Valiant Navion™ VNMC3434C90TU (UDI 00763000101015)Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 00763000101015), received between Jul 23, 2020 and Apr 23, 2024 — classified as 4 deaths, 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (12 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 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• DeathApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT ((B)(6)) AND AN ENDURANT IIS STENT GRAFT SYSTEM WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL ANEURYSM AND AORTIC DISSECTION. THE PATIENT HAD 2 EXISTING VALAINT CAPTIVIA THORACIC STENT GRAFTS IMPLANTED APPROXIMATELY 3 YEARS PREVIOUS. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE NAVION IMPLANT PROCEDURE, FOLLOW UP CT SHOWED AN AORTIC DISSECTION AND AORTIC RUPTURE. IT WAS REPORTED THE PATIENT EXPIRED 2 DAYS POST THE CT. PER THE PHYSICIAN THE CAUSE OF THE AORTIC DISSECTION AND RUPTURE IS UNDETERMINED. THE CAUSE OF DEATH WAS DUE TO THE AORTIC DISSECTION.

  Patient problems: Rupture; Vascular Dissection

  MAUDE report 19162007 ↗
• MalfunctionSep 25, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA .  IT WAS REPORTED THAT CT IMAGING WAS PERFORMED . CORELAB HAVE REVIEWED THIS IMAGING AND IDENTIFIED A TYPE IA ENDOLEAK. NO FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS NOTED. THE MAXIMUM AORTIC DIAMETER WAS 48.9MM . NO AORTIC ENLARGEMENT WAS 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 17806178 ↗
• InjuryAug 17, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED ON THE (B)(6) 2020 DURING REINTERVENTION FOR MULTIPLE ENDOLEAKS IN A NON-MEDTRONIC GRAFT WHICH WAS IMPLANTED IN 2004. TWO ENDURANT LIMBS EXTENSIONS WERE IMPLANTED FOR AN UNKNOWN REASON ON THE IT WAS REPORTED ON (B)(6) 2022 TWO ENDURANT LIMB EXTENSIONS WERE IMPLANTED TO TREAT A PERSISTENT ENDOLEAK WITHIN THE DESCENDING THORACIC AORTA AND VISCERAL SEGMENT WITH INCREASE IN DESCENDING AORTA AS WELL AS INFRARENAL AORTA AND TYPE III ENDOLEAK OF THE VISCERAL SEGMENT AND ENDOLEAK OF THE DISTAL LEFT ILIAC LIMB. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING FROM (B)(6) 2022. CORELAB HAVE REVIEWED THIS IMAGING AND IDENTIFIED A NON NAVION IB ENDOLEAK FROM THE LEFT ILIAC ARTERY AND LEFT THORACOABDOMINAL BRANCH PERFUSING ANEURYSM SAC. NO ENDOLEAK, FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS NOTED ON THE NAVION STENT GRAFT. THE MAXIMUM AORTIC DIAMETER WAS 41.5MM. THE CAUSE OF THE ENDOLEAK WAS NOT REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17564523 ↗
• InjuryAug 11, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE ANEURYSM. IT WAS REPORTED THAT CORELAB REVIEW OF CT IMAGING FROM APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE IDENTIFIED A TYPE IA ENDOLEAK AND A MAXIMUM AORTIC DIAMETER OF 69.6MM. THE ENDOLEAK WAS ALSO OBSERVED ON IMAGING 6 MONTHS LATER, APPROXIMATELY 25 MONTHS POST INDEX PROCEDURE AND THE MAXIMUM AORTIC DIAMETER WAS NOTED TO MEASURE 70.3MM. THERE WAS NO STENT RING ENLARGEMENT , STENT RING MIGRATION OR AORTIC ENLARGEMENT OBSERVED. THE IMAGES WERE NOTED AS NOT EXAMINABLE FOR FRACTURE DUE TO SCAN QUALITY. IT WAS NOTED THAT THE IMAGING FROM 25 MONTHS WAS NON-CONTRAST, HOWEVER COMPLETE LOSS OF SEAL AT THE PROXIMAL END WAS OBSERVED.  NO CAUSE WAS REPORTED. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 17508505 ↗
• MalfunctionJun 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN LENGTH DISSECTION. IT WAS REPORTED THAT A CT WAS TAKEN. CORELAB HAVE REVIEWED THIS IMAGING AND IDENTIFIED A NEW TYPE IA ENDOLEAK ON THE STENT GRAFT WITH SN (B)(6). STENT RING ENLARGEMENT OF +2.1MM WAS NOTED ON THE STENT GRAFT (B)(6). NO FRACTURE OR STENT RING MIGRATION WERE NOTED. THE MAXIMUM AORTIC DIAMETER WAS 47.9MM. N/A FOR AORTIC ENLARGEMENT. 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 17223526 ↗
• InjuryApr 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN LENGTH DISSECTION. TWO ENDURANT LIMBS WERE ALSO IMPLANTED ON THE SAME DATE. IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT REVEALED THE PATIENT WAS AT RISK OF ENLARGEMENT IN THE THORACIC AORTA. ENLARGEMENT WAS A RISK PRIOR TO RECOMMENDING TEVAR DUE TO UNCONTROLLED HTN AND IT WAS REPORTED NO ENLARGEMENT HAS BEEN OBSERVED SINCE INTERVENTION. 10 MONTHS LATER, THE PATIENT WAS BROUGHT TO THE ED FROM AN OUTSIDE FACILITY WITH A HEADACHE AND ACUTE CHEST PAIN. A DIAGNOSIS OF A TYPE A AORTIC DISSECTION (RETROGRADE SECONDARY TO AORTIC STENT). WAS GIVEN. PER THE CTA CHEST REPORT IT WAS A TYPE A AORTIC DISSECTION WITH PROXIMAL EXTENSION INTO THE AORTIC ROOT RESULTING IN SMALL VOLUME HEMOPERICARDIUM. IT WAS ALSO NOTED THERE WAS UNCHANGED DESCENDING THORACIC AORTIC ENDOGRAFT WITH CHRONIC TYPE B AORTIC DISSECTION EXTENDING INTO THE ABDOMINAL AORTA. EMERGENT SURGICAL CONSULTATION WAS REQUESTED. NO ADDITIONAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Headache; Pain; Vascular Dissection

  MAUDE report 16814227 ↗
• DeathFeb 20, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING APPROXIMATELY 15 MONTHS POST THE INDEX PROCEDURE IDENTIFIED A NEW TYPE IB ENDOLEAK. NO STENT FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED. THE MAX AORTIC DIAMETER WAS NOTED AS 42.3MM. THE IMAGING WAS NOTED AS NA FOR AORTIC ENLARGEMENT. THE CAUSE OF THE TYPE IB ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 16404581 ↗
• InjuryJan 26, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION THORACIC STENT GRAFTS WERE IMPLANTED FOR THE TREATMENT OF  AN UNKNOWN SIZE ANEURYSM ON (B)(6) 2020. IT WAS REPORTED THAT A CT PERFORMED APPROXIMATELY 26 MONTHS POST INDEX PROCEDURE NOTED AN INCREASE IN AORTIC DIMENSION IN THE DISTAL ARCH AND DESCENDING THORACIC AORTA, WHICH NOW MEASURES 47MM. CORELAB REVIEW OF CT IMAGING FROM THE SAME DATE IDENTIFIED A TYPE IA ENDOLEAK INVOLVING VNMC3434C90TU (B)(4). THERE WAS NO STENT FRACTURE, STENT RING ENLARGEMENT OR STENT RING DETACHMENT OBSERVED. NO CAUSE OF ENDOLEAK PROVIDED. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 16245787 ↗
• InjuryNov 9, 2022Adverse 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 UNKNOWN LENGTH DISSECTION.  IT WAS REPORTED A CT PERFORMED UNDER 2 YEARS LATER, IDENTIFIED THE PATIENTS PROXIMAL DESCENDING AORTA ENLARGED FROM 3.4 TO 4. 3 MONTHS LATER, SURGICAL REPAIR WAS PERFORMED. THE PATIENT UNDERWENT A LEFT THORACOTOMY, REPLACEMENT OF DESCENDING THORACIC AORTA WITH 30 MM GRAFT , EVACUATION OF CHRONIC HEMATOMA FROM DESCENDING THORACIC AORTIC ANEURYSM AND FENESTRATION OF CHRONIC AORTIC DISSECTION FLAP IN DISTAL DESCENDING THORACIC AORTA. THE PATIENT WAS STABLE POST PROCEDURE.  PER THE PHYSICIAN THE CAUSE OF THE EVENT IS THE PATIENTS MEDICAL HX OF MARFAN'S SYNDROME.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; Hematoma

  MAUDE report 15758333 ↗
• DeathOct 26, 2022Leak/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 FOR THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM.   IT WAS REPORTED THAT CORELAB REVIEW OF  CT'S CARRIED OUT 3 DAYS POST-IMPLANT IDENTIFIED A TYPE IB ENDOLEAK ON DEVICE VNMC3737C90TU  (SN (B)(4).  THERE WAS NO FRACTURES, STENT RING ENLARGEMENT OR  STENT RING MIGRATION OBSERVED. IT WAS NOTED THAT THE DEVICE IMPLANT ORDER WAS UNABLE TO BE CONFIRMED BY THE SITE.   IT WAS REPORTED THE PATIENT DIED ON A AN UNKNOWN APPROXIMATELY 7 MONTHS POST THE INDEX PROCEDURE LIKELY FROM ANEURYSM RUPTURE. IT WAS STATED  THAT THE DEVICE CONSTRUCTION WAS ATYPICAL WITH PARALLEL GRAFTS (SNORKELS, CHIMNEYS, ETC) AND  SHOULD NOT BE CONSIDERED DEVICE FAILURE.   NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AND THE PATIENT EXPIRED

  Patient problems: Insufficient Information

  MAUDE report 15672066 ↗
• InjuryOct 18, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 55MM TAA ON THE (B)(6) 2019.  IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP ON (B)(6) 2021, AFTER REVIEW OF THE PATIENT'S CT SCAN, THE PATIENT WAS COMPLAINING OF PAIN AND IT MAY BE THAT THE PATIENT'S PAIN IS COMING FROM EXPANSION OF THE TRUE LUMEN DUE TO STENT PLACEMENT. DESPITE SOME RETROGRADE FILLING INTO THE FALSE LUMEN, THE RESIDUAL ANEURYSM SAC IS STABLE. THERE IS A SMALL, STABLE PSEUDOANEURYSM.  1 YEAR LATER, IT WAS NOTED ON IMAGING THAT THERE IS THERE IS RETROGRADE FILLING INTO THE FALSE LUMEN- WHICH IS WORSE/ BRIGHTER THAN ON PRIOR IMAGING. THIS FILLING HAS LED TO A SMALL AMOUNT OF EXPANSION OF THE FALSE LUMEN FROM 5.3CM TO 5.6CM OVER A YEAR. THERE IS ALSO A NEW OUTPOUCHING WITHIN THE FALSE LUMEN AT THE DISTAL ASPECT OF THE STENT. 2 FURTHER DAYS LATER, THE PATIENT WAS NOTED TO HAVE ALWAYS HAD PAIN BUT SAYS ITS WORSE THAN A YEAR BEFORE. THE PAIN GOT WORSE GRADUALLY AND NOW THE PATIENT  DOES HAVE EPISODES OF SEVERE PAIN. THE PATIENT COMPLAINS OF PAIN AT THE ANATOMICAL SITE OF THIS NEW OUTPOUCHING. THE PAIN HAS SIGNIFICANTLY AFFECTED THE PATIENTS  QUALITY OF LIFE AND MENTAL HEALTH. THE RESI

  Patient problems: Pain; Paresis

  MAUDE report 15625038 ↗
• MalfunctionOct 6, 2022Material Deformation; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THE CORE LAB REVIEWED CT IMAGES FROM THE (B)(6) 2020 AND (B)(6) 2021 AND NOTED AN OBSERVATION OF A STENT RING ENLARGEMENT. PER THE PHYSICIAN THE CAUSE OF THE STENT RING ENLARGEMENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15555734 ↗
• MalfunctionJun 16, 2022Leak/Splash; Inadequacy of Device Shape and/or Size; Leak/Splash; Inadequacy of Device Shape and/or Size

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF AN ABDOMINAL AORTIC ULCER. IT WAS REPORTED THAT APPROXIMATELY 15 MONTHS POST INDEX PROCEDURE THE PATIENT RETURNED FOR A FOLLOW-UP CT. CORELAB REVIEW OF CT IMAGES IDENTIFIED A TYPE IB ENDOLEAK ASSOCIATED WITH THE STENT GRAFT WITH SN (B)(4). NO FRACTURE OR STENT RING ENLARGEMENT WERE OBSERVED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO OVERSIZED DEVICE.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm

  MAUDE report 14712448 ↗
• MalfunctionJan 27, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM.  IT WAS REPORTED APPROXIMATELY 1 YEAR POST THEN INDEX PROCEDURE FOLLOW UP CT DEMONSTRATED AN UNKNOWN ENDOLEAK. THE CORE LAB REVIEWED THE IMAGES AND ALSO IDENTIFIED THE UNKNOWN ENDOLEAK. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13364851 ↗
• MalfunctionOct 1, 2021Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR AN ENDOVASCULAR TREATMENT. APPROXIMATELY 2 YEARS POST IMPLANT IT WAS REPORTED THE (B)(6)LAB OBSERVED A TYPE IIIA ENDOLEAK FROM CTS TAKEN ON (B)(6) 2019 IT WAS REPORTED THE TYPE IIIA ENDOLEAK WAS LOCATED BETWEEN THE 2 DISTAL DEVICES, THE STENT GRAFTS WITH SERIAL NUMBERS (B)(4) AND (B)(4). NO CAUSE OF THE EVENT WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12561293 ↗
• InjuryMar 31, 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 WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC DISSECTION. TWO DAYS POST PROCEDURE, THE PATIENT EXPERIENCED STENT INDUCED ENTRY TEAR. THE EVENT WAS ASSESSED BY THE SITE AS POSSIBLY RELATED TO THE DEVICE AND PROCEDURE. THE SPONSOR HAS ASSESSED THE EVENT AS RELATED TO BOTH THE DEVICE AND THE PROCEDURE. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm; Vascular Dissection

  MAUDE report 11596415 ↗
• DeathJul 23, 2020Leak/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 AORTIC INTRAMURAL HEMATOMA (IMH). IT WAS REPORTED THAT APPROXIMATELY TEN MONTHS POST INDEX PROCEDURE ON ROUTINE FOLLOW-UP, A CT PERFORMED SHOWED THAT GRAFT SEPARATION HAD OCCURRED BETWEEN THE VNMC3434C90TU AND VNMF3434C97TU COMPONENTS. APPROXIMATELY 2 WEEKS LATER THE PHYSICIAN PLACED ANOTHER VALIANT NAVION STENT GRAFT TO RECONNECT THE GRAFTS. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CANNOT BE DETERMINED. THE PATIENT WAS DISCHARGED TWO DAYS POST INTERVENTION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Cardiac Arrest; Injury; Insufficient Information; Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 10313329 ↗