Valiant Navion™ VNMC4040C218TU (UDI 00763000101114)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000101114), received between Mar 5, 2019 and Jun 7, 2023 — classified as 1 death, 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 7, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN AORTIC DISSECTION IT WAS REPORTED THAT ON FOLLOW UP CT SCAN FROM APPROXIMATELY 2YEAR AND 1 MONTH POST INDEX PROCEDURE, CORELAB IDENTIFIED STENT RING ENLARGEMENT OF +1.8MM ON RING 6.  THE MAXIMUM AORTIC DIAMETER WAS 54.6MM. THERE WAS NO ENDOLEAK, FRACTURE OR STENT RING DISPLACEMENT ( STENT RING MIGRATION) OBSERVED.  PER THE PHYSICIAN, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.  NO ADDITIONAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17077119 ↗
• InjuryMay 22, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. ENDOANCHORS WERE ALSO IMPLANTED ON AN UNKNOWN DATE. IT WAS REPORTED APPROXIMATELY 8 MONTHS POST THE INDEX PROCEDURE, FOLLOW UP CT IDENTIFIED A TYPE IB ENDOLEAK SUGGESTING POOR ENDOANCHOR PENETRATION TO THE VESSEL WALL DUE TO AORTIC THROMBUS, WITH ENLARGEMENT OF THE PROXIMAL PORTION OF THE DESCENDING AORTA. THE ANEURYSM SAC DIAMETER WAS NOTED TO MEASURE 95MM AND THE PATIENT WAS ASYMPTOMATIC. INTERVENTION WAS PERFORMED WITH DISTAL AND PROXIMAL EXTENSION OF THE ENDOGRAFT IMPLANTED AND THE ENDOLEAK RESOLVED. IT WAS FURTHER REPORTED A REVISION OF THE THORACOABDOMINAL ENDOGRAFT REPAIR WAS PERFORMED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE. A REVISION OF THE ANEURYSM SAC, DRAINAGE OF FLUID AND REMOVAL OF THROMBUS. IT WAS REPORTED THAT THE PATIENT HAD A LEFT THORACOABDOMINAL WOUND POST THE 2021 ANEURYSM SAC REVISION. NO CAUSE OF THE EVENT WAS PROVIDED. NO ADDITIONAL SEQUALAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 16972572 ↗
• MalfunctionFeb 13, 2023Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A TAA .  IT WAS REPORTED ON THE DATE OF THE CT , STENT RING ENLARGEMENT OF +3.4MM <(>&<)> 1.4MM WERE NOTED ON THE STENT GRAFT WITH SN (B)(4). NO STENT GRAFT MIGRATION WAS NOTED. NO FRACTURE WAS NOTED. THE MAXIMUM AORTIC DIAMETER WAS 55.3MM.  THE CAUSE OF THE EVENT COULD NOT BE DETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16361408 ↗
• DeathMay 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE AS A RE-INTERVENTION FOR A PRIOR AORTIC STENT GRAFT INFECTION. IT WAS REPORTED THAT PATIENT RETURNED FOR A FOLLOW-UP CT 4 DAYS LATER WHICH REVEALED A FISTULA AND GRAFT INFECTION. THE PATIENT EXPIRED THE NEXT DAY. AS PER THE PHYSICIAN THE CAUSE OF DEATH WAS DUE TO AORTIC RUPTURE-HEMORRHAGE FROM MEDIAL AORTIC SAC. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Fistula; Rupture; Unspecified Infection

  MAUDE report 14496230 ↗
• InjuryAug 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A TYPE B THORACIC DISSECTION. IT WAS REPORTED THE PATIENT WENT INTO A-FIB THROUGHOUT THE NIGHT THE ENDOVASCULAR STENT WAS IMPLANTED. 2 DAYS POST THE INDEX PROCEDURE THE PATIENT PRESENTED EMERGENTLY WITH A TYPE A AORTIC DISSECTION. CARDIOTHORACIC SURGERY WAS PERFORMED WHERE A SURGICAL GRAFT WAS IMPLANTED. PER THE PHYSICIAN THE TYPE A DISSECTION WAS SEPARATE FROM THE NAVION STENT GRAFT AREA. THE AREA BETWEEN THE STENT TO THE NEW TYPE A DISSECTION WAS HEALTHY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Atrial Fibrillation; Intimal Dissection

  MAUDE report 10425181 ↗
• MalfunctionMar 5, 2019Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60 MM THORACIC AORTIC ANEURYSM. DURING DEVICE PREP IT WAS FLUSHED THROUGH THE BACK PORT WITH HEPARINIZED SALINE, AND THE BUILT IN FLUSH PORT FOR THE GRAFT COVER WAS ALSO FLUSHED WITH HEPARINIZED SALINE WHILE THE TIP WAS HELD ELEVATED. IT WAS REPORTED THAT DURING DEPLOYMENT, THE BLUE HANDLE OF THE DELIVERY SYSTEM ROTATED WITHOUT DIFFICULTY, BUT WOULD NOT ENGAGE THE SCREW GEAR AND MADE A ¿CLICKING/POPPING¿ SOUND AFTER THE FIRST 2-3 ROTATIONS. THERE WAS APPROXIMATELY 0.5 INCH SEPARATION BETWEEN THE GRAY FRONT GRIP AND THE BLUE HANDLE WHEN THE CLICKING BEGAN. THE SCREW GEAR JUMPED TOWARD THE TOP OF THE DEVICE WHEN IT WAS BEING ROTATED. IT WAS REPORTED THAT EACH TIME THE SURGEON ATTEMPTED TO ROTATE THE BLUE HANDLE IT WOULD MAKE 1 ROTATION AND THEN CLICK/POP AGAIN WITHOUT ADVANCING ANY FURTHER. THE PHYSICIAN THEN DEPRESSED THE RAPID DEPLOYMENT TRIGGER AND WAS ABLE TO DEPLOY THE GRAFT WITH NO FURTHER ISSUES. THE PHYSICIAN STATED THAT THE RAPID DEPLOYMENT TOOK A LITTLE MORE STRENGTH THAN EXPECTED AND WAS SLIGHTLY MORE DIFFICULT THAN A TYPICAL RAPID DEPLOYMENT. A SECOND NAVION DEVICE (VNMC4646C218TU)

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8390934 ↗