Valiant Navion™ VNMF3434C97TU (UDI 00763000260422)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000260422), received between Oct 22, 2020 and Oct 22, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Leak/Splash” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryOct 22, 2020Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 98M ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE FOLLOW UP IMAGING IDENTIFIED A TYPE IA ENDOLEAK. AS THERE WAS NO MORE PROXIMAL NECK FOR EXTENSION THE PHYSICIAN PERFORMED AN OFF LABEL REPAIR UTILIZING A THORACIC DEVICE ( VNMF3434C97TU V30001447) IN CONJUNCTION WITH A LEFT RENAL FENESTRATION AND A RIGHT RENAL AND SMA SNORKEL. AT THE END OF THE REPAIR A SLIGHT TYPE IA ENDOLEAK WAS STILL DEMONSTRATED. THE PHYSICIAN ELECTED TO END THE PROCEDURE. PER THE PHYSICIAN THE CAUSE OF THE TYPE IA ENDOLEAK WAS ANATOMY RELATED DUE TO DISEASE DEGENERATION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10717251 ↗