Valiant Navion™ VNMF2828C97TURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000100575), received between Jul 20, 2020 and Mar 1, 2023 — classified as 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Deformation” (2 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 16, 2026.

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.

• InjuryMar 1, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 13 MONTHS POST THE INDEX PROCEDURE, FOLLOW UP CT IDENTIFIED A TYPE IB ENDOLEAK LOCATED APPROXIMATELY 30MM ABOVE THE CELIAC ACCESS. INTERVENTION WAS COMPLETED WHERE A NON MDT STENT GRAFT WAS IMPLANTED IN THE DISTAL DESCENDING THORACIC AORTA. COMPLETION ANGIOGRAM SHOWED EXCELLENT SEALING OF THE GRAFT AND A COMPLETE SEAL OF THE ENDOLEAK. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE, THE PATIENT COMPLAINED OF PAIN AT REST IN THE LEFT LOWER EXTREMITY AND PAIN WITH WALKING. FOLLOW UP DETERMINED THE PATIENT HAD AN IN-FLOW ISSUE PRESUMABLY FROM THE PATCH CLOSURE. THE PHYSICIAN ELECTED TO COMPLETE AN ANGIOGRAM WITH REVASCULARIZATION ON THIS DATE. A 8X100MM SELF-EXPANDING STENT WAS PLACED UP TO THE ILIAC BIFURCATION ON THE LEFT. THE PATIENT STATUS HAS BEEN REPORTED AS DOING WELL POST THIS PROCEDURE. THE CAUSE OF THE TYPE IB ENDOLEAK WAS NOT PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Obstruction/Occlusion

  MAUDE report 16458177 ↗
• MalfunctionNov 10, 2022Material Deformation; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING REINTERVENTION FOR A PRIOR AORTIC REPAIR. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING FROM 01-OCT-2021 & 13-OCT-2021 NOTED AN OBSERVATION OF THE PRESENCE OF INTRALUMINAL THROMBUS AND NARROWING OF DEVICE AT THE PROXIMAL END JUST DISTAL TO AORTIC BRANCH VESSELS. NO ENDOLEAK, STENT RING ENLARGEMENT OR AORTIC ENLARGEMENT WAS OBSERVED. THE IMAGING WAS NOTED AS NE FOR FRACTURE DUE TO SCAN QUALITY AND DEVICE OVERLAPS. THE CAUSE OF THE INTRALUMINAL THROMBUS AND NARROWING IS UNDERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 15770388 ↗
• InjuryNov 2, 2022Material Deformation; Material Deformation

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE.  IT WAS REPORTED ON THE DATE OF THE CT, AORTIC ENLARGEMENT WAS IDENTIFIED. THE RADIOLOGIST REVIEWED THE IMAGING AND NOTED A NEW FOCAL TYPE B DISSECTION OF THE PROXIMAL DESCENDING THORACIC AORTA WITHIN THE ENDOGRAFT. IT WAS REPORTED THAT IT SEEMS HIGHLY PROBABLE THAT THE LONGITUDINAL SEAM HAS GIVEN WAY ON THE STENT GRAFT IMPLANT. PER THE PHYSICIAN  THE CAUSE IF THE EVENT IS A DEVICE FAILURE.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm; Vascular Dissection

  MAUDE report 15714605 ↗
• MalfunctionJul 20, 2020Premature Activation; Premature Activation

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 60MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THAT THE FREE FLOW PROXIMAL STENT OF THE DEVICE DEPLOYED AUTOMATICALLY DURING THE UNSHEATHING OF THE GRAFT COVER. IT WAS STATED THE TIP CAPTURE MECHANISM WAS NOT INTERFERED WITH PRE- DEPLOYMENT AND REMAINED THE LOCKED POSITION THROUGHOUT DEPLOYMENT AND THERE WAS NO ATYPICAL RESISTANCE DURING THE DELIVERY NOTED. THERE WAS NO CONSEQUENCES TO THE DELIVERY OR ACCURATE PLACEMENT OF THE DEVICE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10294686 ↗