Valiant Navion™ VNMF4646C103TURecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00763000100797), received between Aug 17, 2022 and Aug 17, 2022 — classified as 1 injury.

The most frequently reported specific device problem is “Fracture” (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 18, 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.

• InjuryAug 17, 2022Fracture; Leak/Splash; Fracture; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM . A VALIANT CAPTIVIA STENT GRAFT WAS IMPLANTED 17 MONTHS LATER. ON THE (B)(6) 2022,  THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH UNKNOWN SYMPTOMS, A CT WAS PERFORMED AND REVEALED AN ENDOLEAK  IN THE PROXIMAL DESCENDING AORTA WHERE 4 ENDOGRAFTS WERE PREVIOUSLY PLACED. THE PATIENT WAS BROUGHT TO OR WHERE A ANGIOGRAM IN OR REVEALED A TYPE III ENDOLEAK COMING FROM 2 OF THE MOST PROXIMAL STENT GRAFTS , A VALIANT NAVION VNMF4646C103TU <(>&<)> A VALIANT CAPTIVA VAMF4036C150TU. THE PHYSICIAN STATED AT THE TIME IT WAS EITHER A DISJUNCTION AND/OR STENT FRACTURE. THE EVENT WAS TREATED ON THE SAME DAY WITH 3 VALIANT CAPTIVIA IMPLANTED TO RELINE THE THORACIC AORTA. AS PER THE PHYSICIAN, CAUSE OF THE EVENT CANNOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 15238907 ↗