Valiant Navion™ VNMC4040C55TU (UDI 00763000101084)Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00763000101084), received between Dec 31, 2018 and Oct 12, 2023 — classified as 3 injuries, 3 malfunctions.

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

• MalfunctionOct 12, 2023Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT ((B)(6)) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACOABDOMINAL AORTIC ANEURYSM. 5 E NDURANT STENT GRAFTS WERE ALSO IMPLANTED TO EXCLUDE THE ABDOMINAL ANEURYSM.  IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE, A FOLLOW UP CT REVEALED STABLE THORACIC AORTIC ECTASIA/ANEURYSM REMAINED STABLE, BUT SMALL ENDOLEAKS WERE OBSERVED ALONG THE THORACOABDOMINAL ENDOLUMINAL STENT GRAFT WITHIN THE DESCENDING THORACIC AORTA. THE TYPE OF ENDOLEAK WAS NOT SPECIFIED. PER THE PHYSICIAN THE CAUSE OF THE UNKNOWN ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17918764 ↗
• MalfunctionJul 7, 2023Fracture; Leak/Splash; Detachment of Device or Device Component; Fracture; Leak/Splash; Detachment of Device or Device Component

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 55MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED ONE MONTH POST THE INDEX PROCEDURE, FOLLOW UP CT IDENTIFIED A TYPE II ENDOLEAK. CORE LAB REVIEW OF CT IMAGING FROM (B)(6) 2023 IDENTIED A NEW STENT FRACTURE ON RING 1 OF THE NAVION GRAFT. NEW STENT RING ENLARGEMENT OF +1.8MMM WAS OBSERVED ON RING 1 OF THE STENT GRAFT. NO ENDOLEAK OR STENT RING MIGRATION WAS OBSERVED. THE MAX AORTIC DIAMETER WAS NOTED AS 72.2MM WITH THE IMAGING NOTED AS N/A FOR AORTIC ENLARGEMENT. THE CAUSE OF THE STENT FRACTURE AND STENT RING ENLARGEMENT ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE P ATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17279299 ↗
• InjuryAug 19, 2020Difficult to Remove; Device Damaged by Another Device; Difficult to Remove; Device Damaged by Another Device

  AN ENDURANT IIS, ENDURANT LIMB AND VALIANT NAVION STENT GRAFT WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 80MM SYMPTOMATIC ABDOMINAL AORTIC ANEURYSM. IT WAS DECIDED PRE-EVAR THAT THE PATIENT WAS NOT A CANDIDATE FOR OPEN REPAIR THUS THE PHYSICIAN OPTED FOR OFF-LABEL TREATMENT OF THE LARGE SYMPTOMATIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THAT DUE TO THE PATIENTS VERY DIFFICULT ANATOMY AND THE C-ARM IMAGING, THE DELIVERY SYSTEM OF THE VALIANT NAVION STENT GRAFT GOT CAUGHT ON THE METAL STENTS ON TOP OF THE LIMB GRAFT. MANY ATTEMPTS WERE MADE TO DISLODGE THE DELIVERY SYSTEM BUT THIS PROVED UNSUCCESSFUL. OPEN CONVERSION WAS INITIATED AND ALL THE STENT GRAFTS WERE EXPLANTED, AND THE DELIVERY SYSTEM REMOVED. THE PATIENT WAS RECOVERING IN ICU CRITICAL CARE. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT WAS ANATOMY. IT WAS REPORTED THE INFRA-RENAL NECK ANGLE WAS GREATER THAN 90 DEGREES. WHEN THE ENDURANT WAS IMPLANTED, THE BEND AT THE AORTIC NECK WAS SO DRAMATIC THAT IT BENT THE GRAFT AT THE LEVEL OF FLOW DIVIDER, THUS EXPOSING THE SCALLOPED METAL STENTS ON THE LIMB. AS A RESULT, THE SPINDLE OF THE NAVION DELIVERY SYSTEM GOT STUCK ON THESE STENTS. NO ADDITIONAL CLIN

  Patient problems: Injury

  MAUDE report 10425313 ↗
• MalfunctionFeb 27, 2020Defective Component; Defective Component

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A CADAVER AS PART OF AN R <(>&<)>D PRE-CLINICAL TRIAL AT A MEDTRONIC PHYSIOLOGICAL RESEARCH LAB. IT WAS REPORTED THAT DURING THE PROCEDURE WHEN THE DEVICE WAS REMOVED FROM ITS PACKAGING AND PREPARED FOR USE IT WAS NOTED THAT THE TAPERED TIP WAS SEPARATED FROM THE GRAFT COVER RADIOPAQUE MARKER (I.E THERE WAS A GAP NOTED). THE SPACE BETWEEN THE TAPERED TIP AND THE DISTAL EXTENT OF THE GRAFT COVER WAS APPROXIMATELY 5-7MM. IT WAS DECIDED TO CONTINUE TO IMPLANT THE DEVICE AND THE DEVICE WAS SUCCESSFULLY INTRODUCED, TRACKED AND DEPLOYED AS EXPECTED, WITH THE PROCEDURE OBSERVED BY AN ATTENDING PHYSICIAN. THE CAUSE OF THE EVENT IS UNKNOWN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9762593 ↗
• InjuryMar 20, 2019Material Deformation; Material Deformation

  A 6 CM VALIANT NAVION CUFF WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A THORACIC PSEUDOANEURYSM AT THE ANASTOMOSIS SITE OF A PREVIOUS OPEN REPAIR. THE NAVION CUFF WAS DEPLOYED UNDER RAPID PACING. IT WAS REPORTED 3 WEEKS POST THE INDEX PROCEDURE THE PATIENT RETURNED FOR A FOLLOW UP,CTA IDENTIFIED THAT THE PSEUDOANEURYSM HAD NOT BEEN EXCLUDED. TO TREAT THIS EVENT, THE PHYSICIAN DEPLOYED A SECOND NAVION CUFF SUCCESSFULLY. PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS THAT THE DEVICE HAD ¿STACKED¿ ALONG THE GREATER CURVATURE AND LOST SEAL ALTHOUGH THAT HAD NOT BEEN IDENTIFIED IN ANY WAY. IT WAS NOTED THAT THE FIRST THREE PROXIMAL STENTS MAY HAVE NESTED, RESULTING IN DISPLACEMENT OF THE PROXIMAL FABRIC EDGE ALONG THE OUTER CURVE OF THE ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8435522 ↗
• InjuryDec 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ULCER. IT WAS REPORTED THAT THE PATIENT HAD A GOOD 1 WEEK POST OPERATIVE SCAN, HOWEVER PRESENTED WITH AN ASCENDING AORTIC DISSECTION AT THE 1 MONTH SCAN. THE DISSECTION WAS VISIBLE PROXIMAL TO AND BEHIND THE IMPLANTED DEVICE. THE PATIENT HAS NOT RECEIVED TREATMENT, AS THE PHYSICIAN OPTED FOR OBSERVATION. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT MAY BE DEVICE OVERSIZING, BUT FEELS THE ISSUE RELATES TO THE IMH AND WEAK TISSUE IN THE PATIENT'S ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Intimal Dissection

  MAUDE report 8206317 ↗