Valiant Navion™ VNMC3737C223TU (UDI 00763000101077)Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 00763000101077), received between May 10, 2021 and Feb 24, 2025 — classified as 5 deaths, 7 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (11 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 24, 2025Leak/Splash; Leak/Splash

  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY, APPROXIMATELY 4 YEARS AND 3-MONTH POST INDEX PROCEDURE, AND UNDERWENT A COMPUTED TOMOGRAPHY SCAN. AN UNKNOWN ENDOLEAK WAS IDENTIFIED IN VALIANT NAVION STENT GRAFT (S) IN THE THORACIC AORTA. THE 37 X 37 VALIANT NAVION WAS IMPLANTED PROXIMALLY WHILE THE 43 X 43 WAS IMPLANTED DISTALLY. THE PHYSICIAN DOES NOT KNOW THE SUBTYPE OF THE ENDOLEAK. INTERVENTION WAS PERFORMED APPROXIMATELY 5.5 WEEKS LATER WHERE THE NAVION STENTS WERE RELINED WITH A NON-MEDTRONIC STENT GRAFT. THE HEALTHCARE PROFESSIONAL ATTRIBUTED THE EVENT TO A LEAK IN THE NAVION DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 21446265 ↗
• DeathJan 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS  WERE IMPLANTED DURING AN EMERGENT TREATMENT OF A UNKNOWN LENGTH THORACIC AORTIC DISSECTION. AN 8MM DACRON FOR LEFT AND RIGHT CAROTID TO LEFT <(>&<)> RIGHT SUBCLAVIAN BYPASS WERE ALSO IMPLANTED. IT WAS REPORTED THAT THE PATIENT REMAINED IN CRITICAL CONDITION POST PROCEDURE AND EXPIRED 2 DAYS LATER. NO CAUSE OF DEATH  WAS PROVIDED. THERE WAS NO ADDITIONAL SEQUELAE REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 16239324 ↗
• MalfunctionJan 25, 2023Leak/Splash; Malposition of Device; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Malposition of Device; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED FOR THE TREATMENT OF AN UNKNOWN LENGTH DISSECTION. IT WAS REPORTED APPROXIMATELY 7 MONTHS POST THE INDEX PROCEDURE, CT IMAGING IDENTIFIED AN PATIENT HAD UNDETERMINED ENDOLEAK AND AORTIC ENLARGEMENT. NO CAUSE PROVIDED. NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16239263 ↗
• MalfunctionJan 23, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE INDEX PROCDURE, FOLLOW UP CT IDENTIFIED A TYPE I ENDOLEAK AND ANEURYSM EXPANSION. IT WAS NOTED DUE TO AGE AND OTHER COMORBIDITIES, THE ENDOLEAK IS INOPERABLE. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 16222930 ↗
• InjuryJan 16, 2023Leak/Splash; Detachment of Device or Device Component; Leak/Splash; Detachment of Device or Device Component

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA.  IT WAS REPORTED A CT PERFORMED NOTED AORTIC ENLARGEMENT FROM 48 TO 53MM. A TYPE III ENDOLEAK AND TYPE IA ENDOLEAK WERE ALSO NOTED. A TEVAR WAS PERFORMED AS TREATMENT WITH A SUBCLAVIAN BYPASS. 3 STENTS WERE PLACED. A MONTH LATER, A UNDETERMINED ENDOLEAK (CHRONIC) WAS CONFIRMED.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 16173103 ↗
• MalfunctionJan 12, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A IMH. IT WAS REPORTED APPROXIMATELY 29 MONTHS AND 35 MONTHS POST THE INDEX PROCEDURE FU CT NOTED A TYPE II AND TYPE IIIA ENDOLEAKS. THE TYPE II IS LOCATED AT THE LEVEL OF THE AORTIC ARCH AND THE TYPE IIIA NOTED AT THE LEVEL OF THE MID ASCENDING THORACIC AORTA. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16147973 ↗
• InjuryAug 23, 2022Adverse 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 AN ENDOVASCULAR TREATMENT.  IT WAS REPORTED THAT A CT WAS PERFORMED IN A UNKNOWN DATE, WHERE AN AORTIC ENLARGEMENT WAS OBSERVED. THE EVENT WAS TREATED WITH A PLACEMENT OF MORE DISTAL NON MDT GRAFT AT THE LEVEL OF THE LEFT SUBCLAVIAN ARTERY AND PLACEMENT OF A MORE DISTAL 44X44X150 MM GRAFT UP TO THE LEVEL OF THE CELIAC TRUNK  AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PROXIMAL DILATION OF THORACIC AORTA AT THE LEVEL OF THE SUBCLAVIAN. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: Aneurysm

  MAUDE report 15274928 ↗
• InjuryAug 5, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE.  IT WAS REPORTED BY THE PATIENT VIA MEDWATCH (MW5110837) THAT THE STENT HAS FAILED CAUSED BY A TYPE III ENDOLEAK WHICH HAS RESULTED IN AORTIC ENLARGEMENT WHICH REQUIRED URGENT SURGERY. POST INTERVENTION THE PATIENT HAS REPORTED THAT THE AORTA REMAINS ENLARGED TO A LIFE THREATENING SIZE.  NO CAUSE OF THE ENDOLEAK OR GRAFT FAILURE HAS BEEN PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 15173446 ↗
• DeathJun 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO (2) VALIANT NAVION STENT GRAFTS WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A SACCULAR ANEURYSM OF AN UNKNOWN SIZE. THE PATIENT ALSO HAD AN NON-MEDTRONIC VASCULAR PLUG IMPLANTED DISTALLY TO VALIANT NAVION. IT WAS REPORTED THE PATIENT EXPIRED ON THE DATE OF THE INDEX PROCEDURE DUE TO ANEURYSM RUPTURE.  THE CAUSE OF THE ANEURYSM RUPTURE WAS NOT PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Rupture

  MAUDE report 14712692 ↗
• InjuryMay 26, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN LENGTH DISSECTION.  IT WAS REPORTED APPROXIMATLEY 4 MONTHS POST THE INDEX PROCEDURE CT IDENTIFIED AN UNDETERMINED ENDOLEAK WAS OBSERVED. THE PATIENT RECIEVED TREATMENT WHERE 2 ADDITIONAL VALIANT NAVION DEVICES WERE PLACED IN THE PROXIMAL DESCENDING THORACIC AORTA TO DISTAL DESCENDING THORACIC AORTA.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 14512327 ↗
• DeathJan 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED APPROXIMATELY 15 MONTHS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WHERE A CT CARRIED OUT SHOWED LEFT CAROTID DISSECTION AND AORTIC DISSECTION. THE PATIENT BECAME UNRESPONSIVE AND EXPIRED IN THE EMERGENCY DEPARTMENT.  AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS AORTIC DISSECTION. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Vascular Dissection

  MAUDE report 13167222 ↗
• DeathNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WHERE A TYPE I ENDOLEAK WAS IDENTIFIED. INTERVENTION WAS COMPLETED WITH 2 ADDITIONAL VALIANT NAVION STENT GRAFT SYSTEMS IMPLANTED. APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURE POST A REPAIR PROCEDURE AND SUFFERED A CARDIAC ARREST AND EXPIRED. AS PER THEY PHYSICIAN THE CAUSE OF ENDOLEAK AND RUPTURE WAS ANATOMY RELATED. THE CAUSE OF DEATH WAS DUE TO CARDIAC ARREST AS A RESULT OF A RUPTURE. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDE AND THE PATIENT HAS EXPIRED.

  Patient problems: Cardiac Arrest; Rupture

  MAUDE report 12758083 ↗
• DeathNov 7, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WHERE A TYPE I ENDOLEAK WAS IDENTIFIED. INTERVENTION WAS COMPLETED WITH 2 ADDITIONAL VALIANT NAVION STENT GRAFT SYSTEMS IMPLANTED. APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH A RUPTURE POST A REPAIR PROCEDURE AND SUFFERED A CARDIAC ARREST AND EXPIRED. AS PER THEY PHYSICIAN THE CAUSE OF ENDOLEAK AND RUPTURE WAS ANATOMY RELATED. THE CAUSE OF DEATH WAS DUE TO CARDIAC ARREST AS A RESULT OF A RUPTURE.  NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDE AND THE PATIENT HAS EXPIRED.

  Patient problems: Cardiac Arrest; Rupture

  MAUDE report 12758074 ↗
• MalfunctionOct 12, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION.  IT WAS REPORTED THAT A TYPE 1A ENDOLEAK WAS OBSERVED DURING A FOLLOW UP CT ABOUT 2 YEARS LATER.  NO CAUSE WAS PROVIDED.  NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT IS WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12614841 ↗
• MalfunctionOct 4, 2021Fracture; Material Deformation; Fracture; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A  250MM THORACIC AORTIC DISSECTION. IT WAS REPORTED APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE POSSIBLE STENT FRACTURE/ENLARGEMENT WAS OBSERVED ON FOLLOW UP CT.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12568120 ↗
• InjuryAug 3, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED FOR A 300 MM THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT ON THE DATE THE PATIENT RETURNED FOR FOLLOW-UP (UNKNOWN DATE), A LEAK OF CONTRAST FROM GRAFT LOCATED IN THE MIDDLE OF THE VALIANT NAVION WAS OBSERVED. IT WAS STATED THAT APPROXIMATELY 30 MONTHS POST INDEX PROCEDURE, A RELINE OF THE STENT GRAFT WAS COMPLETED USING 3 VALIANT STENT GRAFT SYSTEM NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12266789 ↗
• MalfunctionJul 19, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN LENGTH THORACIC AORTIC DISSECTION. IT WAS REPORTED A CT PERFORMED 8 MONTHS LATER IDENTIFIED THE PRESENCE OF A TYPE IA ENDOLEAK. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12188425 ↗
• InjuryMay 10, 2021Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED 3 DAYS LATER, A CLOT WAS IDENTIFIED AT THE LIJ (LEFT INTERNAL JUGULAR) AND EXTENDING TO THE BRACHIOCEPHALIC. THE SPONSOR ASSESSED THE EVENT AS RELATED TO STUDY DEVICE, PROCEDURE & DISSECTION. IT WAS REPORTED THAT A RESIDUAL DISSECTION EXTENSION TO THE LEFT COMMON ILIAC ARTERY WAS ALSO DIAGNOSED 3 DAYS POST THE INDEX PROCEDURE. THE CLINICAL EVENTS COMMITTEE (CEC) ASSESSED THIS EVENT AS NOT RELATED TO THE STUDY DEVICE AND RELATED TO THE PROCEDURE. THIS EVENT IS CONTINUING. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 11795989 ↗