Valiant Navion™ VNMC3731C207TU (UDI 00763000101244)Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 00763000101244), received between Apr 17, 2019 and Apr 15, 2024 — classified as 1 death, 8 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (11 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 15, 2024Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT (VNMC3731C207TU) WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION. IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT SHOWED TYPE IA AND IB ENDOLEAKS AND AORTIC ENLARGEMENT.   THE CAUSE OF THE TYPE IA AND IB ENDOLEAKS IS UNDETERMINED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MO NITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19104751 ↗
• InjuryNov 6, 2023Fracture; Leak/Splash; Fracture; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A 100MM THORACIC AORTIC RUPTURE.  IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE, THAT THE PATIENT PRESENTED EMERGENTLY. CT IMAGING CONFIRMED THE PRESENCE OF A TYPE LLL ENDOLEAK AND A FRACTURE/LEAK IN THE VALIANT NAVION STENT GRAFTS WHICH HAD LED TO THE EXPANSION OF THE ANEURYSM / CONTAINED RUPTURE. TREATMENT WAS PERFORMED AND TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED TO REALIGN THE NAVION STENT GRAFTS  PER THE PHYSICIAN THE CAUSE OF THE TYPE III ENDOLEAK WAS ATTRIBUTED TO A DEVICE FAILURE.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 18074563 ↗
• MalfunctionJul 20, 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 REINTERVENTION OF A PRIOR AORTIC REPAIR. THE PATIENT HAD A A VALIANT CAPTIVIA SENT GRAFT IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TYPE B THORACIC DISSECTING ANEURYSM AND LEFT SUBCLAVIAN ARTERY EMBOLIZATION WITH PLUGGING APPROXIMATELY 5 YEARS PREVIOUS IT WAS REPORTED THAT CORELAB REVIEW OF CT APPROXIMATELY 4 YEARS POST THE INDEX PROCEDURE SHOWED NEW STENT RING ENLARGEMENT OF +3.6MM ON RING 4. THERE WAS NO ENDOLEAK, NO FRACTURE, NO AORTIC ENLARGEMENT AND NO STENT RING MIGRATION OBSERVED. THE MAXIMUM AORTIC DIAMETER WAS NOTED AS 64.1MM. THE HOSPITAL ANALYSIS OF THE CT SHOWED AORTIC ENLARGEMENT WITH THE VALIANT NAVION DEVICE. THE CAUSE OF THE STENT RING ENLARGEMENT IS UNKNOWN. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17361128 ↗
• InjuryJul 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A DISSECTION. IT WAS REPORTED APPROXIMATELY 9 MONTHS POST THE INDEX PROCEDURE, AN ADDITIONAL VALIANT NAVION STENT GRAFT ((B)(6)) WAS THEN IMPLANTED ON DUE TO AN UNKNOWN REASON.  IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT SHOWED AORTIC ENLARGEMENT.  NO CAUSE WAS REPORTED.  NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 17303957 ↗
• MalfunctionFeb 20, 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 APPROXIMATELY 8 MONTHS POST THE INDEX PROCEDURE IDENTIFIED A NEW TYPE IA ENDOLEAK. NO STENT FRACTURE, STENT RING ENLARGEMENT OR STENT RING MIGRATION WAS OBSERVED. THE MAX AORTIC DIAMETER WAS NOTED AS 46.5MM. THE IMAGING WAS NOTED AS NA FOR AORTIC ENLARGEMENT. 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 16404306 ↗
• InjuryOct 26, 2022Leak/Splash; Leak/Splash

  A VALIANT NAVON STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A DISSECTION.   IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY APPROXIMATELY 1 YEARS POST THE INDEX PROCEDURE WITH SEVERE LEFT FLANK AND ABDOMINAL PAIN TO THE POINT THAT THE PATIENT COULD BARELY SPEAK AND WAS BENT OVER. CT ANGIO WAS OBTAINED AND REVEALED A NEW TYPE IA ENDOLEAK MEASURING 33 X 13MM AND TOTAL DEGENERATION OF TYPE B AORTIC DISSECTION WITH SUBSTANTIAL INCREASE IN  FALSE LUMEN. INTERVENTION  WAS PERFORMED  USING NON-MEDTRONIC DEVICES:  34 X150,23 X 45 )  AND A  26 X 45 CUFF. NO CAUSE OF THE EVENTS WAS REPORTED. THE PATIENT DIED ON (B)(6) 2022 OF NON-AORTIC RELATED CAUSE.   NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT IS EXPIRED.

  Patient problems: Pain; Vascular Dissection

  MAUDE report 15672051 ↗
• MalfunctionMay 11, 2022Material Deformation; Material Deformation

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ANEURYSM. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE THAT A CT WAS PERFORMED. CORELAB HAVE REVIEWED THIS IMAGING AND FOUND TWO STENT RING ENLARGEMENTS OF +5.4MM AND +3.7MM. THE PATIENT DIED ON (B)(6) 2021, THE CAUSE OF DEATH WAS RELATED TO COVID-19 AND NOT DEVICE RELATED.

  Patient problems: Aneurysm; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14352837 ↗
• InjuryDec 3, 2021Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN THORACIC ENDOVASCULAR PROCEDURE . IT WAS REPORTED THAT A CT TAKEN SHOWED A TYPE III ENDOLEAK. THE PHYSICIAN CARRIED OUT A SECONDARY PROCEDURE TO REALIGN THE STENT GRAFT. NO CAUSE OF THE TYPE III ENDOLEAK WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Insufficient Information

  MAUDE report 12922380 ↗
• MalfunctionOct 20, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFT SYSTEMS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED BY THE PATIENTS WIFE THAT THE PHYSICIAN SAID THE PATIENT HAD AN ENDOLEAK WHICH WAS SEEN ON A CT SCAN WHICH OCCURRED ON FOLLOW UP CT. NO CAUSE WAS REPORTED FOR THE ENDOLEAK. NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12664115 ↗
• InjuryAug 5, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE PATIENT FOR AN ENDOVASCULAR TREATMENT. AFTER RECEIVING A LETTER FROM THE HOSPITAL >1 YEAR POST PROCEDURE REGARDING THE NAVION RECALL THE PATIENT BECAME CONCERNED AND A REPRESENTATIVE FOR THE PATIENT CONTACTED TECHNICAL SERVICES TO REPORT SINCE THEIR PROCEDURE THEY HAVE HAD NO FOLLOW UP. IT WAS REPORTED AFTER THE PROCEDURE THE PATIENT WAS IN ICU FOR 10 DAYS IN A MEDICALLY INDUCED COMA. THE PATIENT STILL HASN'T RECOVERED FROM THE PROCEDURE AND HAS BEEN EXPERIENCING SHORTNESS OF BREATH AND EXTREME FATIGUE WITH HIGH BLOOD PRESSURE. NO ADDITIONAL CLINICAL WERE REPORTED AND THE PATIENT WILL BE MONITORED

  Patient problems: Coma; Dyspnea; Heart Failure/Congestive Heart Failure; High Blood Pressure/ Hypertension

  MAUDE report 12281055 ↗
• DeathJun 17, 2021Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT SYSTEM WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. APPROXIMATELY 2 1/2 YEARS POST PROCEDURE, A CT IMAGES WERE REVIEWED, WHERE A ENDOLEAK TYPE 1B WAS NOTED. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions; Rupture

  MAUDE report 12017287 ↗
• MalfunctionApr 15, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED ABOUT 18 MONTHS LATER , THAT POST-OPERATIVE CT IMAGES WERE REVIEWED FOR THIS PATIENT. IT WAS NOTED THERE AS A SMALL AMOUNT OF PROXIMAL AND DISTAL CONTRAST NOTED ON CT IMAGING (TYPE IA & IB ENDOLEAKS). IT WAS SAID THE PHYSICIAN DOES NOT SEE THIS AS AN ISSUE. THERE IS NO INTERVENTION PLANNED AND NO INJURY TO THE PATIENT. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11670407 ↗
• InjuryNov 25, 2020Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 200M THORACIC AORTIC DISSECTION. IT WAS REPORTED WHEN THE PATIENT RETURNED FOR FOLLOW-UP JUST OVER A YEAR LATER, A FENESTRATION DISTAL TO THE ORIGINAL GRAFT, THAT WAS NOT COVERED AT THE INITIAL IMPLANT CAUSED A TYPE 1B ENDOLEAK AND FILLING & EXPANSION OF THE FALSE LUMEN. INTERVENTION WAS PERFORMED AND TWO STENT GRAFTS VNMC4040C175TU AND VNMC4646C95TU WERE IMPLANTED FROM THE MID OF PREVIOUSLY PLACED VALIANT NAVION ALL THE WAY TO THE CELIAC (COVERING THE FENESTRATION AND NOW ENTIRE LENGTH OF THE THORACIC AORTA). AS PER THE PHYSICIAN THE CAUSE OF THE EVENT IS ANATOMY AND A FENESTRATION DISTAL TO THE ORIGINAL GRAFT, THAT WAS NOT COVERED AT THE INITIAL IMPLANT CAUSED TYPE 1B AND FILLING & EXPANSION OF THE FALSE LUMEN. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Insufficient Information

  MAUDE report 10904923 ↗
• InjuryAug 14, 2019Adverse 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 AN ANASTOMOTIC PSEUDO ANEURYSM. IT WAS REPORTED THAT THE PATIENT PRESENTED EMERGENTLY TWO DAYS AFTER THE INDEX PROCEDURE WITH ELEVATED BLOOD PRESSURE AND CHEST PAIN. IT WAS REPORTED THAT THE PATIENT HAD AN OPEN REPAIR ON THE SAME DAY TO RESOLVE A RETROGRADE TYPE A DISSECTION THAT WAS IDENTIFIED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS UNKNOWN. THE PHYSICIAN IS UNCLEAR WHETHER THE CHEST PAIN OR ELEVATED BLOOD PRESSURE WAS THE PRIMARY ISSUE. IT WAS NOTED THAT THERE MAY HAVE BEEN AN ANOMALY IN SIZING FOR THIS PATIENT WHICH MAY BE IDENTIFIED ON IMAGING. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm; High Blood Pressure/ Hypertension; Intimal Dissection; Pain

  MAUDE report 8892675 ↗
• InjuryApr 17, 2019Malposition of Device; Malposition of Device

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 60 MM DIAMETER THORACIC AORTIC ANEURYSM. THE DIAMETER OF THE PROXIMAL THORACIC AORTA WAS 31 MM, THERE WAS MODERATE ANGULATION OF THE THORACIC ARCH, AND THE THORACIC AND ABDOMINAL AORTA WERE MODERATELY TORTUOUS. NO CALCIFICATION WAS PRESENT IN THE THORACIC AORTA. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, WHEN THE PHYSICIAN WAS DEPLOYING THE TIP CAPTURE, THE STENT GRAFT MOVED 20 MM DISTALLY FROM THE INTENDED LANDING ZONE. AN ADDITIONAL VALIANT NAVION STENT GRAFT (VNMC3737C90TU) WAS IMPLANTED TO COVER THE MISSED LANDING ZONE, AND THE PROCEDURE WAS COMPLETED. IT WAS REPORTED THAT THE DELIVERY SYSTEM AND GUIDEWIRE WERE FULLY OPPOSED TO THE OUTER CURVE OF THE AORTA. RAPID PACING WAS NOT USED. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT WAS RELATED TO THE BLOOD PRESSURE PUSHING THE DEVICE BACK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

  Patient problems: Injury

  MAUDE report 8522013 ↗