Valiant Navion™ VNMF4343C103TU (UDI 00763000100759)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000100759), received between Dec 12, 2019 and Jan 23, 2026 — classified as 3 deaths, 3 injuries, 1 malfunction.

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Leak/Splash

  IT WAS REPORTED BY THE PATIENT, THROUGH PATIENT SERVICES, THAT A LEAK DEVELOPED IN A VALIANT NAVION STENT GRAFT IMPLANTED. THE LEAK OCCURRED APPROXIMATELY 3 YEARS POST IMPLANT AND WAS NOT COMMUNICATED TO THE PATIENT BY THE PHYSICIAN. THE PATIENT REPORTED DEVELOPING PARTIAL VOCAL CORD PARALYSIS AS A RESULT OF THE LEAK.

  Patient problems: Paralysis

  MAUDE report 24158963 ↗
• DeathFeb 13, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A DISSECTION. IT WAS CONFIRMED THE STENT GRAFT V08146979 WAS IMPLANTED PROXIMALLY. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PATIENT WAS FOUND TO HAVE A INTIMAL DEFECT AT THE PROXIMAL LANDING SITE CAUSING A TYPE A DISSECTION AND IA ENDOLEAK.  A CT WAS PERFORMED APPROXIMATLEY 8 MONTHS POST THE INDEX PROCEDURE, WHICH SHOWED THE TYPE IA ENDOLEAK. ANOTHER CT  ALSO SHOWED THE TYPE IA ENDOLEAK AND AORTIC ENLARGEMENT AT THE PROXIMAL TEVAR SITE.  INTERVENTION WAS PERFORMED , A NON MDT STENT GRAFT WAS PLACED IN THE AORTIC ARCH. AT ANOTHER INTERVENTION DATE A LSCA BYPASS WAS PERFORMED AND A NON MDT AORTIC ROOT GRAFT WAS PLACED DURING A HEMI ARCH REPLACEMENT.  CORELAB REVIEWED CT IMAGING DATED 10TH OF NOV 2020; THE TYPE IA ENDOLEAK WAS NOTED ON THE STENT GRAFT V08146979. NE FOR FRACTURES ON THIS STENT GRAFT DUE TO DEVICE OVERLAPS. NO FRACTURES WERE NOTED OTHERWISE, NO STENT RING ENLARGEMENT OR STENT RING MIGRATION. THE MAXIMUM AORTIC DIAMETER WAS 70.8MM. IT WAS REPORTED THE PATIENT DIED ON AN UNKNOWN DATE. THE CAUSE OF DEATH IS UNKNOWN.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIR

  Patient problems: Cardiac Arrest; Insufficient Information; Liver Failure; Pericardial Effusion; Shock; Vascular Dissection

  MAUDE report 16361006 ↗
• DeathNov 17, 2022Leak/Splash; Leak/Splash

  VALIANT NAVIONS STENT GRAFT WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM.  IT WAS REPORTED THAT ON CT PERFORMED APPROXIMATELY 9 MONTHS POST THE INDEX PROCEDURE AN AORTIC STENT GRAFT WAS IDENTIFIED EXTENDING FROM THE AORTIC ARCH TO THE DISTAL DESCENDING THORACIC AORTA. CONTRAST WAS IDENTIFIED IN THE ANEURYSMAL SAC OUTSIDE OF THE STENT GRAFT, CONSISTENT WITH AN ENDOLEAK. THE SIZE OF THE ANEURYSMAL SAC OF THE DESCENDING THORACIC AORTA WAS RELATIVELY STABLE, MEASURING 84MM IN MAXIMUM DIAMETER. THE ENDOLEAK IS NEW COMPARED WITH PRIOR EXAM.  THERE WAS NO  CAUSE OF ENDOLEAK PROVIDED.  THE PATIENT HAS DIED ON AN UNKNOWN DATE DUE TO AN UNKNOWN CAUSE. NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AND THE PATIENT HAS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 15812835 ↗
• InjuryJun 29, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 89 MM ABDOMINAL AORTIC ANEURYSM. APPROXIMATELY 4 MONTHS LATER, A CT WAS PERFORMED WHERE A TYPE IA ENDOLEAK WAS OBSERVED. DEBRANCHING WAS PERFORMED TO RESOLVE THE E NDOLEAK. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION, SO THE DEVICE FAILED TO MAINTAIN SEAL. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12084359 ↗
• MalfunctionJun 19, 2020Difficult or Delayed Positioning; Activation, Positioning or Separation Problem; Difficult or Delayed Positioning; Activation, Positioning or Separation Problem

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60MM * 100MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT ON JUST UNDER FIVE YEARS LATER, THE PATIENT PRESENTED WITH BACK PAIN AND A TYPE IA AND IB ENDOLEAKS WAS OBSERVED ON CT. INTERVENTION WAS PERFORMED THE NEXT DAY, THE PHYSICIAN IMPLANTED A VNMF4343C103E, IT WAS REPORTED THERE WAS GREAT DIFFICULTY POSITIONING THIS DEVICE DUE TO SEVERE TORTUOSITY. DUE TO THE SEVERE ANGULATION THE TIP CAPTURE MECHANISM WOULD NOT RELEASE SO THE PHYSICIAN PERFORMED THE NON RELEASE TIP CAPTURE MECHANISM IN ORDER TO DEPLOY THE BARE SPRING. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND DUE TO DISEASE PROGRESSION OF THE DISTAL AORTA. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10173675 ↗
• DeathApr 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 89MM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT POST-OPERATIVELY A CT PERFORMED 2 YEARS AND 11 MONTHS LATER IDENTIFIED A TYPE IA ENDOLEAK WAS PRESENT. IT WAS REPORTED THAT THE ANEURYSM MEASURED 7.5 CM X 8.9 CM. INTERVENTION WAS PERFORMED JUST UNDER A MONTH LATER, A ENDURANT AORTIC CUFF ETCF3636C49E WAS IMPLANTED ALONG WITH THE IMPLANTATION OF ENDOANCHORS. A 6X22 NON-MDT( ICAST) WAS ALSO PLACED IN THE LEFT RENAL. DESPITE THIS THE TYPE IA ENDOLEAK WAS STILL PRESENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY AND NOTED THE AORTIC NECK DIAMETER HAD ENLARGED. IT WAS REPORTED THE PATIENT PRESENTED TO THE ER WITH A RUPTURED ANEURYSM APPROXIMATELY FOUR WEEKS POST THE RE-INTERVENTION. A CHIMNEY WAS PLACED IN THE LEFT RENAL ARTERY AND A ENDURANT AORTIC CUFF ETCF3636C49E WAS IMPLANTED UP TO THE RIGHT RENAL AND SMA. A CHIMNEY WAS THEN PLACED INTO THE SMA AND COVERED THE RIGHT RENAL ARTERY, SMA, AND CELIAC ARTERY WITH A VALIANT NAVION VNMF4343C103E STENT GRAFT AND THEN PLACED ANOTHER VALIANT NAVION VNMF4040C103E MORE PROXIMALLY. A FINAL ANGIOGRAM SHOWED THE IA ENDOLEAK HAD RESOLVED AN

  Patient problems: Cardiac Arrest; Death

  MAUDE report 9942371 ↗
• InjuryDec 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT AS A PROXIMAL EXTENSION, FOR THE ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM. THE MID TO DISTAL DESCENDING THORACIC AORTA MEASURING 80MM AT ITS GREATEST DIMENSION. THE PATIENT WAS ALSO TREATED FOR A INFRARENAL AND EXTERNAL ANEURYSM MEASURING 60MM AT ITS GREATEST DIMENSION. THE CASE WAS A PHYSICIAN SPONSORED IDE. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DEVICE WAS IMPLANTED SUCCESSFULLY. HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, IT BECAME CAUGHT ON A SUPRARENAL STENT AND WAS KINKED. THIS WAS RESOLVED BY BALLOONING THE STENT GRAFT AND RELINING IT WITH ANOTHER NAVION DEVICE. THE INVESTIGATOR ASSESSED THE CAUSE OF THE EVENT WAS POSSIBLE DUE TO BE AN OPERATOR ERROR AND NOT A DEVICE MALFUNCTION. IT WAS REPORTED THAT AN ADDITIONAL VALIANT NAVION STENT GRAFT AND TWO ENDURANT II STENT GRAFT LIMBS WERE ALSO IMPLANTED DURING THE PROCEDURE. THREE ADVERSE EVENTS HAVE BEEN FURTHER REPORTED: INTRA-ABDOMINAL HEMORRHAGE WHICH IS CONFIRMED AS RESOLVED WITH SEQUELAE, ACUTE KIDNEY INJURY WHICH IS REPORTED AS ONGOING AND LEFT KIDNEY INFARCT WHICH IS ALSO ONGOING. PER THE INVESTIGATOR THE CAUSE OF THESE ADVERSE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Renal Failure

  MAUDE report 9456844 ↗