Valiant Navion™ VNMF4337C185TU (UDI 00763000100889)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000100889), received between Mar 20, 2019 and Dec 7, 2023 — classified as 4 deaths, 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (4 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 16, 2026.

Recalls naming this device

1. Feb 12, 2021Open, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• DeathDec 7, 2023Leak/Splash; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED A ON AN UNKNOWN DATE THAT A MID-GRAFT FABRIC ENDOLEAK WAS DETECTED, RESULTING IN A RUPTURE OF THE ANEURYSM. THE PATIENT SUBSEQUENTLY DIED ON AN UNKNOWN DATE. PER THE PHYSICIAN THE CAUSE OF THE TYPE IIIB ENDOLEAK THAT LED TO RUPTURE AND SUBSEQUENT DEATH WAS NOT PROVIDED . NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Hematoma; Hemorrhage/Blood Loss/Bleeding; Rupture

  MAUDE report 18281371 ↗
• DeathJul 15, 2022Fracture; Leak/Splash; Fracture; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 100MM THORACIC AORTIC ANEURYSM. ANOTHER VALIANT NAVION STENT GRAFT WAS IMPLANTED THE NEXT DAY.  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 11 MONTHS POST INDEX PROCEDURE WITH A THORACIC RUPTURE. THE PHYSICIAN STATED THE CT SHOWED A POSSIBLE TYPE III ENDOLEAK. THE PATIENT EXPIRED ON THE SAME DAY.  AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS AS A RESULT OF THE THORACIC RUPTURE. NO CAUSE OF THE ENDOLEAK HAS BEEN REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Rupture

  MAUDE report 15026136 ↗
• DeathMay 30, 2022Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. A VALIANT NAVION GRAFT WAS IMPLANTED 3 MONTHS LATER DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. A VALIANT CAPTIVIA WAS IMPLANTED 16 MONTHS LATER. THREE VALIANT NAVIONS WERE IMPLANTED AS PART OF A REINTERVENTION FOR PRIOR AORTIC REPAIR APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT WAS COMPLETED AFTER THE PATIENT BECAME UNWELL. A TYPE II ENDOLEAK AND MULTIPLE UNKNOWN ENDOLEAKS WERE OBSERVED. NEW ANEURYSMAL DEGENERATION OF THE TEVAR AT THE PROXIMAL PART WAS NOTED WHICH RESULTED IN AN ENDOLEAK REQUIRING PROXIMAL EXTENSION. DIFFERENTIAL DIAGNOSIS INCLUDED AORTIC RUPTURE VS. EMBOLIC INFARCT TO THE SPLEEN. IT WAS REPORTED THE PATIENT EXPIRED THE DAY AFTER THE CT. AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS DUE TO MULTIPLE CAUSES - INFARCTION, INFECTION AND AORTIC RUPTURE. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Embolism/Embolus; Insufficient Information; Rupture; Unspecified Infection

  MAUDE report 14539939 ↗
• InjuryJun 24, 2021Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN 85MM TAA. APPROX. 7 MONTHS POST PROCEDURE, IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY WITH BACK PAIN. CT SHOWED A DISTAL TYPE IB ENDOLEAK AND MIGRATION OF THE GRAFT INTO THE TAA SAC. INTERVENTION WAS PERFORMED THE SAME DAY WHERE A VAMF4040C100 WAS USED TO EXTEND ALONG WITH ENDOANCHORS TO RESOLVE THE EVENT. PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS PROGRESSIVE DILATION DUE TO PATIENT ANATOMY NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 12056678 ↗
• DeathMar 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 58MM THORACIC AORTIC ANEURYSM. A SENTRANT SHEATH WAS ALSO USED DURING THE PROCEDURE TO ACCESS THE RIGHT ILIAC ARTERY. THE PATIENT'S EXTERNAL ILIAC ARTERIES WERE 7 MM IN DIAMETER. NO TORTUOSITY OR CALCIFICATION OF THE ACCESS VESSELS WAS NOTED. IT WAS REPORTED THAT THE NAVION DEVICE WAS PLACED THROUGH THE SENTRANT SHEATH AND ADVANCED INTO THE PATIENT'S DESCENDING THORACIC AORTA UNDER FLUOROSCOPY. THE STENT GRAFT WAS DEPLOYED SUCCESSFULLY, AND THE DELIVERY SYSTEM WAS RETRACTED AND REMOVED FROM THE PATIENT VIA THE SHEATH. THEREAFTER, THE SENTRANT SHEATH WAS REMOVED FROM THE PATIENT. WHEN IT WAS COMPLETELY REMOVED FROM THE PATIENT, THE PATIENT'S TISSUE WAS OBSERVED TO BE CONNECTED TO THE SHEATH AND IT WAS REPORTED THAT THE PATIENT'S RIGHT ILIAC ARTERY WAS AVULSED. FOLLOWING THAT OBSERVATION, THE PATIENT'S BLOOD PRESSURE SIGNIFICANTLY DROPPED AND THEY EXPERIENCED UNCONTROLLED BLEEDING. THE PATIENT'S BLOOD PRESSURE WAS CONTROLLED BY REPAIRING THE ANATOMY, AND THEY WERE TRANSFERRED OUT OF THE OPERATING ROOM. THE PATIENT EXPIRED ONE DAY POST PROCEDURE. AS PER THE PHYSICIAN, THE CAUSE OF THE AV

  Patient problems: Blood Loss; Death

  MAUDE report 8435629 ↗