Valiant Navion™ VNMF3434C229TURecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000100650), received between Feb 14, 2019 and Apr 20, 2023 — classified as 4 injuries, 1 malfunction.

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.

• InjuryApr 20, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 55MM  TAA . IT WAS REPORTED ON THE DATE OF THE CT A TYPE IIIB ENDOLEAK WAS FOUND DURING ROUTINE NAVION RECALL MONITORING. THE ENDOLEAK WAS THEN CONFIRMED DURING ANGIOGRAM. A NON MDT (TERUMO) STENT GRAFT WAS IMPLANTED TO RELINE APPROXIMATELY 5 WEEKS LATER. PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS A NAVION FAILURE.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 16775833 ↗
• InjuryOct 17, 2022Leak/Splash; Migration or Expulsion of Device; Leak/Splash; Migration or Expulsion of Device

  A VALIANT NAVION THORACIC STENT GRAFT WAS IMPLANTED FOR THE TREATMENT FOR A THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT A CT PERFORMED APPROXIMATELY 6 MONTHS POST INDEX PROCEDURE IDENTIFIED A TYPE IA ENDOLEAK. A SECONDARY PROCEDURE WAS PERFORMED APPROXIMATELY 7 MONTHS POST INDEX PROCEDURE WITH THE INDICATION OF ANEURYSM GROWTH. IT WAS REPORTED ON EXAMINATION OF THE CT (B)(6) 2019) IT ALSO APPEARED THAT THE ORIGINAL ENDOGRAFT HAD MIGRATED SOMEWHAT FROM THE LEFT SUBCLAVIAN ARTERY. DURING THE INTERVENTION, THE TYPE IA ENDOLEAK WAS CONFIRMED ON AORTOGRAM. A 34MM VALIANT NAVION STENT GRAFT WAS IMPLANTED. A COMPLETION ANGIOGRAM DEMONSTRATED RESIDUAL LEAK INTO THE PROXIMAL DESCENDING THORACIC AORTA. BALLOONING WITH A RELIANT WAS ATTEMPTED HOWEVER THIS RESULTED IN SOME DOWNWARD DISPLACEMENT OF THE GRAFT. THE PHYSICIAN ELECTED TO IMPLANT A SECOND COMPONENT (34 MM IN DIAMETER UNIFORMLY AND 10 CM IN LENGTH). THIS WAS PASSED OVER A NON MDT WIRE AND DEPLOYED. THERE WAS STILL A SLIGHT BLUSH OF CONTRAST INTO THE THORACIC AORTA ALONG THE INFERIOR BORDER BUT THE PREVIOUS LEAK ALONG THE UPPER BORDER WAS ABSENT. CONSIDERING THIS A SATISFACTORY REVISION THE PHYSICIAN ENDED THE PROCEDURE. AS PER THE

  Patient problems: Chest Pain; Insufficient Information

  MAUDE report 15615116 ↗
• InjuryJan 6, 2022Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THE PATIENT RETURNED FOR A FOLLOW-UP CT WHERE IT WAS DISCOVERED THE PROXIMAL STENT (VNMF3434C229TU) HAD A TYPE IA ENDOLEAK AND STENT RING ENLARGEMENT. NO CAUSE OF THE TYPE IA ENDOLEAK OR STENT RING ENLARGEMENT WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13174094 ↗
• InjuryJan 20, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF TYPE B AORTIC DISSECTION ON THE (B)(6) 2019. IT WAS REPORTED THAT WHEN THE PATIENT RETURNED FOR ROUTINE FOLLOW UP ON THE (B)(6) 2019, A CT WHICH WAS PREFORMED SIX DAYS EARLIER ON THE (B)(6) 2019 SHOWED THE PATIENT HAD A TYPE A RETROGRADE DISSECTION. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC OF THE DISSECTION. THE PATIENT WAS BROUGHT TO OR THAT DAY WHERE THE DISSECTION WAS TREATED AND RESOLVED.

  Patient problems: Intimal Dissection

  MAUDE report 9607052 ↗
• MalfunctionFeb 14, 2019Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem; Deformation Due to Compressive Stress; Activation, Positioning or Separation Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF 200MM DISSECTION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE VNMF3434C229TU WAS ADVANCED OVER A LUNDERQUIST WIRE WITH MODERATE FORCE TO ADVANCE THE DEVICE THROUGH TORTUOUS ANATOMY. IT WAS REPORTED THAT ONCE THE GRAFT WAS IN POSITION DEPLOYMENT WAS ATTEMPTED BUT THE SCREW GEAR WOULD NOT TURN. IT WAS REPORTED THAT THE TRIGGER WAS THEN ATTEMPTED TO BE PULLED TO TRY DEPLOYING AGAIN. THE DEVICE WAS THEN REMOVED AND A KINK WAS NOTED ON THE GRAFT COVER. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED BUT IT WAS NOTED THAT THERE WAS EXTREMELY TORTUROUS ANATOMY. IT WAS ALSO REPORTED THAT WHEN ATTEMPTING TO IMPLANT VNMF3434C174TU THE STENT GRAFT DEPLOYED SUCCESSFULLY BUT WHEN THE DELIVERY SYSTEM AND WIRE WAS RELAXED TO RELEASE THE TIP CAPTURE THE TIP CAPTURE ONLY RELEASED HALFWAY. IT WAS ATTEMPTED TO PUSH SLIGHTLY FORWARD AND TRY TO RELEASE THE TIP CAPTURE BUT AGAIN IT DIDN¿T FULLY RELEASE AGAIN. THE BACK BLUE HANDLE WAS THEN SEPARATED AND THE TIP CAPTURE WAS MANUALLY RELEASED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8338908 ↗