Valiant Navion™ VNMF4646C183TU (UDI 00763000100803)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00763000100803), received between Feb 17, 2023 and May 2, 2025 — classified as 2 deaths, 2 injuries.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 2, 2025Fracture; Leak/Splash; Adverse Event Without Identified Device or Use Problem; Fracture; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 59MM TAAA. THE 43X43X100 WAS IMPLANTED PROXIMALLY, 46X46X183 DISTALLY, BRIDGED WITH 46X46X183 STENT GRAFT. THE PATIENT WAS LOST TO FOLLOW-UP AND LATER PRESENTED TO A DIFFERENT FACILITY FOR AN UNRELATED INCIDENT AND A CT SCAN WAS PERFORMED . ON THE CT SCAN, THE TWO PHYSICIANS REVIEWING INITIALLY THOUGHT THAT THE DISTAL AND MIDDLE NAVION DEVICES HAD PULLED UP FROM THEIR INITIAL LANDING ZONES DUE TO ANEURYSM ENLARGEMENT BUT A STENT FRACTURE WAS ALSO SUGGESTED AS POSSIBLE CAUSE OF THE ISSUE. A PLAN WAS MADE TO RELINE THE DEVICE DOWN TO THE SMA AS THE CELIAC ARTERY WAS COMPLETELY STENOSED WITHOUT ANTEGRADE FLOW, THE STENOSIS WAS UNRELATED TO THE NAVION STENT GRAFTS. NO ISSUES WERE NOTED WITH THE OTHER STENT GRAFTS. DURING THE INTERVENTION PROCEDURE, A FRACTURE PIECE OF THE STENT COULD BE VISUALIZED WELL BELOW THE REMAINING FABRIC AND STENT BODY OF THE MOST DISTAL NAVION DEVICE. THE PHYSICIAN THEN SUSPECTED THAT THE DISTAL NAVION FRACTURED LEAVING BEHIND A PARTIAL STRUT IN THE INITIAL DISTAL LANDING ZONE, WITH ITS FABRIC AND REMAINING STRUTS PULLED UP TOWARDS THE AORTIC ARCH. THE VALIANT NAVION LOST DISTAL SEAL

  Patient problems: Insufficient Information

  MAUDE report 21949430 ↗
• DeathAug 14, 2023Leak/Splash; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM ON AN UNKNOWN DATE. 2 VALIANT CAPTIVIA STENT GRAFTS WERE ALSO IMPLANTED.  IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING ON (B)(6) 2018, ON (B)(6) 2019, ON (B)(6) 2020 AND ON (B)(6) 2021. THE CT REVIEW OF IMAGES FROM ON (B)(6) 2018 REVEALED A TYPE IA ENDOLEAK ON VNMF4646C183TU (B)(6).  IMAGES FROM ON (B)(6) 2019, REVEALED TYPE IA ENDOLEAK AND AORTIC ENLARGEMENT OF +13.6MM WITH APPARENT AORTIC RUPTURE. THE FOLLOWING OBSERVATIONS WERE ALSO MADE; ON (B)(6) 2019, REVEALED AORTIC ENLARGEMENT OF 11.4MM. ON (B)(6) 2019, CT IMAGES REVEALED 12 MM AORTIC ENLARGEMENT. ON (B)(6) 2019, IMAGING SHOWED AORTIC ENLARGEMENT 12 MM. ON (B)(6) 2019, IMAGES REVEALED 13.3 MM AORTIC ENLARGEMENT. ON (B)(6) 2019, REVEALED 14.8 MM AORTIC ENLARGEMENT. ON (B)(6) 2020, REVEALED STENT RING ENLARGEMENT (SRE) +1.5MM (NEW), RING 2; VNMF4646C183TU (B)(6) AND AORTIC ENLARGEMENT 17.6 MM. SRE IS IN THE FIRST SEALING STENT OF THE MOST PROXIMAL DEVICE (VNMF4646C183TU (B)(6). ON (B)(6) 2021, REVEALED TYPE IA ENDOLEAK (VNMF4646C183TU (B)(6), AND SRE 1.4MM ON RING 2 OF VNMF4646C183TU (B)(6) AND AORTIC ENLARGEMENT OF 23.3MM, SR

  Patient problems: Insufficient Information; Rupture

  MAUDE report 17539157 ↗
• InjuryMay 3, 2023Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED 3 DAYS POST THE INDEX PROCEDURE, THE PATIENT WAS COMPLAINING OF BACK PAIN. CT IDENTIFIED TYPE IA AND TYPE IB ENDOLEAKS NOTED AS MINOR ENDOLEAKS. INTERVENTION WAS COMPLETED WITH COILING OF THE FALSE LUMEN PERFORMED TO RESOLVE THE ENDOLEAKS. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAKS ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain

  MAUDE report 16858995 ↗
• DeathFeb 17, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT IT WAS REPORTED CT IMAGING TAKEN UNDER THREE YEARS LATER IDENTIFIED A TYPE IA ENDOLEAK ON THE STENT GRAFT WITH SN (B)(4). THE MAXIMUM AORTIC DIAMETER WAS 71.7MM. NO STENT RING ENLARGEMENT OR MIGRATION WERE NOTED.  NE FOR FRACTUES DUE TO DEVICE OVERLAPS.  THE PATIENT DIED UNDER A MONTH DUE TO AN UNKNOWN CAUSE. THERE IS NO DEATH CERTIFICATE AVAILABLE. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 16395078 ↗