Valiant Navion™ VNMC4040C175TU (UDI 00763000260897)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000260897), received between Jan 6, 2021 and Feb 23, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Leak/Splash” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION  INTO ZONES 4 AND 5 .  IT WAS REPORTED AN ENDOLEAK WAS NOTED. THE PATIENT WAS NOTED TO HAVE A TYPE IV ENDOLEAK AT AN OFFICE VISIT AND AT THE RECENT FOLLOW-UP A WORSENING ENDOLEAK DUE TO GRAFT COMPONENT SEPARATION THAT IS A TYPE III ENDOLEAK WAS CONFIRMED .  NO INTERVENTION HAS TAKEN PLACE AND THE EVENT IS CONTINUING.  THE SITE ASSESSED THE TYPE III ENDOLEAK AS HAVING A CAUSAL RELATIONSHIP TO THE STUDY DEVICE, NOT RELATED TO THE STUDY PROCEDURE OR DISSECTION UNDER STUDY.  THE MEDICAL MONITOR ASSESSED THE EVENT AS RELATED  TO THE STUDY DEVICE, NOT RELATED TO THE STUDY PROCEDURE OR DISSECTION UNDER STUDY.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 16428862 ↗
• InjuryJan 16, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 200M THORACIC AORTIC DISSECTION ON THE (B)(6) 2019. IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP APPROXIMATELY ONE YEAR POST THE INDEX PROCEDURE WHERE A FENESTRATION DISTAL TO THE ORIGINAL GRAFT, THAT WAS NOT COVERED AT THE INITIAL IMPLANT CAUSED A TYPE IA OR IB ENDOLEAK AND FILLING EXPANSION OF THE FALSE LUMEN. INTERVENTION WAS PERFORMED AND TWO STENT GRAFTS VNMC4040C175TU AND VNMC4646C95TU WERE IMPLANTED FROM THE MID OF PREVIOUSLY PLACED VALIANT NAVION ALL THE WAY TO THE* CELIAC (COVERING THE FENESTRATION AND NOW ENTIRE LENGTH OF THE THORACIC AORTA). IT WAS REPORTED THAT FOLLOW UP CT ONE MONTH POST THE INTERVENTION SHOWED AN UNCHANGED TYPE IA ENDOLEAK + AORTIC ENLARGEMENT TO 53M. FOLLOW UP CT ONE YEAR LATER SHOWED UNCHANGED TYPE IA ENDOLEAK + AORTIC ENLARGEMENT WITH A SIGNIFICANT INCREASE FROM 53MM TO 81M. A 2ND AAA REPAIR FOR RECURRENT ENDOLEAK AND AORTIC ENLARGEMENT WAS COMPLETED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY AND A FENESTRATION DISTAL TO THE ORIGINAL GRAFT, THAT WAS NOT COVERED AT THE INITIAL IMPLANT CAUSED THE ENDOLEAK AND FILLING EXPANSION OF THE FALSE LUMEN. NO

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

  MAUDE report 16173165 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED AS PART OF A DISSECT-N STUDY FOR THE TREATMENT OF A CHRONIC TYPE B AORTIC DISSECTION WITH DEGENERATIVE THORACOABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED FROM A CORELAB REVIEW OF A CT WITH AND WITHOUT CONTRAST CARRIED OUT APPROXIMATELY 13 MONTHS POST IMPLANT THAT THERE WAS A PRESENCE OF AORTIC ENLARGEMENT DISTAL TO THE ENDOGRAFT +27. 4MM. THERE IS INCREASING CALIBER OF THORACIC AORTA ALONG DISTAL ASPECT OF ENDOGRAFT WITHIN THE UPPER ABDOMINAL AORTA. THE MAXIMAL MEASURE IS 81MM, PREVIOUSLY 53MM. THERE WAS NO ENDOLEAKS, MIGRATION OR FALSE LUMEN PERFUSION NOTED. APPROXIMATELY 9 MONTHS LATER THE PATIENT UNDERWENT OPEN REPAIR AS TREATMENT FOR THE KNOWN AORTIC ENLARGEMENT. DURING THE PROCEDURE , THE PATIENT UNDERWENT LEFT FEMORAL CUTDOWN WITH SIDE GRAFTING TO THE LEFT COMMON FEMORAL ARTERY, EXTENT III THORACOABDOMINAL AORTIC ANEURYSM REPAIR USING 28 MM NON MEDTRONIC GRAFT VIA LEFT FEMORO-FEMORAL PARTIAL CARDIOPULMONARY BYPASS WAS PERFORMED ALSO. THIS RESOLVED THE EVENT. THE PATIENTS POST-OPERATIVE COURSE WAS UNREMARKABLE. THE SITE ASSESSED THE EVENT AS NOT RELATED TO DEVICE OR PROCEDURE BUT HAVING A CAUSAL DEFINITE RELATIONSHIP TO THE DISSECTION

  Patient problems: Aneurysm

  MAUDE report 15605060 ↗
• MalfunctionMay 4, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION WAS IMPLANTED DURING A PROCEDURE. IT WAS REPORTED DURING A FOLLOW UP CT, A TYPE III ENDOLEAK WAS FOUND. PER THE PHYSICIAN THE SUBTYPE IS NOT SPECIFIED. PER PHYSICIAN, TYPE III ENDOLEAK IS NOT RELATED TO THE DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14277130 ↗
• InjuryJan 6, 2021Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 105MM THORACIC AORTIC ANEURYSM. A CTA PERFORMED 3 DAYS LATER, INDICATED DISTAL MIGRATION OF THE PROXIMAL STENT GRAFT OF APPROXIMATELY 2.2 CM ALONG THE GREATER CURVATURE OF THE TRANSVERSE AORTA. A TYPE IA ENDOLEAK WAS NOTED ON REPEAT CTA. A SECONDARY PROCEDURE WAS PERFORMED A FURTHER 3 DAYS LATER AND THE PATIENT RECEIVED A PROXIMAL EXTENSION OF A 40 X 40 X 182 FREE FLOW DEVICE TO THE LEVEL OF THE LEFT COMMON CAROTID WITHOUT ANY ISSUE. THIS RESOLVED THE EVENT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 11122749 ↗