Valiant Navion™ VNMC3737C223TU (UDI 00763000260866)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000260866), received between Jan 28, 2021 and Jun 7, 2024 — classified as 1 death, 2 injuries, 2 malfunctions.

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

• InjuryJun 7, 2024Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 43X59MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT WITH AND WITHOUT CONTRAST REVEALED ANEURYSMAL DILATION SLIGHTLY WITHIN THE AREA OF THE TEVAR IN THE DESCENDING THORACIC AORTA. OPACIFICATION OF BOTH FALSE AND TRUE LUMENS WAS OBSERVED IDENTIFIED BY THE PHYSICIAN TO BE A TYPE IA ENDOLEAK. INTERVENTION WAS PREFORMED, A VALIANT CAPTIVIA STENT GRAFT (B)(6) WAS PLACED PROXIMAL TO THE PREVIOUS TEVAR, JUST DISTAL TO THE LEFT CAROTID ARTERY. A FENESTRATION INTO THE LEFT SUBCLAVIAN ARTERY (LSCA) WAS CREATED, AND A NON-MDT 8MM COVERED STENT WAS DEPLOYED BETWEEN THEM. AN ADDITIONAL VALIANT CAPTIVIA STENT GRAFT (B)(6) WAS DEPLOYED, OVERLAPPING WITH THE DISTAL PORTION OF THE PREVIOUS TEVAR (VALIANT NAVION). ENDOVASCULAR FENESTRATION OF THE CHRONIC DISSECTION SEPTUM WAS ALSO PERFORMED. THE TREATMENT WAS COMPLETED, AND THE PHYSICIAN CONFIRMED GOOD APPOSITION AND CONTRAST FLOW, RESOLVING THE TYPE IA ENDOLEAK. THE CAUSE OF THE TYPE IA ENDOLEAK WAS NOT PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 19485632 ↗
• MalfunctionJul 27, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 71X85MM TAA . AN OPEN SURGICAL DEBRANCHING PROCEDURE WAS PERFORMED PRIOR TO THE IMPLANT OF THE NAVION STENT GRAFTS. THE VNMC3737C223TU WAS IMPLANTED PROXIMALLY AND VNMC4343C218TU IMPLANTED DISTALLY.  IT WAS REPORTED THROUGH THE SITE THAT CT IMAGING WAS PERFORMED OVER TWO YEARS LATER, WHERE CONTRAST WITHIN THE ANEURYSM SAC WAS NOTED AND A TYPE III ENDOLEAK WAS SEEN.  CORELAB HAVE REVIEWED THE SAME IMAGING AND NOTED THERE IS A IIIB ENDOLEAK IN THE STENT GRAFT VNMC3737C223TU (B)(6). NO FRACTURE WAS NOTED. STENT RING ENLARGEMENT  + 1.8MM  WAS NOTED ON RING 8 ON THE STENT GRAFT VNMC4343C218TU (B)(6).  NO STENT RING MIGRATION WAS NOTED. THE MAXIMUM DIAMETER MEASURED 81.1MM. AORTIC ENLARGEMENT + 10.6MM WAS OBSERVED. THIS IMAGING WAS COMPARED TO PREVIOUS IMAGING DATED FIVE MONTHS POST THE INDEX PROCEDURE. THE CAUSE COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm expansion; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17404421 ↗
• DeathJul 19, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THAT CORELAB REVIEW OF CT IMAGING DATED (B)(6) 2020 SHOWED A NEW TYPE IB ENDOLEAK IN VNMC3737C223TU ((B)(6)). THERE WAS NO FRACTURE, NO STENT RING ENLARGEMENT AND NO STENT RING MIGRATION OBSERVED. THE MAXIMUM AORTIC DIAMETER WAS 62.1MM. VNMF3737C97TU ((B)(6)) WAS NON-EVALUABLE FOR FRACTURE DUE TO DEVICE OVERLAPS AND A SIGNIFICANT AMOUNT OF CALCIFICATION. IT WAS REPORTED THE PATIENT EXPIRED APPROXIMATELY 1 MONTHS POST THE INDEX PROCEDURE DUE TO AN UNKNOWN CAUSE. THE CAUSE OF THE ENDOLEAK AND DEATH IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17349514 ↗
• MalfunctionMay 2, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATLEY 2 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT WITHOUT CONTRAST IDENTIFIED A TYPE IIIA ENDOLEAK. THE MAXIMUM AORTIC DIAMETER WAS NOTED AS 46MM. CORE LAB REVIEW OF THE IMAGING IDENTIFIED NEW AORTIC ENLARGEMENT ALONG THE ENDOGRAFT OF +5.8MM AND DISTAL TO THE ENDOGRAFT OF +5.5MM. THE CORE REVIEW OF THE IMAGING DID NOT IDENTIFY ANY ENDOLEAK. THE CAUSE OF THE ENDOLEAK WAS NOT PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16851672 ↗
• InjuryJan 28, 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 WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED THE PATIENT PRESENTED TO ED 2 MONTHS LATER, WITH COMPLAINTS OF CHEST PAIN. A CTA PERFORMED SHOWED AN ACUTE TYPE A AORTIC DISSECTION INVOLVING THE ASCENDING THORACIC AORTA. INTERVENTION WAS PERFORMED ON THE SAME DATE, AN ASCENDING AORTIC ARCH REPLACEMENT WITH HEMI ARCH USING A NON MDT GRAFT WAS COMPLETED. THE SITE ASSESSED THE EVENT AS POSSIBLY RELATED TO THE STUDY DEVICE AND NOT RELATED TO THE STUDY PROCEDURE. THE SPONSOR ASSESSED THE EVENT AS RELATED TO THE DEVICE AND NOT RELATED TO PROCEDURE. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Cardiac Tamponade; Pain; Vascular Dissection

  MAUDE report 11243705 ↗