Valiant Navion™ VNMC3131C182TU (UDI 00763000100988)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000100988), received between Feb 22, 2019 and Aug 28, 2024 — classified as 3 deaths, 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Feb 12, 2021Class IOpen, Classified

   Due to the presence of type IIIb endoleaks, stent fractures, and stent ring enlargement.

   Z-1201-2021 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryAug 28, 2024Fracture; Fracture

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED, DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED, APPROXIMATELY 6 YEARS POST, THE INDEX PROCEDURE. THAT THE PATIENT, RANG TECHNICAL SERVICES AND STATED, THAT THE VALIANT NAVION STENT GRAFT WAS FRACTURED. THE PATIENT STATED, THAT THEY HAD BLEEDING ISSUES, BUT THAT THEY DON'T KNOW WHERE IT'S COMING FROM. THE PATIENT, ALSO HAD SHORTNESS OF BREATH AND PRESSURE IN THEIR BACK. THE PATIENT SAID, THAT THE PHYSICIAN SENT A LETTER STATING, THAT THE STENT GRAFT IS BROKEN AND IS UNDER RECALL FOR POSSIBLE FRACTURES. THE PATIENT HAD A 6 MONTH FOLLOW UP WITH THE PHYSICIAN, BUT NO INTERVENTION WAS PERFORMED. THE PATIENT STATED, THAT ULTRASOUNDS HAVE BEEN TAKEN AND THAT THEY CAUSE PAIN. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20084119 ↗
• InjuryMay 5, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT IDENTIFIED A SMALL ENDOLEAK TO THE LEFT OF THE DISTAL THORACIC PORTION OF THE GRAFT. ANOTHER ENDOLEAK TO THE LEFT SIDE OF THE DISTAL PORTION OF THE GRAFT. AN ENDOLEAK PROXIMALLY AT THE LEVEL OF AORTIC STENT BIFURCATION INTO ILIAC VESSELS. ALL OF ENDOLEAKS ARE UNDETERMINED TYPE. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 16875027 ↗
• DeathJan 16, 2023Leak/Splash; Leak/Splash

  A  VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA.  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY , AFTER DEVELOPING WORSENING BACK PAIN, ALTERED MENTAL STATUS, A FEVER OF 104 AND H EMOPTYSIS. A CT WAS PERFORMED WHICH SHOWED A POSSIBLE ENDOLEAK AND A STENT GRAFT INFECTION AND ABSCESS.  THE PATIENT DIED 10 DAYS LATER FROM THE STENT GRAFT INFECTION AND SEPSIS. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS AN INFECTION FROM THE GRAFT.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Abscess; Fever; Hemoptysis; Pain; Sepsis; Unspecified Infection

  MAUDE report 16173037 ↗
• MalfunctionJan 26, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM OF AN UNKNOWN SIZE.  IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE THE PATIENT RETURNED FOR A FOLLOW-UP CT WHERE THE PRESENCE OF A UNKNOWN ENDOLEAK WITH ANEURYSM ENLARGEMENT WAS NOTED. 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 13360667 ↗
• InjuryMay 4, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. APPROXIMATELY SEVEN (7) MONTHS POST INDEX PROCEDURE, A DISTAL LEAK OF THE DEVICE WAS REPORTED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 11769990 ↗
• DeathOct 14, 2020Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION. THE DISSECTION MEASURED FROM THE LSA TO ILIAC BIFURCATIONS. IT WAS REPORTED APPROXIMATELY 4 MONTHS POST THE INDEX PROCEDURE, FOLLOW UP CT DEMONSTRATED THAT THE GRAFT WAS DISTAL TO THE LCCA AND HAD A TYPE IA ENDOLEAK. DURING THE INITIAL PROCEDURE THE GRAFT APPEARED TO BE 5MM DISTAL TO THE LCCA AND THE FINAL ANGIOGRAM CONFIRMED SEAL AND THE DECISION WAS MADE NOT TO EXTEND AT THAT TIME HOWEVER NOW THE GRAFT APPEARS TO HAVE MIGRATED DISTAL LEADING TO A TYPE IA ENDOLEAK. THE PATIENT UNDERWENT AORTIC ARCH DEBRANCHING AND ENDOGRAFT PLACEMENT FROM THE ASCENDING AORTA INTO THE EXISTING DESCENDING THORACIC GRAFT. VNMC4034C200TU ((B)(4)) WAS USED. IT WAS THEN REPORTED ONE DAY LATER THE PATIENT STARTED BLEEDING OUT OF THE MEDIASTINAL TUBE. THE PATIENT WAS RUSHED TO THE OPERATING ROOM AND OPENED WHERE IT WAS NOTED THAT THE PROXIMAL END OF THE GRAFT HAD PERFORATED THE AORTA. MULTIPLE REPAIR STITCHES WERE PLACED BUT WOULD NOT HOLD IN THE FRAGILE AORTA AND THE PATIENT CONTINUED TO SUFFER BLOOD LOSS AND EXPIRED. PER THE PHYSICIAN THE CAUSE OF THE MIGRATION WAS USER ERROR.

  Patient problems: Blood Loss; Death; Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 10676701 ↗
• DeathNov 27, 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 A 650MM ABDOMINAL THORACIC DISSECTION. IT WAS REPORTED THAT 5 MONTHS LATER THE PATIENT PRESENTED EMERGENTLY WITH CHEST PAIN AND LATER DIED IN THE EMERGENCY ROOM BEFORE ANY STENT GRAFT COULD BE IMPLANTED. AS PER THE PHYSICIAN, DISEASE PROGRESSION DISTALLY WAS IDENTIFIED WITH THE CAUSE OF DEATH RELATED TO RUPTURE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Death; Pain; Rupture

  MAUDE report 9382085 ↗
• MalfunctionFeb 22, 2019Migration or Expulsion of Device; Malposition of Device; Migration or Expulsion of Device; Malposition of Device

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A PAU. IT WAS REPORTED DURING THE INDEX PROCEDURE WHEN THE SECONDARY MECHANISM OF DEPLOYING THE COVERED SEAL WAS RELEASED IT APPEARED TO PULL THE FABRIC DOWN IN THE PROXIMAL SEAL ZONE. MIGRATION WAS NOTED ON THE SIDE THAT THE TIP CAPTURE MECHANISM CAUGHT ON. THE PROXIMAL SEAL ZONE WAS NOT COMPROMISED SO NO FURTHER ACTION TAKEN. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS DEPLOYMENT TECHNIQUE AND THE DEPLOYMENT WAS COMPLETED IN A FLUID MOTION INSTEAD OF TWIST AND THEN PULL WITH THE QUICKER METHOD CAUSING THE DISTURBANCE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8361191 ↗