Valiant Navion™ VNMF3737C174TU (UDI 00763000100681)Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00763000100681), received between Oct 30, 2019 and Jul 16, 2024 — classified as 2 deaths, 7 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2024Leak/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 DURING ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. VALIANT STENT GRAFT (VNMF3737C174TU) WAS IMPLANTED IN ZONES 1 AND 2, WHILE (VNMC3731C207TU) WAS IMPLANTED IN ZONES 4 AND 5. NO DEVICE DEFICIENCIES WERE OBSERVED. IT WAS REPORTED 46 DAYS POST INDEX PROCEDURE, THAT FOLLOW UP CT SCAN WITH AND WITHOUT CONTRAST REVEALED A TYPE IB ENDOLEAK. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Hematoma; No Clinical Signs, Symptoms or Conditions; Ulcer

  MAUDE report 19750057 ↗
• InjuryMar 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT SHOWED ASCENDING AORTIC ULCER OF THE ANTERIOR PROXIMAL ARCH/ ASCENDING AORTA SECONDARY TO UNCOVERED PROXIMAL STENT. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION. APPROXIMATELY 3 WEEKS POST ADMISSION THE ULCER RESOLVED WITHOUT SEQUELAE. THE SITE ASSESSED THE AORTIC ULCER AS HAVING A PROBABLE RELATIONSHIP TO THE STUDY DEVICE AND PROCEDURE AND NOT RELATED TO THE DISSECTION. THE MEDICAL MONITOR ASSESSED THE AORTIC ULCER AS RELATED TO THE DEVICE AND DISSECTION AND NOT RELATED TO THE INDEX PROCEDURE. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; Ulcer

  MAUDE report 18957945 ↗
• DeathJan 24, 2023Leak/Splash; Malposition of Device; Leak/Splash; Malposition of Device

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION. IT WAS REPORTED APPROXIMATELY 17 MONTHS POST THE INDEX PROCEDURE AN UNDETERMINED ENDOLEAK WAS OBSERVED. INTERVENTION WAS COMPLETED WHERE A VALIANT NAVION STENT GRAFT WAS IMPLANTED. FOLLOW UP CTS 4 DAYS POST THE INTERVENTION, AND AT 1 AND 2 MONTHS POST THE INTERVENTION ALL NOTED THE UNDETERMINED ENDOLEAK. IT WAS REPORTED THE PATIENT EXPIRED ON AN UNKNOWN DATE. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK AND DEATH IS UNDETERMINED.

  Patient problems: Insufficient Information

  MAUDE report 16233600 ↗
• InjuryJan 24, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 14 MONTHS POST THE INDEX PROCEDURE, FOLLOW UP CT IDENTIFIED A TYPE IB ENDOLEAK AND ANEURYSM ENLARGEMENT. ON (B)(6) 2021 INTERVENTION WAS COMPLETED - TAAA THREE-VESSEL SNORKELING WAS COMPLETED WITH A NON MDT STENT TO THE LEFT RENAL, NON MDT FENESTRATED ENDOVASCULAR GRAFT 8.5X8X199, NON MDT 6MMX5CMX120 GRAFT AT THE LEFT RENAL, AND A NON MDT GRAFT 7.7X28X82MM IMPLANTED. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 16232035 ↗
• MalfunctionNov 17, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 58MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THAT ON A FOLLOW UP CT AN ENDOLEAK WAS IDENTIFIED ALONG THE INFERIOR MARGIN OF THE ENDOGRAFT WITH INCREASED  SIZE OF THE ANEURYSM SAC INVOLVING THE DISTAL THORACIC AORTA AND PROXIMAL ABDOMINAL AORTA. NO CAUSE OF THE ENDOLEAK WAS PROVIDED. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 15812869 ↗
• DeathMar 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION WAS IMPLANTED DURING A ENDOVASCULAR TREATMENT OF A DISSECTION. IT WAS REPORTED THAT ONE DAY POST PROCEDURE THE PATIENTS FEMORAL ACCESS CLOSURE DEVICE DISLODGED WHICH LED TO BLEEDING FROM THE COMMON FEMORAL ARTERY THE PATIENT DIED ON THE SAME DATE FROM THIS BLEEDING EVENT. PER PHYSICIAN, THE CAUSE OF THE DEATH WAS DUE TO BLEEDING FROM THE FEMORAL ACCESS SITE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT EXPIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13731681 ↗
• InjuryFeb 2, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 57MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP. A CT CARRIED OUT SHOWED THE PRESENCEOF A TYPE IIIB ENDOLEAK FROM THE MIDDLE OF THE STENT GRAFT. THE PATIENT IS ASYMPTOMATIC. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DUE TO A GRAFT DEFECT.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 13423465 ↗
• MalfunctionJan 27, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A 81MM THORACIC AORTIC ANERUSYM.  IT WAS REPORTED ON THE ONE MONTH FOLLOW-UP CT ON THE (B)(6) 2019 THAT A TYPE IIIA ENDOLEAK WAS OBSERVED. THE ENDOLEAK WAS ALSO OBSERVED ON SUBSEQUENT YEARLY FOLLOW UP CTS. ON RECENT CT, THE SAC INCREASED FROM 82CM TO 85CM (NO GROWTH IN PREVIOUS SCANS). THE ANEURYSM ENLARGEMENT WAS STABLE ON MOST RECENT CT. IT IS REPORTED THE PATIENT IS HIGH RISK FOR INTERVENTION DUE TO THE PATIENTS LUNGS. AS PER THE PHYSICIAN THE CAUSE OF TYPE IIIA ENDOLEAK CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13365934 ↗
• MalfunctionApr 28, 2021Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC ULCER. IT WAS REPORTED A CT REVIEW OBSERVED TYPE IA, IB <(>&<)> IIIB ENDOLEAKS WITH STENT RING ENLARGEMENT ON CT IMAGES FROM THE 8 MONTH FOLLOW UP. IT WAS REPORTED THE PHYSICIAN HAS BEEN NOTIFIED OF THE EVENT BUT THE PATIENT HAS BEEN LOST TO FOLLOW UP. ATTEMPTS HAVE BEEN MADE TO CONTACT THE PATIENT SINCE THE YEAR OF IMPLANT BUT THE PATIENT HAS OPTED TO HOLD OFF ON CT IMAGING. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11736225 ↗
• InjuryApr 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT CAPTIVIA AND NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 67.8MM X 78.5MM THORACIC ANEURYSM. APPROX. 1 YEAR 8 MONTHS POST INDEX, AN ADDITIONAL 2 VALIANT NAVION DEVICES WERE IMPLANTED FOR AN UNKNOWN PROCEDURE IT WAS REPORTED THE CORE LAB OBSERVED THE FOLLOWING AFTER ANALYSIS OF THE 12M, INTERIM <(>&<)> 24M CTS: TYPE IIIB ENDOLEAK OF V07404460 VALIANT CAPTIVIA DEVICE <(>&<)> TYPE IIIA ENDOLEAK BETWEEN V08146953 AND V08097833 NAVION DEVICES. MOREOVER, 7 STENT FRACTURES (6 FRACTURES IN MOST DISTAL STENT AND 1 FRACTURE IN SECOND MOST DISTAL STENT) <(>&<)> STENT ENLARGEMENT IN SECOND STENT RING OF V08097833 NAVION DEVICE. NO CAUSE OF THE EVENT WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 11714972 ↗
• InjuryMar 27, 2021Leak/Splash; Migration or Expulsion of Device; Material Deformation; Leak/Splash; Migration or Expulsion of Device; Material Deformation

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A RUPTURED THORACIC AORTIC ANEURYSM. IT WAS REPORTED ON THE DATE OF THE CT APPROXIMATELY 17 MONTHS POST IMPLANT, A POTENTIAL TYPE IIIB OR TYPE IA ENDOLEAK WAS PRESENT IN THE PROXIMAL AREA OF THE GRAFT. THE ANEURYSM HAD EXPANDED FROM 50MM TO 70MM. INTERVENTION WAS PERFORMED AND THE STENT GRAFT WAS RELINED PROXIMALLY. IT ALSO WAS STATED THERE LOOKED TO BE STENT RING ENLARGEMENT IN A DIFFERENT AREA OF THE GRAFT IT WAS REPORTED IT WAS REPORTED IT LOOKED LIKE THE STENT HAD COME OFF THE GRAFT. THE PATIENT HAD BEEN COMPLAINING OF CHEST PAIN. A CT WAS PERFORMED POST THE SECONDARY PROCEDURE AND IT WAS NOTED THE ANEURYSM HAD ENLARGED FURTHER SO THERE MAY BE STILL AN ENDOLEAK, ALTHOUGH THE PHYSICIAN NOTED THERE WAS NOTHING OBVIOUS ON THE COMPLETION ANGIOGRAM AFTER THE INTERVENTION. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Pain

  MAUDE report 11580173 ↗
• MalfunctionJan 30, 2020Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS INTENDED IT TO BE USED IN AN UNKNOWN THORACIC ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT PRIOR TO THE INDEX PROCEDURE WHEN THE DEVICE WAS BEING PREPPED, THE INTEGRATED FLUSH PORT WOULD NOT ALLOW FLUID TO PASS THROUGH IT. THIS DEVICE WAS THEN DISCARDED AND REPLACED WITH A NEW DEVICE AND THE PROCEDURE COMPLETED SUCCESSFULLY. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9646689 ↗
• InjuryOct 30, 2019Material Deformation; Material Deformation

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR THORACIC ANEURYSM. CALCIFICATION OF THE RENAL ARTERIES AND INFRARENAL AORTA WAS NOTED WITH A NARROW DISTAL AORTA MEASURING 15MM. IT WAS REPORTED DURING THE INDEX PROCEDURE AFTER THE STENT GRAFT WAS DEPLOYED, THE DISTAL ASPECT OF THE GRAFT INFOLDED. AN ADDITIONAL GRAFT WAS IMPLANTED TO COVER THE INFOLDED PART AND THE PROCEDURE COMPLETED SUCCESSFULLY. PER THE PHYSICIAN THE CAUSE OF THE INFOLDING IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9254685 ↗