Valiant Navion™ VNMF3131C97TU (UDI 00763000100599)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000100599), received between May 1, 2019 and May 16, 2022 — classified as 1 death, 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 16, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A TYPE IA ENDOLEAK.  IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THE PATIENT RETURNED FOR A FOLLOW-UP CT. A TYPE III ENDOLEAK AND AORTIC ENLARGEMENT OF 6.5->6.6 WAS NOTED. AS PER THE PHYSICIAN THE TYPE III ENDOLEAK MAY BE ON A NON-MDT DEVICE.  NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 14406936 ↗
• MalfunctionJan 4, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM WITH A PENETRATING THORACIC ULCER. IT WAS REPORTED THE PATIENT RETURNED FOR A FOLLOW-UP CT APPROXIMATELY 19 MONTHS LATER WHERE IT WAS DISCOVERED THAT THERE WAS ANEURYSMAL DILATION/PENETRATING ULCERATION NEAR THE LEVEL OF THE DESCENDING AORTIC GRAFT WHICH HAS SIGNIFICANTLY INCREASED MEASURING UP TO 56MM AT THE PROXIMAL MARGIN OF THE GRAFT WITH ASSOCIATED ENDOLEAK AROUND THE GRAFT. THE AORTA MEASURES UP TO 51MM AT THE LEVEL OF DISTAL MARGIN OF THE GRAFT WITH ASSOCIATED ENDOLEAK AROUND THE DISTAL STENT. THE ANEURYSM MAY HAVE AN INFLAMMATORY COMPONENT GIVEN SOME EROSION ALONG THE ANTERIOR MARGIN OF THE T10 VERTEBRAL BODY. THE AORTA AT THE LEVEL OF THE HIATUS MEASURES UP TO 53MM , PREVIOUSLY 34MM. NO CAUSE OF EVENT AS PER THE PHYSICIAN HAS BEEN PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE HAS BEEN PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm

  MAUDE report 13151047 ↗
• DeathNov 10, 2021Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT CORE LAB IDENTIFIED A TYPE II ENDOLEAK FROM AN IMAGE THAT WAS DATED 4 MONTHS LATER, CORE LAB REPORTED NO STENT RING ENLARGEMENT, NO FRACTURES AND NO OTHER ENDOLEAKS. DURING FOLLOWING UP FROM THE CORE LAB'S OBSERVATIONS OF A TYPE II ENDOLEAK, IT WAS REPORTED THE PATIENT PASSED AWAY JUST OVER A YEAR LATER WITH NO OTHER SPECIFIC DETAILS. THE CAUSE OF DEATH IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AND THE PATIENT HAS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 12785352 ↗
• InjuryNov 12, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF PAU (PENETRATING ATHEROSCLEROTIC ULCER) AND IMH (INTRAMURAL HEMATOMA) OF THE THORACIC AORTA. IT WAS REPORTED THAT AFTER THE PROCEDURE WAS COMPETED, COMPLETION ANGIOGRAM SHOWED EXCLUSION OF THE PAU. IT WAS REPORTED THAT CTA CARRIED OUT 5 DAYS POST INDEX PROCEDURE, PRIOR TO DISCHARGE, SHOWED A NEW DISSECTION PROXIMAL TO THE THORACIC STENT GRAFT AND THE IMH APPEARED TO HAVE INCREASED WITH MORE ADDITIONAL INVOLVEMENT OF THE TRANSVERSE ARCH. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Intimal Dissection

  MAUDE report 9309219 ↗
• InjuryMay 1, 2019Malposition of Device; Malposition of Device

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ULCER. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE DEVICE WAS NOT IMPLANTED AT THE DESIRED LANDING POSITION, DUE TO POSITIONING DIFFICULTIES. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO THE CALCIFIED PATIENT ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury; No Consequences Or Impact To Patient

  MAUDE report 8568940 ↗