Valiant Navion™ VNMF2525C96TU (UDI 00763000100551)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000100551), received between Apr 17, 2019 and Dec 14, 2022 — classified as 1 death, 1 injury, 3 malfunctions.

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 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.

• InjuryDec 14, 2022Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZE TAA. IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY TO EMERGENCY ROOM APPROXIMATELY 2 YEARS AND 11 MONTHS POST INDEX PROCEDURE WITH COMPLAINTS OF CHEST PAINS. A COMPUTED TOMOGRAPHY PERFORMED REVEALED A LARGE MID DESCENDING THORACIC AORTIC ANEURYSM. THE PHYSICIAN NOTED THAT A TYPE 1B OR TYPE III ENDOLEAK MAY BE OCCURRING INVOLVING THE PIECE PLACED MOST DISTAL. THIS STENT GRAFT WAS CONFIRMED AS THE (B)(4). IT WAS SAID THIS 3RD DISTAL PIECE HAD BEEN PLACED JUST PROXIMAL TO THE CELIAC ARTERY DURING THE INDEX PROCEDURE. INTERVENTION WAS PERFORMED THE FOLLOWING DAY, 3 VALIANT CAPTIVIA'S WERE IMPLANTED VAMF2828C150T (V30592263) WAS IMPLANTED MOST PROXIMAL FOLLOWED BY VAMF2828C150TU (V30592262) & VAMF2828C100TU (V30592478). IN ADDITION TO LANDING AT THE CELIAC, 5 ENDOANCHORS WERE PLACED IN MOST DISTAL ASPECT OF THAT GRAFT. A TYPE III ENDOLEAK WAS RULED OUT DURING THE INTERVENTION. PER THE PHYSICIAN THE CAUSE OF THE EVENT IS THAT THE STENT GRAFT APPEARED TO HAVE SHORTENED OR MOVED SOMEHOW, EXPOSING 3 CM OF AORTA AND LEADING TO AN ENDOLEAK, WITH SAC FILLING. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVI

  Patient problems: Pain

  MAUDE report 15976649 ↗
• MalfunctionNov 17, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 81MM THORACIC ANEURYSM THAT HAD PRE-RUPTURED WITH A DISSECTION. THE PATIENT HAD 3 EXISTING VALIANT NAVION GRAFTS IMPLANTED 6 MONTHS PREVIOUSLY DURING AN UNKNOWN PROCEDURE. IT WAS REPORTED 2 DAYS POST THE PROCEDURE, CT IDENTIFIED A TYPE I ENDOLEAK INVOLVING THE DISTAL ASPECT OF THE ENDOGRAFT WITHIN THE S UPRARENAL ABDOMINAL AORTA. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Vascular Dissection

  MAUDE report 15814037 ↗
• MalfunctionJul 22, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE . IT WAS REPORTED THAT AN UNDETERMINED ENDOLEAK WAS NOTED ON THE SAME DATE. NO CAUSE AS PER THE PHYSICIAN WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15084185 ↗
• DeathMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION AND VALIANT CAPTIVIA STENT GRAFT WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THE PATIENT EXPIRED 37 DAYS AFTER THE INDEX PROCEDURE. IT WAS REPORTED THERE MAY HAVE BEEN AORTIC ENLARGEMENT NOTED WITH THE STENT IN PLACE. NO CAUSE OF DEATH HAS BEEN PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 14469290 ↗
• MalfunctionApr 17, 2019Material Deformation; Material Deformation

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN AORTIC ULCER. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE PRIOR TO USE OF THE DEVICE IN THE PATIENT, THE PHYSICIAN ELECTED TO MODIFY THE DEVICE ON THE BACK TABLE, REDUCING THE LENGTH OF THE STENT GRAFT BY ONE STENT RING. THE DELIVERY SYSTEM SHEATH WAS RETRACTED TO EXPOSE THE STENT GRAFT, AND SUTURE TIES WERE APPLIED TO KEEP THE STENT GRAFT FROM EXPANDING. THE DISTAL STENT RING WAS REMOVED USING AN EYE CAUTERY TO CUT THE MATERIAL. THE SHEATH WAS THEN ADVANCED BACK OVER THE STENT GRAFT, AND THE SUTURES HOLDING THE STENT GRAFT IN PLACE WERE CUT AS THE SHEATH PROGRESSED. AT THIS POINT, A SNAPPING SOUND WAS HEARD BY THE PHYSICIAN AND A SPLIT WAS NOTED ON THE PROXIMAL DELIVERY SYSTEM SHEATH, NEAR THE RO MARKER BAND. THE PHYSICIAN THEN INSERTED THE MODIFIED DEVICE VIA AN 18 FR NON-MEDTRONIC SHEATH TO AVOID HAVING THE SPLIT DEVICE MOVE UP THROUGH T HE AORTA. THE STENT GRAFT WAS THEN SUCCESSFULLY IMPLANTED IN AN INFRA-RENAL POSITION WITH NO COMPLICATIONS. THE DEVICE DELIVERY SYSTEM WAS THEN REMOVED THROUGH THE 18 FR SHEATH. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8522198 ↗