Valiant Navion™ VNMC4343C218TU (UDI 00763000101152)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000101152), received between Jun 16, 2021 and Jul 18, 2024 — classified as 1 death, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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.

• MalfunctionJul 18, 2024Migration or Expulsion of Device; Migration or Expulsion of Device

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. THE STENT GRAFTS WERE PLACED IN ZONES 2 AND 3, WITH NO DEVICE DEFICIENCIES OBSERVED. IT WAS REPORTED APPROX.. 3 YEARS POST INDEX PROCEDURE, THAT A CT SCAN REVEALED MIGRATION. 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 19769603 ↗
• MalfunctionJul 11, 2024Leak/Splash; Migration or Expulsion of Device; Detachment of Device or Device Component; Leak/Splash; Migration or Expulsion of Device; Detachment of Device or Device Component

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED ON THE 23 MONTHS LATER, A CT WITHOUT CONTRAST WAS PERFORMED. THE SITE IDENTIFIED A IB ENDOLEAK. NO FALSE LUMEN PERFUSION OR MIGRATION WAS NOTED. THE MAXIMUM AORTIC DIAMETER WAS 52MM. NO STENT GRAFT INDUCED NEW ENTRY TEAR OR DISSECTION EXTENSION WAS NOTED. CORELAB REVIEWED THE SAME IMAGING, NO ENDOLEAK OR STENT RING ENLARGEMENT WAS NOTED. NE FOR FRACTURE AND STENT RING MIGRATION DUE TO SLICE THICKNESS. AORTIC ENLARGEMENT PROXIMAL TO THE ENDOGRAFT OF +17.7MM WAS OBSERVED. A IB ENDOLEAK WAS NOTED ON A CT WITH CONTRAST DATED NINE MONTHS LATER. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 19719016 ↗
• InjuryAug 4, 2022Leak/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 FOR THE ENDOVASCULAR TREATMENT OF THORACIC AORTIC ANEURYSM. AN ADDITIONAL VALIANT STENT GRAFT (46X46X150) WAS IMPLANTED APPROXIMATELY 1 YEAR LATER TO TREAT A TYPE IB ENDOLEAK IN VNMC4343C218TY (B)(4) WHICH WAS CONFIRMED AS RESOLVED. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THE PATIENT RETURNED FOR A FOLLOW-UP CT WHERE A TYPE IB ENDOLEAK WAS OBSERVED AND THE ANEURYSM SAC MEASURED 76MM. THE PHYSICIAN IS UNABLE TO DETERMINE WHICH DEVICE CONTAINS THE ENDOLEAK. NO CAUSE OF THE EVENT AS PER THE PHYSICIAN WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 15162063 ↗
• DeathJun 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 57MM THORACIC AORTIC ANEURYSM.  IT WAS REPORTED THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 1 YEAR POST THE INDEX PROCEDURE. WORSENING ANEURYSMAL DILATION OF THE DISSECTED AORTA IN GREATEST TRANSVERSE AT THE LEVEL OF THE DIAPHRAGM WAS OBSERVED. A 63MM AAA RUPTURE HAD OCCURRED. IT WAS REPORTED THE PATIENT EXPIRED ON THE DAY THEY PRESENTED.  AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS DUE TO RUPTURE OF THE ANEURYSM WHICH RESULTED IN CARDIAC ARREST. THE CUASE OF THE AAA RUPTURE WAS DUE IN PART TO WORSENING DILATION AT THE LEVEL OF THE DIAPHRAGM. NO ENDOLEAK WAS NOTED AFTER THE NAVION GRAFT WAS IMPLANTED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Aneurysm; Myocardial Infarction; Rupture

  MAUDE report 14683920 ↗
• InjuryJun 16, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT APPROXIMATELY ONE YEAR LATER, A CT WAS PERFORMED, WHERE A DISTAL TYPE ENDOLEAK 1 WAS OBSERVED. THE EVENT WAS TREATED WITH A VALIANT STENT GRAFT APPROXIMATELY 4 MONTHS LATER. THE ENDOLEAK WAS RESOLVED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS PATIENT'S ANATOMY. IT WAS STATED THAT THE DISTAL THORACIC AORTA HAD DILATED UP LARGER THAN THE CURRENT STENT GRAFT. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12009506 ↗