Valiant Navion™ VNMC4646C175TU (UDI 00763000101183)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000101183), received between Feb 27, 2019 and Jun 17, 2025 — classified as 2 deaths, 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 12, 2021Class IOpen, Classified

   Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.

   Z-1201-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  TWO VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED APPROX. 5 YEARS, 11 MONTHS POST INDEX PROCEDURE, A SECONDARY PROCEDURE WAS PERFORMED. THIS INVOLVED DEBRANCHING OF THE LEFT SUBCLAVIAN AND VERTEBRAL ARTERY WITH TRANSPOSITION. THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 500CC BUT REMAINED STABLE AND DID NOT REQUIRE TRANSFUSION. GOOD FLOW WAS ACHIEVED IN THE SUBCLAVIAN, CAROTID AND LEFT VERTEBRAL ARTERIES FOLLOWING THE TRANSPOSITION. TWO DAYS LATER, A FOLLOW UP PROCEDURE WAS CONDUCTED ADDRESS PROXIMAL DEGENERATION / GRAFT MIGRATION WHICH HAD RESULTED IN A TYPE IA ENDOLEAK. A PROXIMAL EXTENSION WAS PLACED AS PART OF AN ENDOVASCULAR AORTIC REPAIR. ADDITIONAL DISTAL COMPONENTS WERE PLACED TO TREAT EXPANDING PARA VISCERAL AND DISTAL DESCENDING OF TAA, WHICH DEVELOPED ABOVE THE PREVIOUSLY PLACED ABDOMINAL FENESTRATED GRAFT. THE SUPERFICIAL FEMORAL ARTERY (SFA) WAS NOTED TO BE DIFFUSELY DISEASED WITH TWO REGIONS OF SEVERE STENOSIS. DURING THIS PROCEDURE, THREE NON-MEDTRONIC GRAFTS WERE SUCCESSFULLY IMPLANTED IN THE THORACIC AORTA, ACHIEVING EXCELLENT FLOW THROUGH THE GRAFTS AND EFFECTIVE COVERAGE OF THE DISEASED AORTA. THE PROXI

  Patient problems: Aneurysm expansion; Insufficient Information

  MAUDE report 22227166 ↗
• MalfunctionAug 9, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. IT WAS REPORTED THAT ON FOLLOW UP CT IDENTIFIED FROM 2 YEARS AND 5 MONTHS POST INDEX PROCEDURE A TYPE II ENDOLEAK WHICH WAS CONFIRMED AS NOT RELATED TO THE DEVICE. CORELAB REVIEW OF CT IMAGING FROM THE SAME DATE IDENTIFIED A PRESENCE OF AN UNDETERMINED ENDOLEAK INVOLVING THE VALIANT NAVION. THERE WAS NO STENT RING ENLARGEMENT OR STENT RING MIGRATION OBSERVED. THE MAXIMUM AORTIC DIAMETER WAS 80.2MM. AORTIC ENLARGEMENT OF +5MM WAS OBSERVED WHEN COMPARED TO PREVIOUS IMAGING FROM APPROXIMATELY 1.5 YEAR POST INDEX . THE IMAGES WERE NOTED AS NOT EXAMINABLE FOR FRACTURES DUE TO ARTIFACT. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE M ONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pain

  MAUDE report 17485934 ↗
• DeathJul 18, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  AN ENDURANT IIS BIFURCATE STENT GRAFT SYSTEM AND FOUR VALIANT NAVION (B)(6) STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A ANEURYSM ON (B)(6) 2019.  A VALIANT (B)(6) STENT GRAFT WAS ALSO IMPLANTED 3 MONTHS LATER AND ANOTHER VALIANT GRAFT (B)(6) SUBSEQUENTLY IMPLANTED APPROXIMATELY 8 MONTHS POST THE INDEX PROCEDURE.  IT WAS REPORTED APPROXIMATELY 9 MONTHS POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED A TYPE IIIA ENDOLEAK WAS NOTED AT THE ABDOMINAL AORTIC STENT WHICH EXTENDS SUPERIORLY INTO THE DISTAL THORACIC AORTA. 9.5X7.8CM.  CT AT 12 MONTHS SHOWED THERE WAS A PATENT ENDOVASCULAR STENT WHICH EXTENDS FROM THE DISTAL AORTIC ARCH INTO THE INFRARENAL ABDOMINAL AORTA, THERE IS A PERSISTENT LARGE TYPE III EL OF THE ABDOMINAL AORTIC STENT WHICH EXTENDS SUPERIORLY INTO THE DISTAL THORACIC AORTA, STABLE IN SIZE COMPARED TO PREVIOUS IMAGES. 8.4X7.0CM.  INTERVENTION WAS THEN PERFORMED WHERE EMBOLIZATION WITH COILING WAS PERFORMED. A CT POST INTERVENTION APPROXIMATELY 16 MONTHS POST THE INDEX PROCEDURE SHOWED A NEW TYPE I ENDOLEAK ORIGINATING AT THE LEVEL OF THE PROXIMAL THORACIC ENDOGRAFT. THE PREVIOUS TYPE III ENDOLEAK WENT FROM 8.5CM TO 9.6CM. EMBOLIZATION WAS PERFORMED

  Patient problems: Cardiac Arrest

  MAUDE report 17340456 ↗
• MalfunctionJun 29, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT  A CT WAS PERFORMED. CORELAB HAVE REVIEWED THIS IMAGING AND IDENTIFIED A TYPE IA ENDOLEAK. THE MAXIMUM AORTIC DIAMETER WAS 82.6MM. A FRACTURE OR STENT RING MIGRATION WERE NOT EXAMINABLE DUE TO CALCIUM. NO STENT RING ENLARGEMENT NOTED.  NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17223684 ↗
• DeathFeb 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA . IT WAS REPORTED CT IMAGING TAKEN UNDER 3 YEARS LATER, A TYPE IA ENDOLEAK WAS IDENTIFIED ON THE STENT GRAFT WITH SN (B)(4). THE MAXIMUM AORTIC DIAMETER WAS 71.7MM. NO STENT RING ENLARGEMENT OR MIGRATION WERE NOTED.  NE FOR FRACTURES DUE TO DEVICE OVERLAPS.  THE PATIENT DIED UNDER A MONTH LATER DUE TO AN UNKNOWN CAUSE. THERE IS NO DEATH CERTIFICATE AVAILABLE. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 16395081 ↗
• InjuryNov 15, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT AND A VALIANT CAPTIVIA STENT GRAFT WERE IMPLANTED DURING AN ENDOVASCULAR TREATMENT. 2 ENDURANT II STENT GRAFTS (ETBF3216C145E AND ETLW1616C93E) WERE IMPLANTED APPROXIMATELY 5 YEARS PREVIOUS. 2 TALENT THORACIC STENT GRAFTS (TW4238C111CP & TF4242C198CP) WERE IMPLANTED APPROXIMATELY 8 YEARS PREVIOUS. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING FROM (B)(6) 2021 FOR THE NAVION GRAFT IDENTIFIED A NEW TYPE IB ENDOLEAK. NO STENT RING ENLARGEMENT WAS OBSERVED. THE IMAGING WAS NOTED AS NE FOR FRACTURE AND STENT RING MIGRATION DUE SCAN QUALITY AND OVERLAPS. A TYPE IA ENDOLEAK ON A PROXIMAL NON-NAVION GRAFT WAS IDENTIFIED. AN UNKNOWN INTERVENTION WAS COMPLETED. THE CAUSE OF THE ENDOLEAKS ARE UNDETERMINED. IT WAS NOTED TYPE IB ENDOLEAK DUE TO COMPLETE LOSS OF SEAL ON DISTAL END OF DEVICE (NO CONTRAST GOING INTO THE ANEURYSM SAC, BUT IF THERE¿S NO SEAL AT ALL, IT¿S THE SAME AS A TYPE I (A OR B DEPENDING ON THE END). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15796104 ↗
• MalfunctionNov 7, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT S WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT THE PRESENCE OF A TYPE 1 A ENDOLEAK WITH AORTIC ENLARGEMENT OF +6.2MM WAS OBSERVED ON IMAGING OVER 2 YEARS LATER . IT WAS ALSO NOTED THAT THERE WAS A PRESENCE OF INTRALUMINAL THROMBUS AS WELL AS A COMPLETE LOSS OF SEAL AT THE DISTAL END OF THE DEVICE. NO FRACTURES OR STENT RING ENLARGEMENT WERE IDENTIFIED. NO CAUSE OF THE EVENT WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12758467 ↗
• InjuryFeb 27, 2019Malposition of Device; Activation, Positioning or Separation Problem; Malposition of Device; Activation, Positioning or Separation Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, WHILE DEPLOYING A SECOND DEVICE, A VALIANT NAVION, IN THE DESCENDING THORACIC AORTA THE MEAN ARTERIAL PRESSURE (MAP) WAS ALLOWED TO INCREASE FROM 60 TO 92 BY THE ANESTHETIST FOR THE PATIENT. DUE TO THIS CHANGE, THE PHYSICIAN NOTED THE DEVICE STARTING TO BE PUSHED BACK WHEN APPROXIMATELY 2/3RD OF THE STENT GRAFT WAS DEPLOYED. THIS LED TO THE DEVICE ALMOST INFOLDING ON ITSELF AND THE PROXIMAL END WAS 80-100MM BELOW TARGET. IT WAS REQUESTED THAT THE MAP BE LOWERED AND THE PHYSICIAN WAS ABLE TO PUSH UP THE UN-DEPLOYED DISTAL END OF THE DEVICE ABOVE THE TARGET AND FINISH DEPLOYMENT. THE DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED AND ANOTHER NAVION STENT GRAFT WAS DEPLOYED THROUGH THE "ACCORDION" PART OF THE PREVIOUS NAVION DEVICE TO BRIDGE THE DEVICES TOGETHER. THIS WAS SUCCESSFUL AND THE CASE WAS COMPLETED WITH THE PATIENT DOING WELL. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO THE COMBINATION OF THE HIGH MAP AND THE USE OF THE LARGEST THORACIC DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WER

  Patient problems: Injury

  MAUDE report 8373457 ↗