Valiant Navion™ VNMC3434C52TU (UDI 00763000101008)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00763000101008), received between Jun 26, 2020 and May 15, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult or Delayed Positioning” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT (VNMC3434C52TU) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. THE PATIENT HAD TWO EXISTING ANEURX AND A TALENT ABDOMINAL STENT GRAFTS IMPLANTED APPROXIMATELY 11 YEARS PRIOR, AND AN ADDITIONAL TALENT STENT GRAFT IMPLANTED APPROXIMATELY 10 YEARS PRIOR TO THE IMPLANTATION OF THE VALIANT NAVION. IT WAS REPORTED THAT SINCE THE IMPLANT OF THE VALIANT NAVION, THE PATIENT HAD PRESENTED TO ED WITH UTI AND POST POST-OP PAIN. IT WAS REPORTED CT IMAGING TAKEN 3YEARS AND 2 MONTHS AFTER THE VALIANT NAVION PROCEDURE, REVEALED POST-OPERATIVE CHANGES FROM TEVAR AND AORTOILIAC STENT GRAFT PLACEMENT. THE MAXIMUM THORACIC AORTIC DIAMETER MEASURED 59MM, UNCHANGED FROM PREVIOUS MEASUREMENTS, WITH NO OBSERVED ENDOLEAKS. THE MAXIMUM JUXTA-RENAL AORTIC ANEURYSM DIAMETER WAS APPROXIMATELY 53MM, CONSISTENT WITH PRIOR MEASUREMENTS. INTERVENTION OCCURRED 12 DAYS LATER , INVOLVING TEVAR, RELINING OF RENAL ARTERY STENTS, AND SPLENIC ARTERY EMBOLIZATION. IT WAS NOTED ON AN UNKNOWN DATE, INTERVAL INCREASE IN SIZE OF THE JUXTA RENAL AORTIC ANEURYSM MEASURING 55MM ALONG WITH POSTSURGICAL CHANGES OF THE OPEN DESCENDING THORACOABDOMINAL AORTIC ANEURYSM REPA

  Patient problems: Insufficient Information; Pain; Unspecified Infection

  MAUDE report 19319651 ↗
• InjuryJun 26, 2020Difficult or Delayed Positioning; Difficult or Delayed Positioning

  A VALIANT NAVION STENT GRAFT WAS PLANNED FOR IMPLANTATION IN THE PATIENT FOR THE TREATMENT OF A PAU OF THE ASCENDING AORTA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE AN ATTEMPT TO INSERT THE DEVICE VIA THE LEFT SIDE WAS MADE BUT IT COULD NOT BE ADVANCED. THE PHYSICIAN ACCESSED THE RIGHT CAROTID AND CLOSED THE LEFT FEMORAL AND THE CASE WAS COMPLETED. AT THE END OF THE PROCEDURE IT WAS OBSERVED THAT THERE WAS A DISSECTION OF THE LEFT FEMORAL AND A REPAIR WITH A CUT-DOWN AND A PATCH WAS PERFORMED. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO SMALL FEMORAL AND ILIAC VESSELS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Intimal Dissection

  MAUDE report 10199648 ↗