEVER ONE OF THE BARE STENTS WERE INVERTED. AN ATTEMPT WAS THEN PERFORMED TO BALLOONING AND STRAIGHTEN THE DEVICE WITHOUT SUCCESS. A CT WAS PERFORMED, WHERE THE INVERTED STENT WAS CONFIRMED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PATIENT'S ANATOMY DUE TO A HOSTILE ARCH. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12041837 ↗
• InjuryOct 31, 2018Difficult or Delayed Positioning; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem; Difficult or Delayed Positioning; Inadequacy of Device Shape and/or Size; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 58MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE AFTER THE DEPLOYMENT OF THE DEVICE THE DELIVERY SYSTEM GOT STUCK IN THE EXTERNAL ILIAC. IT WAS STATED THAT THE PHYSICIAN PERFORMED A CUT DOWN AT THE AREA WHERE THE DELIVERY SYSTEM WAS STUCK. THE DELIVERY SYSTEM WAS REMOVED AND THE ARTERY WAS REPAIRED WITH A SYNTHETIC GRAFT. THE EVENT WAS RESOLVED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO PATIENT'S ANATOMY; PATIENTS ARTERY WAS TOO SMALL FOR THE SIZE OF THE DELIVERY SYSTEM. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Intimal Dissection

  MAUDE report 8024012 ↗
• MalfunctionDec 11, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A VALIANT CAPTIVA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 61MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE DEVICE WAS TRACKED TO WITHIN 4CM OF THE DESIRED PROXIMAL SEAL LOCATION AND A PRE-DEPLOYMENT ANGIOGRAM WAS TAKEN. FORWARD MOVEMENT OF THE DEVICE WAS DIFFICULT BECAUSE THE PREVIOUSLY IMPLANTED SYNTHETIC ASCENDING ARCH REPLACEMENT GRAFT WAS PLIABLE AND MOVED ALONG WITH THE FORWARD PRESSURE APPLIED TO THE VALIANT STENT GRAFT. IN ADDITION TO THIS, THE HYPOTUBE OF THE DELIVERY SYSTEM WAS BENDING AS FORWARD PRESSURE WAS BEING APPLIED AND THE NOSECONE WAS HELD IN A DOWNWARD POSITION AS IT ENTERED THE STEEP ASCENDING REPAIR, PUTTING IT AT A DIFFICULT DEPLOYMENT ANGLE. ONCE THE MAIN PORTION OF THE DEVICE WAS DEPLOYED, THE PHYSICIAN ATTEMPTED TO DEPLOY THE TIP CAPTURE MECHANISM OF THE DEVICE. THERE WAS AN EXTREME AMOUNT OF TENSION ON THE DEPLOYMENT QUICK RELEASE AND IT WAS IMPOSSIBLE TO ADVANCE THE NOSECONE. THE DEVICE DELIVERY SYSTEM WAS THEN BROKEN DOWN ON THE BACK TABLE AS PER THE IFU TO GAIN ACCESS TO THE RELEASE KNOB ON THE NOSE CONE. THE QUICK RELEASE WAS THEN ROTATED IN A CLOCKWISE DIRECTION TO M

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7103613 ↗
• DeathNov 28, 2017Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTIC ANEURYSM. THE DIAMETER CAUDAL TO THE LEFT CAUDAL ARTERY WAS 34.0/34.9MM AND DIAMETER CAUDAL TO THE LEFT SUBCLAVIAN ARTERY 31.7/34.9MM. IT WAS REPORTED THAT THE PATIENT PRESENTED APPROXIMATELY 16 MONTHS POST INDEX PROCEDURE WITH A TYPE I ENDOLEAK. DURING A RE-INTERVENTION THE STENT GRAFT WAS EXTENDED PROXIMALLY AND BALLOONED HOWEVER, IT WAS NOTED THAT THERE WAS A BLUSH AT THE END OF THE CASE INDICATING THE ENDOLEAK WAS STILL PRESENT. A SCAN WAS DONE FEW DAYS LATER THAT SHOWED AN ENDOLEAK STILL PRESENT; HOWEVER, IT WAS REPORTED THAT THE PATIENT DIED 2 MONTHS LATER AND THE PHYSICIAN STATED THE CAUSE OF DEATH WAS DUE TO AN MI. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Myocardial Infarction

  MAUDE report 7062658 ↗
• InjuryOct 23, 2017Leak/Splash; Leak/Splash

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL ANEURYSM. IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY IMPLANTED THE VALIANT STENT GRAFT ALONG WITH SUPERIOR MESENTERIC ARTERY (SMA) AND LEFT RENAL ARTERY WITH THE SNORKEL TECHNIQUE. THE PHYSICIAN MODELLED THE VALIANT STENT GRAFT WITH BALLOONING HOWEVER THE AORTOGRAM REVEALED A TYPE IA ENDOLEAK. THE PHYSICIAN ELECTED TO SNORKEL THE CELIAC ARTERY, LENGTHEN THE SMA STENT AND THE LEFT RENAL ARTERY STENT AND IMPLANTED A 2ND VALIANT STENT GRAFT HIGHER IN THE DESCENDING THORACIC AORTA. ALL DEVICES WERE PLACED SUCCESSFULLY. BALLOONING WAS COMPLETED HOWEVER THE AORTOGRAM REVEALED THAT THE TYPE IA ENDOLEAK WAS STILL PRESENT. PER THE PHYSICIAN, THE CAUSE OF THE PROXIMAL TYPE I ENDOLEAK WAS DUE TO THE PATIENT¿S ANATOMY, THORACOABDOMINAL ANEURYSM. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED BY THE PHYSICIAN.

  Patient problems: Injury

  MAUDE report 6967940 ↗
• InjuryFeb 23, 2017Malposition of Device; Activation, Positioning or Separation Problem; Malposition of Device; Activation, Positioning or Separation Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF CHRONIC DISSECTION WITH A 6 CM IN DIAMETER THORACIC AORTA ANEURYSM. THE PATIENT HAD A PRIOR ASCENDING THORACIC ARCH REPAIR THAT HAS DEVELOPED A CHRONIC DISSECTION MEASURING 44-45MM ON CT SCAN. THE PHYSICIAN PREFORMED A LEFT SUBCLAVIAN TRANSPOSITION PRIOR TO THE CASE. THE PHYSICIAN IMPLANTED VALIANT 42X42X150 STENT GRAFTS AT THE LEVEL OF THE CELIAC ARTERY, EXTENDING PROXIMAL WITH A VALIANT 46X46X200, EXTENDING PROXIMALLY WITH VALIANT 46X46X150. DURING THE DEPLOYMENT OF THE VALIANT 46X46X150 AT THE LEVEL OF THE LEFT CAROTID ARTERY THE VALIANT STENT GRAFT MOVED BACK 1CM FROM THE INTENDED LANDING ZONE. THE FIRST STENT WAS NOT FULLY DEPLOYED SO THE VALIANT STENT GRAFT WAS ADVANCED FORWARD. AS THE PHYSICIAN CONTINUED TO DEPLOY THE INNER CURVE OF THE STENT GRAFT USING THE QUICK DEPLOYMENT METHOD, IT WAS INADVERTENTLY CAUGHT ON THE BARE METAL STENT OF THE VALIANT 46X46X200. AS A RESULT THE STENT GRAFT WAS PUSHED FORWARD COVERING THE LEFT CAROTID ARTERY. THE DELIVERY SYSTEM WAS REMOVED, THE PATIENT WAS GIVEN MORE BLOOD THINNING MEDICATION (HEPARIN). THE PHYSICIAN WAS ABLE TO INSERT ANOTHER MANUFACTURER

  Patient problems: Injury

  MAUDE report 6355165 ↗
• DeathDec 2, 2016Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 76 MM IN DIAMETER THORACIC AORTIC ANEURYSM. THE PROXIMAL AORTIC NECK MEASURED FROM 27 MM TO 32 MM ALONG A 20 MM LENGTH. THE DISTAL AORTIC LANDING ZONE MEASURED FROM 38 MM TO 24 MM ALONG A 15 MM LENGTH. COVERAGE WAS EXTENDED TO THE SUPERIOR MESENTERIC ARTERY. THERE WAS NO THROMBUS OR CALCIFICATION AT THE PROXIMAL IMPLANT SITE. THERE WAS THROMBUS AT THE DISTAL LANDING ZONE. APTUS ENDOANCHORS WERE IMPLANTED AT THE DISTAL SEAL ZONE AS A PROPHYLACTIC. AN ANGIOGRAM REVEALED ADEQUATE SEAL AT THE END OF THE PROCEDURE. IT WAS REPORTED THAT FIVE DAYS POST INDEX PROCEDURE THE PATIENT WAS SCHEDULED FOR DISCHARGE BUT HAD AN ANEURYSM RUPTURE AND DIED. BLOOD WAS OBSERVED IN THE LEFT CHEST OF THE PATIENT. PER THE PHYSICIAN THE CAUSE OF THE RUPTURE WAS UNKNOWN. NO ADDITIONAL SEQUELAE WERE REPORTED.

  Patient problems: Death; Rupture

  MAUDE report 6142417 ↗