Valiant Navion™ VNMF4040C103TU (UDI 00763000100711)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000100711), received between May 17, 2019 and Mar 21, 2025 — classified as 6 deaths.

The most frequently reported specific device problem is “Leak/Splash” (4 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• DeathMar 21, 2025Leak/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 THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ADDITIONALLY, AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED THE SAME DAY. APPROX. 1 YEAR AND 2 MONTHS POST INDEX PROCEDURE, A VALIANT NAVION STENT GRAFT WAS IMPLANTED ALONG WITH AN ADDITIONAL ENDURANT LIMB. IT WAS REPORTED ON AN UNKNOWN DATE, THE PATIENT PRESENTED EMERGENTLY EXPERIENCING CHEST AND BACK PAIN. CT IMAGING REVEALED A TYPE IA ENDOLEAK, A TYPE IB ENDOLEAK, AND A TYPE III ENDOLEAK, THOUGH NO RUPTURE WAS OBSERVED. ON (B)(6) 2025, THE PATIENT UNDERWENT RELINING WITH A NON-MDT THORACIC GRAFT. THE RELINING OF THE GRAFTS WAS SUCCESSFUL, BUT MULTIPLE COMPLICATIONS AROSE DURING THE PROCEDURE, INCLUDING A LACERATED BOWEL DUE TO ANESTHESIA-RELATED ISSUES, AND PNEUMONIA. THESE COMPLICATIONS ULTIMATELY LED TO THE PATIENT¿S DEATH 10 DAYS LATER. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS AND GRAFT ISSUES WAS UNKNOWN. AN AUTOPSY REVEALED SIX HOLES IN THE IN THE OUTERMOST VALIANT CAPTIVIA STENT GRAFT WHICH APPEARED TO BE CAUSED BY THE INNER FREE FLOW GRAFT¿S BARE METAL RUBBING THROUGH THE OUTER GRAFT. THE CAUSE OF DEATH WAS DUE TO MULTIPLE COMPLICATIONS FROM THE PROCEDURE IN

  Patient problems: Back pain; Bowel Perforation; Chest Pain; Pneumonia

  MAUDE report 21661774 ↗
• DeathJan 29, 2025Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. THE PATIENT HAD AN EXISTING VALIANT CAPTIVA AND ENDURANT IIS STENT GRAFT SYSTEM IMPLANTED SIX MONTHS EARLIER. IT WAS REPORTED THAT CORELAB REVIEW OF A CT TAKEN ON THE SAME DATE SHOWED AN IA AND IIIA ENDOLEAKS INVOLVING THE VALIANT NAVION. THERE WAS NO FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION OBSERVED. THE MAXIMUM AORTIC DIAMETER WAS 96.8MM. IT WAS NOTED THAT THE VALIANT NAVION WAS FAILING TO SEAL WITH THE OTHER DEVICES. THE SITE COULD NOT CONFIRM WHICH DEVICE THE NAVION HAS LOST SEAL AGAINST. IT IS UNKNOWN IF THERE WERE INTERVENTIONS PERFORMED TO TREAT THE ENDOLEAKS. NO CAUSE WAS PROVIDED. IT WAS REPORTED THE PATIENT EXPIRED THE SAME YEAR. NO CAUSE OF DEATH WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 21263049 ↗
• DeathDec 19, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN 81MM THORACIC AORTIC ANEURYSM ON THE (B)(6) 2020. VALIANT NAVION STENT GRAFT (B)(6) WAS IMPLANTED DISTAL TO LSCA, FOLLOWED CLOSELY BY (B)(6), STENT GRAPH (B)(6) WAS IMPLANTED JUST PROXIMAL TO CELIAC TAKEOFF. IT WAS REPORTED APPROXIMATELY 7 MONTHS POST THE INDEX PROCEDURE, FOLLOW UP CT IMAGING REVEALED A PERSISTENT TYPE II ENDOLEAK ALONG THE PROXIMAL DESCENDING THORACIC AORTA, SPECIFICALLY ALONG THE UNDERSURFACE OF THE AORTIC ARCH AND ANTERIOR TO THE PROXIMAL DESCENDING THORACIC AORTA. THERE WAS A SLIGHT INCREASE IN THE SIZE OF THE ACTIVE CONTRAST FLOW WITHIN THE EXCLUDED ANEURYSM SAC (26 X 16 MM, COMPARED TO 11 X 8 MM PREVIOUSLY) IN THE ARTERIAL PHASE, BUT THE OVERALL SIZE OF THE THORACIC AORTIC ANEURYSM DIAMETERS REMAINED STABLE. THE TWO PROXIMAL VALIANT NAVION DEVICES WERE MOST IMPLICATED BY THE TYPE II ENDOLEAK WHICH APPEARED TO BE SUPPLIED BY AN INTERCOSTAL ARTERY. IT WAS ALSO NOTED THAT (B)(6) HAD SLIGHTLY MIGRATED. APPROXIMATELY 12 MONTHS POST THE INDEX PROCEDURE, IT WAS REPORTED THAT THE PATIENT HAD EXPIRED. PER THE PHYSICIAN THE CAUSE OF THE TYPE II ENDOLEAK AND SUBSEQUENT DE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18356540 ↗
• DeathJul 28, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT 2 AND A HALF YEARS LATER, A CT IMAGES WERE REVIEWED, WHERE A ENDOLEAK TYPE 1B WAS NOTED. IT WAS REPORTED THE TYPE IB ENDOLEAK APPEARED TO TOUCH BOTH OF THE IMPLANTED DEVICES. IT WAS REPORTED AN ADDITIONAL TWO SURGICAL REPAIR PROCEDURES WERE PERFORMED AND THE PATIENT EXPIRED DURING THE SECOND PROCEDURE. IT WAS REPORTED THE CAUSE OF DEATH WAS AN INTRA-OPERATIVE RUPTURED ANEURYSM. IT WAS NOTED THAT DURING THE FIRST INTERVENTION PROCEDURE, AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED ALONG WITH A VALIANT NAVION STENT GRAFT. THE PATIENT REPORTEDLY EXPIRED DURING THE SECOND PROCEDURE WHERE TWO FURTHER STENT GRAFTS HAD BEEN IMPLANTED, A ENDURANT LIMB AND A VALIANT NAVION STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information; Rupture

  MAUDE report 12238586 ↗
• DeathJul 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PATIENT HAD A CHALLENGING LOCATION OF THE ANEURYSM AS IT WAS RIGHT ON THE AORTIC ARCH MAKING IT DIFFICULT TO ADVANCE WIRES AND THE DEVICE INTO THE PLANNED PROXIMAL LANDING ZONE AT THE LCCA. TWO VALIANT NAVION STENT GRAFTS WERE PLACED BUT IT WAS STILL CONSIDERED THAT THEY WEREN'T FAR ENOUGH PROXIMALLY TO OBTAIN A GOOD SEAL. THE PHYSICIAN ATTEMPTED TO SNARE THE DISTAL TIP OF THE WIRE FROM THE GROIN TO CREATE A BETTER ROUTE TO NAVIGATE THE ANATOMY. AFTER SEVERAL ATTEMPTS WITH THE SNARE THEY WERE UNSUCCESSFUL. THE PHYSICIAN THEN PLACED ANOTHER VALIANT NAVION DEVICE PROXIMAL TO THE MOST PROXIMAL DEVICE TO OBTAIN THE SEAL. THERE WERE SEVERAL TIMES WHERE THE INTERVENTIONAL WIRE HAD TO BE REPOSITIONED OVER THE ARCH IN ORDER TO ADVANCE THE DEVICES. IT WAS REPORTED THAT A WEEK POST INDEX PROCEDURE, THE SALES REP CONTACTED THE PHYSICIAN TO ENQUIRE ABOUT THE PATIENT'S CONDITION. THE PHYSICIAN EXPLAINED THAT THE PATIENT SUFFERED AN EMBOLIC STROKE AND DID NOT WAKE FROM THE PROCEDURE AND LATER DIED. AS PER THE PHYSICIAN, THE CA

  Patient problems: Death; Stroke/CVA

  MAUDE report 10217747 ↗
• DeathMay 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT IN THE INFRA-RENAL ABDOMINAL AORTA FOR THE ENDOVASCULAR TREATMENT OF A 75 MM DIAMETER AORTIC ANEURYSM. THE PATIENT HAD PREVIOUSLY BEEN IMPLANTED WITH A TALENT ABDOMINAL STENT GRAFT SYSTEM APPROXIMATELY NINE YEARS EARLIER AND THE NAVION DEVICES WERE IMPLANTED FOR TREATMENT OF THE MIGRATION OF THE TALENT BIFURCATED STENT GRAFT . IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE CANNULATION OF BOTH TALENT GATES WAS CHALLENGING DUE TO THE MIGRATION OF THE DEVICE. IT WAS NOTED THAT NO ENDOLEAK WAS PRESENT ON THE POST IMPLANT ANGIOGRAM, AND GOOD FEMORAL PULSES WERE PRESENT PRIOR TO GROIN CLOSURE. IT WAS REPORTED THAT APPROXIMATELY 30 MINS AFTER THE EVAR, DURING THE GROIN CLOSURE, PULSES WERE LOST AND PRESSURES FLAT-LINED. AN OPEN INTERVENTION WAS PERFORMED IMMEDIATELY TO IDENTIFY THE SOURCE OF BLEEDING. NO EVIDENT ENDOLEAKS WERE DISCOVERED, AND A HEART ATTACK WAS BELIEVED TO HAVE OCCURRED. THE PATIENT EXPIRED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED, HOWEVER IT WAS BELIEVED THAT AN UNIDENTIFIED RUPTURE OF THE AAA SAC WAS THE CAUSE OF THE HEART ATTACK. IT WAS CONFIRMED THAT NO EVIDENCE OF SUCH

  Patient problems: Cardiac Arrest; Death; Rupture

  MAUDE report 8618852 ↗