Valiant Navion™ VNMC4343C95TURecalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000101138), received between Jul 1, 2019 and Jan 3, 2023 — classified as 2 deaths, 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (3 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. IT WAS REPORTED CORE LAB REVIEW OF CT IMAGING ON (B)(6) 2019 IDENTIFIED A NEW TYPE IA ENDOLEAK. NO STENT FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION WERE OBSERVED. THE IMAGING WAS NOTED AS N/A FOR AORTIC ENLARGEMENT. CORE LAB REVIEW OF CT IMAGING ON (B)(6) 2019 IDENTIFIED A PERSISTANT TYPE IA ENDOLEAK. NO STENT FRACTURE, STENT RING ENLARGEMENT, STENT RING MIGRATION OR AORTIC ENLARGEMENT WAS OBSERVED. THE CAUSE OF THE TYPE IA ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16085458 ↗
• InjurySep 8, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED FOR A 250 MM THORACIC AORTIC DISSECTION ON THE (B)(6) 2019. IT WAS REPORTED THAT APPROXIMATELY 44 MONTHS POST THE INDEX PROCEDURE, THE PATIENT PRESENTED EMERGENTLY TO THE HOSPITAL COMPLAINING OF BACK PAIN. CTA WAS PERFORMED, WHERE A ENDOLEAK TYPE IIIB INTO THE ANEURYSM WAS REVEALED. INTERVENTION WAS COMPLETED WHERE A 40 X 40 X 200 MM NON-MEDTRONIC THORACIC STENT GRAFT WAS IMPLANTED TO RELINE THE AREA AFFECTED AND EXCLUDE THE ANEURYSM. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS THAT THE VALIANT NAVION GRAFT APPEARS TO HAVE EXPANDED IN AN UNSUPPORTED STENT AND LEAK OCCURRED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information; Pain

  MAUDE report 15377715 ↗
• DeathDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED THAT THE PATIENT RETURNED FOR A CT SCAN WHERE A POSSIBLE TYPE A DISSECTION WAS OBSERVED. THE PATIENT WAS SENT TO HOSPITAL FOR SURGICAL EVALUATION AND THE PATIENT SUBSEQUENTLY EXPIRED IN HOSPITAL 11 DAYS POST THE INDEX PROCEDURE. NO CAUSE OF THE DISSECTION WAS PROVIDED.  THE CAUSE OF DEATH IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Insufficient Information; Vascular Dissection

  MAUDE report 12949518 ↗
• DeathDec 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING AN UNKNOWN THORACIC ENDOVASCULAR PROCEDURE . IT WAS REPORTED THAT THE PATIENT EXPIRED 2 DAYS LATER. THE CAUSE OF DEATH IS UNKNOWN & NOT RELATED TO THE DEVICE. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT HAS EXPIRED.

  Patient problems: Insufficient Information

  MAUDE report 12932698 ↗
• InjuryOct 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT DURING THE ENDOVASCULAR TREATMENT OF A PAU..  IT WAS REPORTED ON AN UNKNOWN DATE APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THE PHYSICIAN HAD COMPLETELY RELIGNED THE PATIENT'S STENT GRAFTS WITH A NON-MEDTRONIC GRAFT DURING AN URGENT CASE THAT WAS DONE FOR  THAT WAS DONE FOR A SYMPTOMATIC PENETRATING ULCER OF THE THORACIC AORTA DISTAL TO THE GRAFT . THE GRAFT WAS ALSO EXTENDED DISTALLY.  IT WAS STATED THAT THE EVENT HAS RESOLVED.  NO CAUSE OF THE PENETRATING AORTIC ULCER WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Ulcer

  MAUDE report 12630327 ↗
• InjuryNov 21, 2019Difficult to Remove; Deformation Due to Compressive Stress; Device Damaged by Another Device; Difficult to Remove; Deformation Due to Compressive Stress; Device Damaged by Another Device

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT AS A PROXIMAL EXTENSION, FOR THE ENDOVASCULAR TREATMENT OF AN THORACOABDOMINAL AORTIC ANEURYSM. THE MID TO DISTAL DESCENDING THORACIC AORTA MEASURING 80MM AT ITS GREATEST DIMENSION. THE PATIENT WAS ALSO TREATED FOR A INFRARENAL AND EXTERNAL ANEURYSM MEASURING 60MM AT ITS GREATEST DIMENSION. THE CASE WAS A PHYSICIAN SPONSORED IDE. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE DEVICE WAS IMPLANTED SUCCESSFULLY. HOWEVER, DURING REMOVAL OF THE DELIVERY SYSTEM, IT BECAME CAUGHT ON A SUPRARENAL STENT AND WAS KINKED. THIS WAS RESOLVED BY BALLOONING THE STENT GRAFT AND RELINING IT WITH ANOTHER NAVION DEVICE. THE INVESTIGATOR ASSESSED THE CAUSE OF THE EVENT WAS POSSIBLE DUE TO BE AN OPERATOR ERROR AND NOT A DEVICE MALFUNCTION. THREE ADVERSE EVENTS HAVE BEEN FURTHER REPORTED: INTRA-ABDOMINAL HEMORRHAGE WHICH IS CONFIRMED AS RESOLVED WITH SEQUELAE, ACUTE KIDNEY INJURY WHICH IS REPORTED AS ONGOING AND LEFT KIDNEY INFARCT WHICH IS ALSO ONGOING. PER THE INVESTIGATOR THE CAUSE OF THESE ADVERSE EVENTS IS NOT KNOWN THE RELATIONSHIP OF THESE EVENTS TO THE NAVION DEVICE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Injury; Renal Failure

  MAUDE report 9352846 ↗
• MalfunctionAug 13, 2019Difficult to Remove; Difficult to Remove

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 53 MM DIAMETER THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, AFTER FULL DEPLOYMENT OF THE STENT GRAFT, THE PHYSICIAN HAD DIFFICULTY RECAPTURING THE DELIVERY SYSTEM PRIOR TO REMOVAL. IT WAS REPORTED THAT RETRACTING THE TRIGGER ON THE SLIDER WAS NOT DISENGAGING IT FROM THE SCREW GEAR THREADS. AFTER THE PHYSICIAN MOVED THE SLIDER BACK AND FORTH AND RETRACTED AND RELEASED THE TRIGGER MULTIPLE TIMES, THE DELIVERY SYSTEM WAS EVENTUALLY RECAPTURED AND REMOVED FROM THE PATIENT. IT WAS NOTED THAT DURING TROUBLESHOOTING, THE PHYSICIAN MADE SURE THAT THE DELIVERY SYSTEM WAS BEING HELD STRAIGHT AND THAT THE FRONT GRIP AND SLIDER WERE NOT BEING SQUEEZED TOO TIGHTLY. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8887885 ↗
• InjuryJul 1, 2019Leak/Splash; Difficult to Remove; Device Damaged by Another Device; Leak/Splash; Difficult to Remove; Device Damaged by Another Device

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 40MM DIAMETER THORACOABDOMINAL ANEURYSM. THE PATIENT HAD A PREVIOUS TALENT ABDOMINAL STENT GRAFT SYSTEM IMPLANTED APPROXIMATELY ELEVEN YEARS EARLIER. IT WAS NOTED THAT THERE WAS NO FAILURE TO THE PREVIOUS GRAFT AND THE AORTA HAD CONTINUED TO ELONGATE. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PHYSICIAN PLACED THE DEVICE AND ATTEMPTED TO REMOVE THE DELIVERY SYSTEM, GOING FROM THE GREY HANDLE TO THE BLUE, HOWEVER IT WOULD NOT ADVANCE. THE PHYSICIAN THEN TWISTED THE DEVICE WITHOUT LOOKING DISTALLY THROUGH THE PREVIOUSLY IMPLANTED AAA DEVICE. IT WAS THEN NOTED THAT THE AAA LIMB HAD WRAPPED AROUND THE NAVION DELIVERY SYSTEM. THE DELIVERY SYSTEM COULD NOT BE REMOVED FROM THE PATIENT. THE PHYSICIAN THEN BROKE DOWN THE DELIVERY SYSTEM TO ATTEMPT TROUBLESHOOTING, HOWEVER THE DELIVERY SYSTEM COULD STILL NOT BE REMOVED FROM THE PATIENT. AT THIS POINT, THE PHYSICIAN PERFORMED A CUT DOWN ON THE ACCESS SITE ON THE PATIENT'S RIGHT SIDE. THEY THEN CUT THE DELIVERY SYSTEM, LEAVING THE NOSE CONE AND TIP CAPTURE INSIDE THE PATIENT. A FEM-FEM BYPASS WAS THEN CARRIED OUT. TEN DAYS LATER FURTHER

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8748471 ↗