Valiant Navion™ VNMC3428C207TU (UDI 00763000261023)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000261023), received between Nov 3, 2020 and Oct 11, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 11, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE TREATMENT ON A TAA ON THE (B)(6) 2020. 4 VALIANT NAVION STENT GRAFTS IMPLANTED IN TOTAL, FROM PROXIMAL TO DISTAL VNMC3434C90TU, VNMC3131C223TU,VNMC2525C94TU WERE IMPLANTED ON THE (B)(6) 2020. THE FINAL NAVION VNMC3428C207TU WAS IMPLANTED ONE MONTH LATER FOR THE ABDOMINAL AORTA FOR THE TREATMENT OF A AAA. IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN ON THE (B)(6) 2023 SHOWED A TYPE IIIB ENDOLEAK IN THE NAVION STENT GRAFTVNMC3131C223TU V29818675. CORE LAB REVIEW OF CT IMAGING FROM (B)(6) 2023 IDENTIFIED A NEW TYPE IIIB ENDOLEAK IN VNMC3131C223TU (V29818675) AND VNMC3428C207TU (V29961271). A NEW STENT FRACTURE WAS IDENTIFIED ON RING 4 OF VNMC3131C223TU (V29818675). NEW SRE WAS REPORTED OF +4.3MM ON RING 4 OF VNMC3131C223TU (V29818675) AND + 2.0MM TO RING 5 OF VNMC3131C223TU (V29818675). NO STENT RING MIGRATION WAS OBSERVED. THE MAX AORTIC DIAMETER WAS NOTED AS 70.9MM. THE IMAGING WAS NOTED AS NA FOR AORTIC ENLARGEMENT AND NON EVALUABLE FOR SOME GRAFTS FOR STENT FRACTURES AND STENT RING MIGRATION DUE TO DEVICE OVERLAPS. THE STENT GRAFT WAS RELINED USING A VALIANT CAPTIVIA STENT GRAFT AND THE ENDOLEAK WAS CONFIRNED AS RESOLVED. PER THE PHYS

  Patient problems: Insufficient Information

  MAUDE report 17910928 ↗
• InjuryNov 3, 2020Malposition of Device; Malposition of Device

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 245 MM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE DEVICE WAS DEPLOYED UNDER FLUOROSCOPIC VISUALIZATION IN THE DESCENDING THORACIC AORTA FOR A TYPE B AORTIC DISSECTION. DELIVERY SYSTEM WAS REMOVED AND A 16 FRENCH SHEATH WAS PLACED OVER THE WIRE. IT WAS STATED THAT A NON-MEDTRONIC CATHETER WAS INTRODUCED AND IT WAS DETERMINED THAT THE GRAFT HAD MIGRATED. THE VALIANT NAVION STENT GRAFT WAS THEN EXPLANTED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: Injury; Insufficient Information

  MAUDE report 10777258 ↗