Valiant Navion™ VNMC3131C90TU (UDI 00763000260767)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000260767), received between Dec 23, 2020 and Dec 11, 2023 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

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

  A VALIANT NAVION STENT GRAFT (VNMC3131C90TU) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING FROM 2 APPROXIMATELY 2 MONTHS POST THE INDEX PROCEDURE IDENTIFIED A NEW UNKNOWN TYPE ENDOLEAK ON VNMC3131C90TU. NO STENT RING ENLARGEMENT, STENT RING MIGRATION OR STENT FRACTURE WERE OBSERVED. THE MAXIMUM AORTIC DIAMETER MEASURED AT 75.4MM. THE CAUSE OF THE ENDOLEAK IS UNDETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18299997 ↗
• InjuryMar 6, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION.  IT WAS REPORTED THAT ON THE DATE OF THE EVENT, THE PATIENT HAD AWAKENED IN THE MIDDLE OF THE NIGHT WITH COUGHING AND VOMITING AND EXPERIENCING EXCRUCIATING ABDOMINAL PAIN THAT DID NOT SUBSIDE. THE  PATIENT PRESENTED TO OUTSIDE ER AND HAD CT SCAN WHICH  SHOWED A WORSENING DISTAL THORACIC AND PROXIMAL ABDOMINAL AORTIC ANEURYSM WITH CONCERN FOR CONTAINED RUPTURE DUE TO EXTENSIVE PAIN.  FIVE DAYS LATER THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY FOR FOLLOW-UP. THE PATIENT HAD A OPEN THORACOABDOMINAL REPAIR OF A FURTHER FOUR DAYS LATER AS TREATMENT. THE PATIENT REQUIRED IN PATIENT OR PROLONGED HOSPITISATION.  THE EVENT RESOLVED. THE SITE ASSESSED THE ANEURYSM AS NOT RELATED TO THE STUDY DEVICE, PROCEDURE OR DISSECTION UNDER STUDY.  THE SPONSOR ASSESSED IT AS RELATED TO THE STUDY DEVICE, NOT RELATED TO THE STUDY PROCEDURE AND RELATED TO THE DISSECTION UNDER STUDY.  NO ADDITIONAL CLINICAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; Pain; Rupture; Vascular Dissection; Vomiting

  MAUDE report 16485975 ↗
• InjuryDec 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION.  IT WAS REPORTED THE PATIENT PRESENTED TO AN  OUTSIDE FACILITY WITH CHEST AND EPIGASTRIC PAIN RADIATING TO THE BACK. THE PATIENTS BLOOD PRESSURE WAS 207/86, PAIN MEDS AND IV MEDICATION WAS GIVEN. 2 DAYS LATER THE PAIN CONTINUED TO BE DIFFICULT TO CONTROL AND PATIENT WAS TRANSFERRED TO THEIR OWN FACILITY.  A CTA PERFORMED  SHOWED INTERVAL PROGRESSION OF TYPE B AORTIC DISSECTION WITHIN THE LOWER DESCENDING TO SUPRARENAL ABDOMINAL AORTA BEYOND THE THORACIC ENDOGRAFT. THIS EXTENDS TO APPROXIMATELY THE LEVEL OF THE CELIAC ARTERY.  THE SITE ASSESSED THIS DISSECTION AS UNLIKELY RELATED TO THE STUDY DEVICE, NOT RELATED TO THE STUDY PROCEDURE AND PROBABLY RELATED TO THE DISSECTION UNDER STUDY.  THE MEDICAL MONITOR ASSESSED IT AS RELATED TO THE STUDY DEVICE, NOT RELATED TO THE STUDY PROCEDURE AND RELATED TO THE DISSECTION UNDER STUDY.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Abdominal Pain; Chest Pain; Fatigue; Fever; Vascular Dissection

  MAUDE report 15948452 ↗
• DeathJan 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AORTIC DISSECTION ON THE (B)(6) 2020. IT WAS REPORTED APPROXIMATELY 4 MONTHS POST THE INDEX PROCURE THE PATIENT SUFFERED FROM CARDIAC ARREST AND THE PATIENT HAS EXPIRED. THE SITE HAVE ASSESSED THE CARDIAC ARREST AND DEATH AS POSSIBLY RELATED TO THE STUDY DEVICE, POSSIBLE RELATED TO THE DISSECTION AND NOT RELATED TO THE PROCEDURE. THE MEDICAL MONITOR HAS ASSESSED THE CARDIAC ARREST AND DEATH AS NOT DEVICE, PROCEDURE OR DISSECTION RELATED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Cardiac Arrest

  MAUDE report 13280331 ↗
• InjuryDec 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A AORTIC DISSECTION. IT WAS REPORTED TWO DAYS LATER, THE PATIENT WAS NOTED TO HAVE WEAKNESS IN THE LOWER EXTREMITIES . A LUMBAR DRAIN WAS PLACED AND THE PATIENT'S BP WAS MAINTAINED WITH MEDICATION. 5 DAYS LATER, THE LOWER EXTREMITY WEAKNESS APPEARED TO BE RESOLVED AND THE LUMBAR DRAIN WAS REMOVED. A FURTHER 3 DAYS LATER AS THE PATIENT WAS BEING TRANSFERRED TO A DIFFERENT WARD, THE WEAKNESS RETURNED. THE PATIENT WAS MOVED BACK TO ICU WITH THE LOWER EXTREMITY WEAKNESS AND URINARY RETENTION. A LUMBAR DRAIN WAS PLACED FOR THECAL SAC DECOMPRESSION. BY THAT EVENING THE PATIENT WAS ABLE TO LIFT THEIR LEGS OFF THE BED. THE SITE ASSESSED THE EVENT AS NOT RELATED TO DEVICE OR PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS RELATED TO DEVICE AND PROCEDURE. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Muscle Weakness/Atrophy; Urinary Retention

  MAUDE report 11064297 ↗