Valiant Navion™ VNMF3131C174TU (UDI 00763000100605)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000100605), received between May 26, 2020 and Jun 30, 2023 — classified as 3 deaths, 2 injuries, 3 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.

• DeathJun 30, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR PROCEDURE OF A DISSECTION AND ULCER. IT WAS REPORTED 2 DAYS POST THE INDEX PROCEDURE, FOLLOW-UP CT SHOWED A SUSPECTED TYPE IA ENDOLEAK. IT WAS NOTED THAT 11MM OF OUTPOUCHING OF CONTRAST NEAR THE PROXIMAL END OF THE ENDOGRAFT HAD INCREASED IN SIZE AND IS IN THE SAME LOCATION AS PREVIOUSLY DESCRIBED PAU. INTERVENTION WAS PERFORMED AND A NON-MDT STENT GRAFT WAS IMPLANTED. A PROFUNDA PATCH ANGIOPLASTY WAS ALSO PERFORMED IN THE LEFT FEMORAL ARTERY. THE PATIENT EXPIRED APPROXIMATELY 3 WEEKS POST THE INTERVENTION. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK AND DEATH COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 17237728 ↗
• DeathJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A RUPTURED THORACIC ANEURYSMAL TYPE B AORTIC DISSECTION ON (B)(6) 2019. IT WAS NOTED THE PATIENT HAD A PREVIOUS REPAIR 7 YEARS PREVIOUS. IT WAS REPORTED DURING THE INDEX PROCEDURE, AN EMERGENT SALVAGE REPAIR WITH 2 NAVION GRAFTS WERE IMPLANTED. THE EXISTING GRAFTS WERE NOTED TO BE TORTUOUS WHICH MADE THE PROCESS DIFFICULT. THE PATIENT WAS NOTED TO BE HEMODYNAMICALLY STABLE AFTER COMPLETION, HOWEVER THE PATIENT SUFFERED ANEURYSM RUPTURE AND SUFFERED A PEA ARREST IN ICU SOON AFTER THE TEVAR WAS COMPLETED & EXPIRED. PER THE PHYSICIAN THE CAUSE OF THE RUPTURE AND DEATH ARE UNDETERMINED.

  Patient problems: Cardiac Arrest; Rupture

  MAUDE report 16223017 ↗
• MalfunctionDec 5, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING FROM ON (B)(6) 2021 IDENTIFIED A TYPE IA ENDOLEAK. NO STENT FRACTURE OR STENT RING ENLARGEMENT WAS OBSERVED. THE IMAGING WAS NOTED AS N/A FOR STENT RING MIGRATION AND AORTIC ENLARGEMENT. THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. IT WAS NOTED THE PHYSICIAN DID NOT REPORT ANY CONCERNS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15914071 ↗
• MalfunctionAug 31, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM . IT WAS REPORTED CORE LAB REVIEW OF CT IMAGES IDENTIFIED A TYPE LL ENDOLEAK. NO STENT RING ENLARGEMENT, STENT FRACTURE, OR STENT RING DISPLACEMENT WERE OBSERVED. THE PHYSICIAN HAS CONFIRMED THAT THE TYPE II ENDOLEAK LOOKS LIKELY FROM THE INTERCOSTALS OR BRONCHIAL ARTERIES. THE PHYSICIAN ALSO REPORTED THAT THE DISTAL SEAL IS TENUOUS, AND THE ANEURYSM DIAMETER IS ENLARGING. NO CAUSE OF THE LOSS OF SEAL WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15326300 ↗
• InjuryJun 21, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION.  IT WAS REPORTED APPROXIMATELY 10 MONTHS POST THE INDEX PROCEDURE FALSE LUMEN PERFUSION TO THE PRIMARY ENTRY TEAR WAS DIAGNOSED. THE CT ALSO SHOWED ENLARGEMENT OF THE MID DESCENDING THORACIC AORTA AND AT THE DIAPHRAGMATIC HIATUS. ON THE SAME DATE THE PATIENT HAD A LEFT CAROTID SUBCLAVIAN BYPASS AND THE NEXT DAY HAD A STENT GRAFT IMPLANTED AS A PROXIMAL EXTENSION.  THE EVENT RESOLVED. THE PATIENT REQUIRED HOSPITALIZATION.  THE SITE ASSESSED THE EVENT AS NOT RELATED TO THE DEVICE OR PROCEDURE AND HAVING A CAUSAL RELATIONSHIP TO THE DISSECTION UNDER STUDY . THE MEDICAL MONITOR ASSESSED THE EVENT AS RELATED TO THE STUDY DEVICE, NOT RELATED TO STUDY PROCEDURE AND RELATED TO THE DISSECTION UNDER STUDY.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 14754307 ↗
• MalfunctionMar 15, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  TWO VALIANT NAVION STENTS GRAFT WERE IMPLANTED DURING AN ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM ON (B)(6) 2019. 4 ADDITIONAL NON-MEDTRONIC (GORE) STENT GRAFTS ARE IMPLANTED DISTALLY TO THE NAVION GRAFTS AND ENDOANCHORS ARE ALSO IMPLANTED. IT WAS REPORTED ON (B)(6) 2019 FOLLOW UP CT IDENTIFIED AN ENDOLEAK OF UNDETERMINED TYPE. FURTHER FOLLOW-UP CT ON (B)(6) 2019 DEMONSTRATED NO ENDOLEAK. STABLE SIZE OF THE ANEURYSM SAC WAS ALSO NOTED. NO ADDITIONAL CLINICAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Stenosis

  MAUDE report 13769866 ↗
• DeathApr 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT THE PATIENT DIED APPROX. 1 MONTH POST PROCEDURE. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS INFECTION. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT EXPIRED.

  Patient problems: Unspecified Infection

  MAUDE report 11635155 ↗
• InjuryMay 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED A MONTH LATER VIA TECHNICAL SERVICES THAT THE DEVICE DETAILS WERE SOUGHT BY A HEALTH CARE PROFESSIONAL BECAUSE IT WAS REPORTED THAT THE DEVICE MAY BE INFECTED AND AN EXTRACTION MAY BE NECESSARY. FOLLOWING THIS IT WAS CONFIRMED THAT AT THE TIME OF AN EMERGENCY TREATMENT, THE PATIENT HAD AN UNDERLYING INFECTION, THIS WAS NOT A RESULT OF THE DEVICE OR IMPLANT ITSELF. IT WAS REPORTED THAT THE INFECTION DID NOT IMPROVE SO THE PATIENT WAS REFERRED AND THE DEVICE WAS EXPLANTED, THE PATIENT IS SINCE RECOVERING. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT IS BEING MONITORED.

  Patient problems: Unspecified Infection

  MAUDE report 10086000 ↗