Valiant Navion™ VNMF4040C62TU (UDI 00763000100704)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000100704), received between May 7, 2020 and Sep 27, 2023 — classified as 1 death, 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 27, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION ON (B)(6) 2019. IT WAS REPORTED DURING FOLLOW-UP CT IMAGING, TAKEN ON THE (B)(6) 2019 AND REVIEWED BY CORELAB. A TYPE IA ENDOLEAK WAS IDENTIFIED ON STENT GRAFT (B)(6) (NEW), WITH NO OBSERVED STENT RING ENLARGEMENT. FRACTURES AND STENT RING MIGRATION WERE NOT EXAMINABLE DUE TO DEVICE OVERLAPS . THE MAXIMUM AORTIC DIAMETER MEASURED AT 84.2MM. A SUBSEQUENT CT SCAN ON (B)(6) 2019, REVIEWED BY CORELAB, REVEALED A TYPE IA ENDOLEAK (PERSISTENT) ON STENT GRAFT (B)(6), WITH NO STENT RING ENLARGEMENT , STENT RING MIGRATION OR FRACTURE OBSERVED . THE MAXIMUM AORTIC DIAMETER MEASURED 113.0MM, INDICATING A NEW AORTIC ENLARGEMENT OF +28.8MM. FURTHER FOLLOW-UP IMAGING ON (B)(6) 2019 AND (B)(6) 2019, REVIEWED BY CORELAB, CONFIRMED THE TYPE IA ENDOLEAK (PERSISTENT) ON STENT GRAFT (B)(6), WITH NO STENT RING ENLARGEMENT, STENT RING MIGRATION OR FRACTURE OBSERVED. THE MAXIMUM AORTIC DIAMETER MEASURED 115.0MM, WITH THE AORTIC ENLARGEMENT INCREASE TO +30.8MM (PERSISTENT) . ON (B)(6) 2019 A CT IMAGING REVIEWED BY CORELAB, CONTINUED TO REVEAL THE PERSISTENCE OF A TYPE IA ENDOLEAK ON VNMF4040C62TU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17826215 ↗
• MalfunctionFeb 24, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED FROM A CT TAKEN THAT A TYPE I ENDOLEAK FROM THE AORTIC NECK AND TYPE II ENDOLEAK FROM A PATENT LUMBAR VESSEL WERE OBSERVED. NO CAUSE OF THE TYPE IA ENDOLEAK WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13589933 ↗
• DeathJun 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION WAS THEN IMPLANTED IN A PATIENT. IT WAS REPORTED THE PATIENT EXPIRED ABOUT 2 WEEKS LATER DUE TO AN UNKNOWN CAUSE. THE PATIENT HAD BEEN TRANSFERRED TO ANOTHER FACILITY AND LOST TO FOLLOW-UP. IT WAS SAID IT COULD NOT BE DETERMINED IF THE DEVICE CONTRIBUTED TO THE PATIENTS DEATH. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 12082754 ↗
• InjuryMay 7, 2020Leak/Splash; Leak/Splash

  AN ENDURANT IIS STENT GRAFT SYSTEM AND VALIANT NAVION STENT GRAFT WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A TYPE III ENDOLEAK IN A NON-MDT STENT GRAFT. THE ENDURANT IIS STENT GRAFT SYSTEM WAS USED TO RE-LINE THE NON-MDT STENT GRAFT AND THE VALIANT NAVION WAS PLACED AS A CUFF OUT OF THE ENDURANT IIS TO RESOLVE THE ENDOLEAK. IT WAS REPORTED THAT THE PATIENTS SIX-MONTH CT SCAN SHOWED A TYPE IA ENDOLEAK. APPROXIMATELY THREE WEEKS LATER AN ENDURANT II STENT GRAFT CUFF ETTF3636C70E WAS PLACED AT THE LEVEL OF THE SMA AND EXTENDED TO THE MAIN STENT GRAFT BODY. THERE WAS NO ENDOLEAK OBSERVED POST-PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS DUE TO DISEASE PROGRESSION AND A FAILED NON-MDT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 10032046 ↗