Valiant Navion™ VNMC4343C55TU (UDI 00763000101121)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000101121), received between Feb 22, 2019 and Jan 13, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (2 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.

• MalfunctionJan 13, 2023Leak/Splash; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA   IT WAS REPORTED ON THE DATE OF THE CT, AN UNDETERMINED ENDOLEAK WAS IDENTIFIED.  NO CAUSE WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16155714 ↗
• MalfunctionNov 23, 2022Leak/Splash; Leak/Splash

  VALIANT  NAVION STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A DISSECTION .  IT WAS REPORTED THAT A FOLLOW UP CT PERFORMED 3 MONTHS LATER, IDENTIFIED A TYPE I ENDOLEAK AND AORTIC ENLARGEMENT WITH INCREASED DIAMETER OF ASCENDING AORTA MEASURING 52 MM.  IT WAS REPORTED THE PATIENT EXPIRED THE FOLLOWING YEAR. NO MORE SCANS WERE PERFORMED PRIOR TO THE PATIENT DEATH. THE CAUSE OF THE ENDOLEAK IS UNKNOWN. THE CAUSE OF THE DEATH WAS NOT PROVIDED. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT IS EXPIRED.

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

  MAUDE report 15851612 ↗
• MalfunctionMar 12, 2019Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ULCER. IT WAS REPORTED THAT AFTER DEPLOYMENT OF THE STENT GRAFT IN THE ASCENDING AORTA, WHEN THE PHYSICIAN WAS ATTEMPTING TO REMOVE THE DELIVERY SYSTEM, THE STENT GRAFT WAS PULLED DISTALLY. AFTER SEVERAL ATTEMPTS, THE PHYSICIAN WAS ABLE TO REMOVE THE DELIVERY SYSTEM WITHOUT PULLING THE STENT GRAFT ANY FURTHER DISTALLY. THE STENT GRAFT POSITION WAS FURTHER DISTAL THAN INITIALLY INTENDED, BUT THE PHYSICIAN WAS SATISFIED WITH THE FINAL LOCATION. THREE STENT GRAFTS IN TOTAL WERE DEPLOYED IN THE ASCENDING AORTA DURING THE PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8411371 ↗
• InjuryFeb 22, 2019Malposition of Device; Activation, Positioning or Separation Problem; Malposition of Device; Activation, Positioning or Separation Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 65MM THORACIC ANEURYSM. IT WAS NOTED THE PATIENT HAD A PREVIOUS OPEN AORTIC BI FEMORAL REPAIR AND THERE WERE STENTS PLACED IN THE LIMBS OF THE OPEN REPAIR GRAFT. IT WAS REPORTED DURING THE INDEX PROCEDURE SEVERAL ATTEMPTS WERE MADE TO ADVANCE THE DEVICE THROUGH THE PATIENTS LEFT LIMB DUE TO RESISTANCE. A 22FR SHEATH WAS THEN ADVANCED AS FAR AS POSSIBLE THROUGH THE LIMB AND THE DEVICE WAS REINSERTED THROUGH THE SHEATH INTO THE AORTA. THE DEVICE WAS DEPLOYED WITHOUT DIFFICULTY BUT THE MIDDLE OF THE STENT GRAFT FAILED TO OPEN. THE DELIVERY SYSTEM WAS REMOVED AND THE PHYSICIAN ATTEMPTED TO BALLOON THE DEVICE TO GET IT TO OPEN BUT THERE APPEARED TO BE A 5MM SECTION THAT WAS CONSTRAINED TO ABOUT 16MM. UNDER FLUOROSCOPY A SECTION OF THE ILIAC STENT WAS OBSERVED TO BE STUCK ON THE STENT GRAFT LEADING TO THE GRAFT BEING CONSTRAINED. SEVERAL ATTEMPTS WERE MADE TO BALLOON OUT THE STENT TO BREAK IT AWAY FROM THE GRAFT BUT THEY WERE UNSUCCESSFUL . DUE TO THE STENT CONSTRAINING THE GRAFT, THE DISTAL END OF THE GRAFT DID NOT LAND IN THE INTENDED PLACE. THE PHYSICIAN ELECTED TO IMPLANT A 43X55 NAVION STENT TO EXT

  Patient problems: Injury

  MAUDE report 8361152 ↗