VALIANT® Captivia VAMF3232C150TU (UDI 00643169346987)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00643169346987), received between Jan 9, 2017 and Oct 4, 2024 — classified as 7 deaths, 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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.

• DeathOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE EMERGENT ENDOVASCULAR TREATMENT OF A RUPTURED THORACIC ANEURYSM. IT WAS REPORTED THAT DURING THE PROCEDURE, THE PATIENT RECEIVED OPEN DEBRANCHING AND SURGICAL GRAFT REPAIR FOLLOWED IMMEDIATELY BY E NDOVASCULAR STENT GRAFT IMPLANTATION. THE VALIANT CAPTIVIA STENT GRAFTS DEPLOYED AS EXPECTED. THE PATIENT CODED AND EXPIRED ON THE TABLE AT THE CONCLUSION OF THE SURGICAL PROCEDURE. PER THE PHYSICIAN, IT IS UNKNOWN WHAT WAS THE CAUSE OF THE DEATH AND WHETHER THE DEVICES OR PROCEDURE CONTRIBUTED.

  Patient problems: Insufficient Information

  MAUDE report 20368956 ↗
• InjuryOct 6, 2023Leak/Splash; Leak/Splash

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A  TAA .  IT WAS REPORTED ON AN UNKNOWN FOLLOW-UP VISIT , IT WAS NOTED THE PATIENTS ANEURYSM HAD ENLARGED FROM 45MM TO 80MM . THE SIZE OF THE TAA CAUSED PRESSURE ON THE PATIENTS ESOPHAGUS.  A CT PERFORMED AND A REVIEWED BY A RADIOLOGIST DETERMINED THERE WAS A TYPE III AND IB ENDOLEAK PRESENT.  INTERVENTION WAS PERFORMED , THE PATIENT WAS BROUGHT TO OR. A TYPE IB ENDOLEAK WAS NOTED THEREFORE A NON MDT STENT GRAFT WAS IMPLANTED AS A DISTAL EXTENSION.  THE PHYSICIAN NOTED A POSSIBLE FRACTURE IN VAMF3838C200TU CAUSING TYPE III ENDOLEAK. THIS STENT GRAFT WAS ALSO RELINED WITH A NON MDT STENT GRAFT.  PER THE PHYSICIAN,  THE CAUSE OF THE TYPE III ENDOLEAK WAS NOTED TO BE THE FRACTURE AND THE CAUSE OF THE IB ENDOLEAK WAS NOTED AS TAA ENLARGEMENT.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 17886059 ↗
• InjuryOct 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF TWO THORACIC ULCERS. IT WAS REPORTED THAT POST THE INDEX PROCEDURE THE PATIENT HAD A SPINAL CORD INJURY. WHEN THE PATIENT WOKE UP POST THE PROCEDURE THE PATIENT HAD LOST FEELING AND MOVEMENT IN THE LOWER EXTREMITIES. A SPINAL DRAIN WAS PLACED PRIOR TO THE PATIENT LEAVING THE OPERATING ROOM. THE ANESTHESIOLOGIST REMOVED 10-20ML OF CSF FROM THE PATIENT AND THE PATIENT STATED THEY COULD FEEL THEIR FEET HOWEVER THE PATIENT DID NOT RECOVER MOVEMENT OF THE LOWER EXTREMITIES. PER THE PHYSICIAN THE CAUSE OF THE SPINAL CORD INJURY WAS RELATED TO THE PATIENT'S ANATOMY AND THE TWO THORACIC ULCERS. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; Spinal Column Injury

  MAUDE report 17859097 ↗
• InjuryAug 22, 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 TOTAL AORTIC DISSECTION .  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH A RETROGRADE TYPE A DISSECTION. THE PATIENT WAS FLOWN TO ANOTHER FACILITY WHERE THE RTAD WAS REPAIRED. ON THE SAME DATE THE PATIENT HAD A CHEST TUBE REMOVED AND EXPERIENCED A HYPOTENSIVE EVENT.  PER THE PHYSICIAN THE CAUSE OF THE RTAD COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Low Blood Pressure/ Hypotension; Vascular Dissection

  MAUDE report 17594709 ↗
• DeathSep 15, 2022Leak/Splash; Leak/Splash

  A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A RUPTURED THORACIC AORTIC DISSECTION AND TAA.   IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED AFTER A NON MDT BALLOON WAS USED TO OPEN THE TRUE LUMEN. A FINAL ANGIOGRAM PERFORMED SHOWED A TYPE IV ENDOLEAK. INTERVENTION WAS PERFORMED AND THE PHYSICIAN IMPLANTED ANOTHER VALIANT CAPTIVA BUT THE ENDOLEAK WAS STILL REMAINING. ANOTHER  VALIANT CAPTIVIA WAS THEN IMPLANTED AND THE ENDOLEAK WAS STILL PRESENT. THE PHYSICIAN THEN CONVERTED TO OPEN SURGICAL REPAIR AND SUTURED A PATCH ON THE VALIANT CAPTIVIA. THE ENDOLEAK RESOLVED BUT AFTER THE PATIENT WAS FOUND TO HAVE A MORE DISTAL DISSECTION AND THEN EXPIRED THE FOLLOWING DAY.  NO CAUSE OF THE EVENT WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Heart Failure/Congestive Heart Failure; Insufficient Information

  MAUDE report 15425803 ↗
• DeathAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA DEVICES WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED ABOUT 7 WEEKS LATER FOLLOW UP CT A TYPE IA ENDOLEAK WAS IDENTIFIED ON DEVICE VAMF3030C200 ((B)(4)). 8 DAYS LATER 2 VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED WITH NO ISSUE TO REPAIR THE TYPE IA ENDOLEAK. THE PHYSICIAN WANTED TO DO A LASER FENESTRATION OF THE LEFT SUBCLAVIAN ARTERY. THE GRAFT WAS PLACED AT THE LEVEL OF THE LEFT CAROTID ARTERY AND BALLOONED WITH A RELIANT TO THE APPROPRIATE DIAMETER. THE PHYSICIAN HAD A DIFFICULT TIME WITH LASER FENESTRATION OF THE LSA WITH MULTIPLE ATTEMPTS MADE BUT IT WAS UNCERTAIN IF THE PHYSICIAN WAS INSIDE OF THE VALIANT GRAFT. ANESTHESIA STATED THAT THE PATIENT'S CONDITION WAS NOT DOING WELL. THE PHYSICIAN DECIDED TO DO AN ANGIOGRAM WHERE NO TYPE A DISSECTION (ASCENDING) AND NO EXTRAVASATION IN THE THORACIC AORTA WAS SEEN. IVUS WAS LOOKED AT WITH NO EVIDENCE OF RUPTURE OR DISSECTION. CPR WAS INITIATED FOR A PERIOD OF TIME. ANESTHESIA DID A TEE AND SAW A PERICARDIAL EFFUSION AND BLOOD IN THE CHEST. THE PHYSICIAN PUT IN A CHEST TUBE AND CHEST COMPRESSION CONTINUED TO NO AVAIL. A RELIANT BALLOON WAS INFLATED TO TAMPONADE THE AORTA IN THE ARCH TO SEE

  Patient problems: Perforation; Pericardial Effusion

  MAUDE report 15232257 ↗
• DeathMay 30, 2022Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. A VALIANT NAVION GRAFT WAS IMPLANTED 3 MONTHS LATER DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. A VALIANT CAPTIVIA WAS IMPLANTED 16 MONTHS LATER. THREE VALIANT NAVIONS WERE IMPLANTED AS PART OF A REINTERVENTION FOR PRIOR AORTIC REPAIR APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT WAS COMPLETED AFTER THE PATIENT BECAME UNWELL. A TYPE II ENDOLEAK AND MULTIPLE UNKNOWN ENDOLEAKS WERE OBSERVED. NEW ANEURYSMAL DEGENERATION OF THE TEVAR AT THE PROXIMAL PART WAS NOTED WHICH RESULTED IN AN ENDOLEAK REQUIRING PROXIMAL EXTENSION. DIFFERENTIAL DIAGNOSIS INCLUDED AORTIC RUPTURE VS. EMBOLIC INFARCT TO THE SPLEEN. IT WAS REPORTED THE PATIENT EXPIRED THE DAY AFTER THE CT. AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS DUE TO MULTIPLE CAUSES - INFARCTION, INFECTION AND AORTIC RUPTURE. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Embolism/Embolus; Insufficient Information; Rupture; Unspecified Infection

  MAUDE report 14539961 ↗
• DeathJun 28, 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 50MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, DELIVERY DEPLOYMENT AND REMOVAL OF THE DELIVERY SYSTEM WAS COMPLETED SUCCESSFULLY. SUBSEQUENTLY, THE PATIENT LOST A MODERATE AMOUNT OF FLUID/BLOOD WHICH LED TO A MYOCARDIAL INFARCTION, CARDIAC ARREST AND DEATH. PER THE PHYSICIAN, THE CAUSE OF THE DEATH WAS DUE TO LOW PATIENT FLUID/BLOOD VOLUME AFTER BLOOD LOSS DURING THE PROCEDURE AND SUBSEQUENT MI LEADING TO DEATH. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

  Patient problems: Blood Loss; Cardiac Arrest; Death; Myocardial Infarction

  MAUDE report 7644868 ↗
• MalfunctionMar 20, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 78MM DISSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE TIP CAPTURE RELEASE HANDLE WOULD NOT TURN TO DEPLOY THE TIP CAPTURE OF THE DELIVERY SYSTEM. IT WAS NOTED THAT AFTER MULTIPLE EVENTS, THE PROXIMAL BARE SPRINGS WERE RELEASED AND THE EVENT WAS RESOLVED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7353515 ↗
• MalfunctionOct 20, 2017Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A VALIANT STENT GRAFT SYSTEM WAS IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT THE INITIAL DEPLOYMENT OF THE VALIANT STENT GRAFT IN THE TRANSVERSE THORACIC AORTA WAS SUCCESSFUL. WHEN THE PHYSICIAN TURNED THE HANDLE OF DELIVERY CATHETER TO RELEASE THE SUPRARENAL STRUTS, THE TIP CAPTURE RELEASE DID NOT FUNCTION. THE PHYSICIAN DISASSEMBLED THE BACK OF THE DELIVERY CATHETER AND WAS ABLE TO RELEASE THE SUPRARENAL STRUTS. THE VALIANT STENT GRAFT WAS SUCCESSFULLY IMPLANTED. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO THE DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6964161 ↗
• InjuryApr 17, 2017Migration or Expulsion of Device; Migration or Expulsion of Device

  A VALIANT CAPTIVIA STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ULCER. IT WAS REPORTED THAT THE PATIENT HAD A HYPERTENSIVE EPISODE WHICH CAUSED THE DEVICE TO MIGRATE. THE DEVICE ORIGINALLY MEASURED 32 X 32 X 150 AND WAS LANDED AT THE LEFT COMMON CAROTID ARTERY. AFTER THE HYPERTENSIVE EPISODE, THE DEVICE WAS BEHIND THE ORIGIN OF THE LEFT SUBCLAVIAN ARTERY. THERE WAS ALSO A DISSECTION THAT STARTED APPROXIMATELY 2 CM BELOW THE DISTAL EDGE OF THE STENT GRAFT. THE PHYSICIAN STATED THAT THE HYPERTENSIVE EPISODE CAUSED THE EVENT, BUT IT COULD NOT BE DETERMINED WHAT CAUSE THE HYPERTENSIVE EPISODE. FOUR DAYS LATER THE PHYSICIAN ELECTED TO PERFORM AN INTERVENTION, A 5 FRENCH SHEATH WAS PLACED USING ULTRASOUND GUIDANCE ON THE LEFT SIDE. AN 8 FRENCH SHEATH WAS ATTEMPTED TO BE PLACED ON THE RIGHT SIDE BUT WAS UNSUCCESSFUL DUE TO SCAR TISSUE. THE DECISION WAS MADE TO SWITCH THE 8 FRENCH SHEATH TO THE LEFT SIDE. IVUS WAS USED FROM THE LEFT SIDE TO ENSURE THAT THE WIRES WERE IN THE TRUE LUMEN AND THEN O NE OF THE WIRES WAS EXCHANGED FOR A LUNDERQUIST WIRE VIA THE LEFT GROIN. IVUS DETERMINED THE VESSEL DIAMETER AT THE LEFT CAROTID ARTERY MEASURED

  Patient problems: High Blood Pressure/ Hypertension; Vascular Dissection

  MAUDE report 6498145 ↗
• DeathJan 13, 2017Adverse 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 EMERGENT ENDOVASCULAR TREATMENT OF A THORACIC AORTIC TYPE A DISSECTION. THE TYPE A DISSECTION CAUSED NEAR OCCLUSION OF THE CELIAC ARTERY, SUPERIOR MESENTERIC ARTERY, RIGHT RENAL ARTERY, AND LEFT COMMON ILIAC ARTERY. THE PATIENT ENTERED SURGERY WITH END ORGAN COMPROMISE. THE DEVICES WERE DEPLOYED ANTEGRADE THROUGH DIRECT EXPOSURE OF THE DESCENDING THORACIC AORTA. IT WAS REPORTED THAT, DURING THE INDEX PROCEDURE, THE PHYSICIAN IMPLANTED THE FIRST VALIANT STENT GRAFT AND THEN ELECTED TO IMPLANT A SECOND VALIANT STENT GRAFT TO GAIN ADDITIONAL PROXIMAL COVERAGE. THE DISTAL END OF THE SECOND VALIANT STENT GRAFT WAS THEN SEWN TO THE PROXIMAL EDGE OF THE THORACIC AORTA. HOWEVER, AFTER THE AORTIC CLAMP TO THE BODY WAS REMOVED, THE PHYSICIAN OBSERVED THAT THE DESCENDING THORACIC AORTA WAS EXPOSED, THAT THE SECOND VALIANT STENT GRAFT WAS PROTRUDING FROM THE AORTA, AND THAT THERE WAS INSUFFICIENT BLOOD FLOW. THE PHYSICIAN ELECTED TO EXPLANT THE VALIANT STENT GRAFTS, IMPLANTED A DACRON GRAFT, AND COMPLETED THE PROCEDURE. HOWEVER, THE PATIENT DID NOT RECOVER AND EXPIRED ON THE OPERATING TABLE. PER THE PHYSICIAN, THE CAUSE OF THE E

  Patient problems: Death

  MAUDE report 6251913 ↗
• DeathJan 9, 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 EMERGENT ENDOVASCULAR TREATMENT OF A 5.4 CM IN DIAMETER THORACIC AORTIC ANEURYSM. THE PATIENT PRESENTED EMERGENTLY WITH CHEST PAIN TWO DAYS PRE IMPLANT. THE CT REVEALED THAT THERE WAS A TAA AND AAA. PRE-PROCEDURE IT WAS NOTED THAT THE PATIENT¿S BLOOD PRESSURE WAS HYPERVOLEMIC. UP TO 300 SYSTOLIC (UNABLE TO CONTROL THE BLOOD PRESSURE PRIOR TO IMPLANT). THE PATIENT WAS NOT AN OPEN SURGICAL CANDIDATE. PATIENT HAD SEVERELY DISEASED VESSELS. THE PATIENT HAD MODERATELY TO SEVERE CALCIFIED ILIAC ARTERIES, PROXIMAL STENOSIS AND SMALL IN DIAMETER (5MM TO 9MM) ARTERIES. THE PHYSICIAN WAS AWARE THE PATIENT MAY NEED A RETROPERITONEAL CUT DOWN DUE TO THE SMALL IN DIAMETER ACCESS VESSEL. THE PHYSICIAN PERFORMED A CUT DOWN OF THE RIGHT COMMON FEMORAL ARTERY TO GAIN CONTROL OF THE VESSEL WITH VESSEL LOOPS. AN 8FR SHEATH WAS PLACED IN THE CFA, NEXT AN EXCHANGE LENGTH GLIDE WIRE WAS ADVANCED TO THE DESCENDING THORACIC AORTA. A MARKER OMNI FLUSH CATHETER WAS PLACED DISTAL TO THE LEFT SUBCLAVIAN; AN ANGIOGRAM WAS PERFORMED AND THE PROXIMAL AND DISTAL LANDING ZONES WERE IDENTIFIED AND ANOTHER MANUFACTURER¿S WIRE WAS ADVANCED TO THE LEVEL O

  Patient problems: Death

  MAUDE report 6234300 ↗