Valiant Navion™ VNMC3737C52TU (UDI 00763000101046)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000101046), received between Sep 19, 2019 and Sep 18, 2020 — classified as 1 death, 2 injuries.

The most frequently reported specific device problem is “Leak/Splash” (2 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.

• InjurySep 18, 2020Leak/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 A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT APPROXIMATELY 6 MONTHS POST INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL WITH CHEST PAIN AND WEAKNESS. IT WAS STATED THAT A NEW DISSECTION WAS FOUND PROXIMALLY TO THE PROXIMAL GRAFT. THE EVENT WAS TREATED WITH A LEFT CAROTID TO LEFT SUBCLAVIAN BYPASS TWO DAYS LATER AND A TEVAR FOUR DAYS LATER WHERE A VNMF4040C183TU WAS IMPLANTED AS TREATMENT ALTHOUGH THE DEVICE DID NOT LAND AS CLOSE TO THE CAROTID ARTERY AS HAD BEEN PLANNED, A VNMF4040C103TU WAS THEN IMPLANTED ADDITIONALLY AS A PROXIMAL EXTENSION TO COMPLETE THE PROCEDURE. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS ANATOMY. THE PATIENT HAS HAD THREE SEPARATE DISSECTIONS. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE

  Patient problems: Intimal Dissection; Pseudoaneurysm; Vascular Dissection

  MAUDE report 10552739 ↗
• DeathJun 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS USED IN THE ENDOVASCULAR TREATMENT OF A 79MM THORACIC AORTIC ANEURYSM. IT WAS NOTED THAT THE PATIENTS PROXIMAL THORACIC AORTIC DIAMETER WAS 32MM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN RAPIDLY PACED THE PATIENT'S BLOOD PRESSURE TO 180 AND DEPLOYED THE STENT GRAFT TO THE INTENDED LOCATION TO COVER THE ANEURYSM. THE PATIENT BRIEFLY LOST HER PULSE AND CHEST COMPRESSIONS WERE GIVEN. THE PATIENT RECOVERED BUT THE PHYSICIAN PLACED THE PATIENT ON A PUMP TO HELP HER RECOVER AND THE DEVICE WAS REMOVED AND A 16FR SHEATH PLACED IN THE LEFT FEMORAL ACCESS FOR HAEMOSTASIS. THE PATIENT RESPONDED AND WAS TAKEN OFF THE PUMP AND ANGIORAM PERFORMED SHOWED NO ENDOLEAK. HOWEVER, A SMALL, NON FLOW LIMITING DISSECTION COULD BE SEEN AT THE AORTIC BIFURCATION. WHEN THE 16FR SHEATH WAS ATTEMPTED TO BE MOVED, THE LEFT COMMON ILIAC SEPARATED FORM THE AORTIC BIFURCATION AND THE PATIENT RUPTURED. THERE WAS NO WIRE ACCESS FROM THE LEFT AS THE PIGTAIL WAS BEING USED FOR ANGIOGRAM AND ATTEMPTS TO REENGAGE THE WIRE TO PLACE AN OCCLUSIVE BALLOON WERE UNSUCCESSFUL. THE PATIENT DIED. THE CAUSE OF THE EVENT WAS ANATOMY RELATED DUE TO THE RUPTURED LEFT ILIAC TRAN

  Patient problems: Death; Intimal Dissection; Perforation of Vessels

  MAUDE report 10194019 ↗
• InjurySep 19, 2019Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ASCENDING AORTIC ANASTOMOTIC LEAK. THE PATIENT PREVIOUSLY UNDERWENT AN OPEN ASCENDING AORTIC REPAIR THAT HAD LEAKAGE AT THE DISTAL ANASTOMOSIS AND THE NAVION STENT GRAFT WAS IMPLANTED TO TRY TO RESOLVE THE LEAK. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE STENT GRAFT WAS IMPLANTED SUCCESSFULLY AND IMMEDIATE POST-OP IMAGING SHOWED NO LEAK. HOWEVER, FOLLOW-UP CT ON AN UNKNOWN DATE SHOWED THAT THE LEAK WAS STILL PRESENT. AN INTERVENTION WAS CARRIED OUT DURING WHICH AN ADDITIONAL VALIANT NAVION WAS IMPLANTED TO COVER THE INITIAL LEAK. INTRA-OPERATIVE ANGIO SHOWED NO LEAK AFTER IMPLANT OF THE SECOND NAVION. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS THAT THE INITIAL NAVION STENT GRAFT DID NOT COVER THE ANASTOMOTIC LEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 9085930 ↗