Valiant Navion™ VNMC2222C94TU (UDI 00763000100919)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00763000100919), received between Aug 27, 2020 and Jun 23, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR TREATMENT .  IT WAS REPORTED THE PATIENT HAD A  SURGERY FOLLOWED BY  POST-OPERATIVE CLINICAL VISIT THE FOLLOWING MONTH . IT WAS SAID BOTH THE SURGERY AND POST-OP VISIT ARE RELATED TO THE PATIENTS HISTORY OF THE PRIOR PLACEMENT OF THE RECALLED VALIANT NAVION STENT GRAFT.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information; Obstruction/Occlusion

  MAUDE report 17189185 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED FOR THE ENDOVASCULAR REPAIR POST A BLUNT TRAUMATIC AORTIC INJURY (TRANSECTION). THE PATIENT PRESENTED WITH AN AORTIC TEAR (TRANSECTION) AT THE LEVEL OF THE LSA. POST TEVAR ANGIOGRAM SHOWED THAT THE INJURED SEGMENT HAD BEEN SUCCESSFULLY COVERED. IT WAS REPORTED ONE MONTH POST THE INDEX PROCEDURE THE PATIENT HAS REGAINED CONSCIOUSNESS HOWEVER IS SUFFERING FROM PARALYSIS. PER THE PHYSICIAN THE CAUSE OF THE PARALYSIS IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Paralysis

  MAUDE report 10815580 ↗
• InjuryAug 27, 2020Difficult to Remove; Device Dislodged or Dislocated; Difficult to Remove; Device Dislodged or Dislocated

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 185MM RAPIDLY EXPANDING MYCOTIC PSEUDOANEURYSM. THE PSEUDOANEURYSM WAS LOCATED JUST DISTAL TO THE LEFT SUBCLAVIAN ARTERY. IT WAS NOTED THE PATIENT HAD COARCTATION OF THE AORTA THAT HAD PREVIOUSLY BEEN TREATED WITH A BARE METAL STENT BEING IMPLANTED ON AN UNKNOWN DATE. THE ANEURYSM WAS BETWEEN THE LSA AND COARCTATION. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE VALIANT NAVION WAS DELIVERED SUCCESSFULLY TO THE INTENDED LOCATION FROM THE LEFT FEMORAL ARTERY OVER A STIFF GUIDEWIRE. A SELECTIVE PIGTAIL CATHETER WAS USED TO MARK THE CORRECT LANDING ZONE WHILE USING ANGIOGRAPHY ALSO. THE PHYSICIAN DEPLOYED THE DEVICE, BY FIRST ROTATING THE BLUE SLIDER HANDLE ON THE DELIVERY SYSTEM TO FULLY DEPLOY THE MAIN BODY OF THE DEVICE, THEN RELEASED THE TIP CAPTURE MECHANISM TO FULL DEPLOY THE PROXIMAL COVERED STENT AT THE INTENDED LOCATION. THEN UNDER FLUOROSCOPY, THE PHYSICIAN BEGAN THE DELIVERY SYSTEM REMOVAL PROCESS: THE ENTIRE SYSTEM WAS PULLED DISTALLY UNTIL THE NOSE CONE WAS WITHIN THE GRAFT, THE TRIGGER ON THE BLUE SLIDER WAS PULLED AND BROUGHT THE GRAY HANDLE BACK DOWN TO THE BLUE SLIDER. LIVE X-RAY WAS T

  Patient problems: Injury

  MAUDE report 10459234 ↗