Valiant Navion™ VNMC4646C175TU (UDI 00763000260972)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000260972), received between May 10, 2021 and Apr 25, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 25, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 59MM TAA . THE PATIENT HAD A FROZEN ELEPHANT TRUNK PLACED WITH FENESTRATIONS FOR THE LEFT CAROTID AND LEFT SUBCLAVIAN ARTERY. AT THE TIME OF THE INDEX PROCEDURE, THE PATIENT WAS NOTED TO HAVE A HIGH THORACIC AORTIC ANEURYSM AT THE PROXIMAL DESCENDING AORTA. DURING THE PROCEDURE THE PHYSICIANS  WERE ABLE TO LAND THE VALIANT NAVION STENT GRAFT JUST DISTAL TO THE LEFT SUBCLAVIAN STENT WITHOUT ENCROACHING ON THE STENT.  IT WAS REPORTED WHEN THE PATIENT PRESENTED FOR FOLLOW-UP , IT WAS NOTED THERE APPEARED TO  BE PROBABLY A TYPE III ENDOLEAK THAT HAD DECREASED IN SIZE ON REPEAT IMAGING AND THE ANEURYSM HAD NOT CONTINUED TO GROW. THE PATIENT WAS HAVING SOME INTERMITTENT BACK PAIN BEHIND THE LEFT SHOULDER BLADE THAT SEEMS TO COME AND GO BUT WAS NOT INCREASING IN FREQUENCY. HOWEVER , UPON REVIEW FURTHER IMAGING SHOWS THAT THE ENDOLEAK WAS PERSISTENT. THE PHYSICIAN BELIEVED THE ANEURYSM WAS STABLE FROM THE PREOPERATIVE REPAIR WITH NO INCREASE IN SIZE.  IT WAS THOUGHT TO MEASURE ABOUT 5.2 CM WHICH WAS UNCHANGED COMPARED TO PREVIOUS IMAGING. IT WAS SAID THE PATIENT ATTENDED ANOTHER FACILITY WHERE THE PLAN WAS FOR T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16805518 ↗
• MalfunctionMar 24, 2022Leak/Splash; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Migration or Expulsion of Device; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. IT WAS REPORTED ON AN UNKNOWN DATE THE FOLLOWING YEAR THAT THE PHYSICIAN HAS INDICATED THAT THIS PATIENT IS BEING MONITORED AND WILL MOST LIKELY NEED A RE-OPERATION. A RE-OPERATION HAS NOT OCCURRED YET BUT THE PHYSICIAN BELIEVES THE PATIENT MAY NEED ONE. THE PHYSICIAN DID NOT SPECIFY WHY THE PATIENT WOULD NEED ANOTHER OPERATION. THE PATIENT CONTACTED MEDTRONIC'S PATIENT'S SERVICES AND STATED THAT WITHIN THE EVENT MONTH, THE IMPLANTED STENTS WERE FOUND TO HAVE MIGRATED AND CAUSED ANOTHER ANEURYSM. THE PATIENT INFORMED THAT ACCORDING TO THE PHYSICIAN, THE NEW ANEURYSM CANNOT BE REPAIRED AS THERE IS A RISK TO THE PATIENT'S SPINE.

  Patient problems: Aneurysm

  MAUDE report 13888075 ↗
• InjuryMay 10, 2021Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 44-450MM THORACIC DISSECTION. APPROXIMATELY 9 MONTHS POST INDEX PROCEDURE, THE PATIENT RETURNED FOR A FOLLOW UP WHERE A POSSIBLE TYPE IIIA ENDOLEAK WAS OBSERVED, NO CAUSE OF THE EVENT HAS BEEN PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 11797076 ↗