Valiant Navion™ VNMC4343C175TU (UDI 00763000101145)Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00763000101145), received between Apr 20, 2021 and Feb 6, 2024 — classified as 3 deaths, 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (9 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2024Fracture; Leak/Splash; Detachment of Device or Device Component; Fracture; Leak/Splash; Detachment of Device or Device Component

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. THE PATIENT HAD 2 VALAINT CAPTIVA STENT GRAFTS PREVIOUSLY IMPLANTED PROXIMAL TO THE NAVION GRAFT6 YEARS PREVIOUS. IT WAS REPORTED APPROXIMATELY 4 YEARS POST THE NAVION IMPLANT, FOLLOW UP CT SHOWED THE DISTAL NAVION GRAFT IS NO LONGER INTACT. THE STENT IS FRACTURED AND NO LONGER APPEARS TO BE ATTACHED TO ANYTHING. THE DISTAL SEAL IS GONE WITH A SUSPECTED TYPE IB ENDOLEAK. ANEURYSM EXPANSION WAS OBSERVED. PER THE PHYSICIAN THE CAUSE OF THE FRACTURE AND ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PAT IENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18651483 ↗
• DeathAug 22, 2023Leak/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 AN UNKNOWN ENDOVASCULAR TREATMENT. IT WAS REPORTED THROUGH TECHNICAL SERVICES BY THE PATIENT THAT THE PATIENT HAS NOT FELT BETTER SINCE IMPLANT AND THAT A FOLLOW-UP CT PERFORMED SHOWED THE GRAFT IS LEAKING. PER THE PHYSICIAN, THE PATIENT RETURNED FOR FOLLOW UP ON (B)(6) 2021. IT WAS REPORTED THERE WAS NO ENDOLEAK OBSERVED BUT THAT THE PATIENTS AORTA HAD DEGENERATED DISTAL TO THE IMPLANTED STENT GRAFTS. DUE TO THE PATIENTS AGE AND MEDICAL HISTORY FURTHER TREATMENT HAS NOT BEEN PERFORMED. CORE LAB REVIEW OF CT IMAGING FROM APPROXIMATLEY 3 YEARS POST THE INDEX PROCEDURE IDENTIFIED A TYPE IB ENDOLEAK ON VNMC4343C175TU (V29556853). THE MAX AORTIC DIAMETER WAS NOTED AS 66.2MM WITH NEW AORTIC ENLARGEMENT OF +5.6MM OBSERVED COMPARED TO IMAGING FROM (B)(6) 2020. NO STENT FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED. THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 17593941 ↗
• DeathNov 18, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION. IT WAS REPORTED ONE MONTH POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED A TYPE IB ENDOLEAK. IT WAS REPORTED THE PATIENT EXPIRED ONE MONTH POST THE INDEX PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK AND DEATH ARE UNDETERMINED.

  Patient problems: Insufficient Information

  MAUDE report 15824302 ↗
• InjuryNov 15, 2022Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN ENDOVASCULAR AORTIC REPAIR APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE. THE NAVION GRAFT WAS IMPLANTED DISTALLY TO THE EXISTING GRAFTS. IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED A TYPE IA ENDOLEAK. CORE LAB REVIEW OF CT IMAGING FROM (B)(6) 2022 FOR THE NAVION STENT GRAFT IDENTIFIED NEW STENT RING ENLARGEMENT OF +1.4MM. NO ENDOLEAK, STENT FRACTURE, STENT RING MIGRATION OR AORTIC ENLARGEMENT WERE IDENTIFIED. A TYPE IA ENDOLEAK WAS OBSERVED ON A NON NAVION DEVICE. IT WAS NOTED THE NON NAVION DEVICE WAS NOT A BIFURCATED DEVICE. A PLANNED INTERVENTION ONE MONTH POST IMAGING (TEVAR REPAIR FOR THE TYPE IA ENDOLEAK WITH LASER FENESTRATION AND LSA STENTING) WAS ABORTED DUE TO RESISTANCE OF STENT GRAFT THROUGH THE ILIAC VESSELS BILATERALLY. A LEFT AND RIGHT OCCLUSION OCCURRED LEADING TO EMERGENT EXPLORATORY EMBOLECTOMY, PATCH ANGIOPLASTY AND ENDARTERECTOMY. THE CAUSE OF THE TYPE IA ENDOLEAK AND STENT RING ENLARGEMENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATI

  Patient problems: Embolism/Embolus; Obstruction/Occlusion

  MAUDE report 15795946 ↗
• InjuryMar 29, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED THE PATIENT PRESENTED TO HOSPITAL FOR AN UNKNOWN REASON APPROXIMATELY 3.5 YEARS POST THE INDEX PROCEDURE AND A TYPE IB ENDOLEAK WAS OBSERVED BELOW THE LARGER DISTAL GRAFT (VNMC4343C175TU). IT WAS REPORTED THE PATIENT RECEIVED TREATMENT ON (B)(6) 2022. NO CAUSE FOR THE TYPE IB ENDOLEAK AS PER THE PHYSICIAN WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 13937714 ↗
• InjuryFeb 16, 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 DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM. TWO FURTHER VALIANT NAVION STENT GRAFTS WERE IMPLANTED 3 MONTHS LATER. IT WAS REPORTED THAT THE PATIENT RETURNED FOR A FOLLOW-UP CT A FURTHER 5 MONTHS LATER, A TYPE IA ENDOLEAK WAS OBSERVED. ANOTHER CT WAS TAKEN AND THE TYPE IA ENDOLEAK WAS STILL PRESENT.  NO CAUSE AS PER THE PHYSICIAN WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONIOTRED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13541693 ↗
• InjuryNov 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT CAPTIVIA AND VALIANT NAVION STENT GRAFT SYSTEMS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSMN. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH AORTIC RUPTURE SYMPTOMS. LOCATION OF THE RUPTURE WAS UNKNOWN BUT SUSPECTED TO BE DISTAL TO THE GRAFT. INTERVENTION WAS CARRIED OUT AND THE THORACIC AORTA WAS RELINED AND EXTENDED DISTALLY WITH A NON-MDT GRAFT. NO CAUSE OF THE EVENT WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Rupture

  MAUDE report 12757653 ↗
• MalfunctionOct 12, 2021Leak/Splash; Material Deformation; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Material Deformation; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION WAS IMPLANTED IN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED ON AN UNKNOWN DATE FOLLOW UP CT DEMONSTRATED AN UNKNOWN TYPE ENDOLEAK. THE PHYSICIAN ADDITIONALLY EXPRESSED CONCERN THAT THE STENT MAY BE UNZIPPING. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK AND UNZIPPING IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12614458 ↗
• DeathSep 9, 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 A CT WAS PERFORMED APPROXIMATELY 20 MONTHS POST INDEX PROCEDURE, WHERE AN ENDOLEAK TYPE 1B WAS OBSERVED. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 12447260 ↗
• InjuryApr 20, 2021Leak/Splash; Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Migration or Expulsion of Device; Material Deformation; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC DISSECTION. IT WAS REPORTED THAT A NON-MDT STENT GRAFT WAS IMPLANTED ON AN UNKNOWN DATE BY A DIFFERENT PHYSICIAN FOR AN ADDITIONAL INTERVENTION. IT WAS REPORTED THAT THE CORE LAB REVIEW IDENTIFIED A STENT RING ENLARGEMENT OF THE DISTAL DEVICE WITH AN ENDOLEAK TYPE UNDETERMINED, BUT CONCERN FOR TYPE IIIB ENDOLEAK, ON CT IMAGES FROM 12M FOLLOW UP. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. IT WAS REPORTED THAT THE NON-MDT DEVICE THAT WAS IMPLANTED SOMETIME FOLLOWING THE INDEX PROCEDURE WAS SMALLER IN DIAMETER TO THE PREVIOUSLY IMPLANTED NAVION DEVICE WHICH MAY HAVE LED TO THE POSSIBLE TYPE IIIB ENDOLEAK. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information

  MAUDE report 11693131 ↗