Valiant Navion™ VNMC3434C182TU (UDI 00763000260811)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00763000260811), received between Oct 22, 2020 and Mar 3, 2026 — classified as 1 death, 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• DeathMar 3, 2026Leak/Splash; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED APPROXIMATELY 5 YEARS POST THE INDEX PROCEDURE, THE PATIENT WAS ADMITTED FOR NSTMI AND FLANK PAIN AND WAS BEING TREATED BY CARDIO DUE TO HIS HEART FAILURE HISTORY. DURING ADMISSION A CT SHOWED CHRONIC AORTIC DISSECTION WITH ASCENDING ENDOLEAK. VASCULAR SURGERY WAS CONSULTED AND NO ACUTE INTERVENTION WAS RECOMMENDED WITH PLANS FOR ELECTIVE SURGERY IN 1 MONTH. DURING HOSPITALIZATION, THE PATIENT DEVELOPED ACUTE UNRESPONSIVENESS REQUIRING EMERGENT INTUBATION. THE PATIENT SUFFERED AN ACUTE INFARCT IN THE RIGHT OCCIPITAL LOBE AND A CHRONIC INFARCT IN THE LEFT PARIETAL LOBE AND WAS TREATED WITH THROMBOLYTIC THERAPY FOLLOWED BY SUCCESSFUL MECHANICAL THROMBECTOMY. THE POST-PROCEDURE COURSE WAS COMPLICATED BY EPISTAXIS AND OROPHARYNGEAL AND GROIN ACCESS BLEEDING, SUSPECTED TO BE THROMBOLYTIC-INDUCED DISSEMINATED INTRAVASCULAR COAGULATION. SIX HOUR POST THROMBECTOMY HEAD CT SHOWED R P-O EVOLVING INFARCT WITH HAEMORRHAGIC CONVERSION IN THE STROKE BED AND CONTRAST STAINING. DUE TO DIC PATIENT DEVELOPED A DISTRIBUTIVE SHOCK. THIS RESULTED IN ACUTE KIDNEY INJURY. THE PATIENT SUFFERED WITH PERSISTENT FEVERS AND LEUKOCYTOSIS, LIKELY RELATED TO WORSENING ASCENDING DISSECTION WITH EN

  Patient problems: Aortic dissection; Disseminated Intravascular Coagulation (DIC); Fever; Hemorrhage/Blood Loss/Bleeding; Hemothorax; Myocardial Infarction; Pain; Pneumonia; Renal Failure; Shock; Stroke/CVA; Unspecified Infection; Vascular Dissection

  MAUDE report 24497306 ↗
• MalfunctionFeb 11, 2025Leak/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 DURING THE ENDOVASCULAR TREATMENT OF A AAA. IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN WHICH WAS REVIEWED BY CORELAB SHOWED A IB ENDOLEAK ON STENT GRAFT V30019111. NO CAUSE WAS PROVIDED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21354860 ↗
• MalfunctionJul 11, 2024Leak/Splash; Leak/Splash

  A VALIANT NAVION WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION.  A CT PERFORMED TWO MONTHS LATER IDENTIFIED A IB ENDOLEAK. IT WAS REPORTED THAT A CT WITH AND WITHOUT CONTRAST WAS PERFORMED OVER ONE YEAR LATER. THE SITE REVIEWED THIS IMAGING AND NO ENDOLEAK, MIGRATION OR FALSE LUMEN PERFUSION WERE NOTED. THE MAXIMUM AORTIC DIAMETER WAS 47MM. IT WAS NOTED THERE IS EXCELLENT FLOW INTO THE VISCERAL ARTERIES AS WELL AS THE BILATERAL FEMORAL ARTERIES.  CORELAB REVIEWED THE CT AND NOTED AORTIC ENLARGEMENT DISTAL TO ENDOGRAFT +9.4MM. NO ENDOLEAK , STENT RING ENLARGEMENT OR FRACTURE WERE NOTED.  A CT WITH AND WITHOUT CONTRAST WAS PERFORMED ON THE 20TH OF JAN 23. NO ENDOLEAK, FALSE LUMEN PERFUSION OR MIGRATION WERE NOTED BY THE SITE. THE MAXIMUM AORTIC DIAMETER WAS NOTED AS 46MM. CORELAB REVIEWED THE SAME IMAGING AND NOTED AORTIC ENLARGEMENT OF +12.4MM DISTAL TO THE ENDOGRAFT (ONGOING). NO ENDOLEAK , FRACTURE OR STENT RING ENLARGEMENT WERE NOTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 19719297 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THREE VALIANT NAVION STENT GRAFTS WERE IMPLANTED TO TREAT A THORACIC DISSECTION. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE VIA THE DISSECT-N STUDY THE PATIENT WAS DIAGNOSED WITH ANEURYSMAL DILATION OF THE VISCERAL AORTA. INTERVENTION WAS PERFORMED ON (B)(6) 2022 AND THE EVENT WAS RESOLVED WITH SEQUALAE. THE CAUSE OF THE EVENT IS UNDETERMINED. THE SITE ASSESSED THE ANEURYSM ENLARGEMENT AS RELATED TO THE DEVICE, NOT RELATED TO THE INDEX PROCEDURE AND RELATED TO THE DISSECTION. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT IS FINE.

  Patient problems: Aneurysm; Insufficient Information

  MAUDE report 17171361 ↗
• InjurySep 30, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC ANEURYSM. IT WAS REPORTED APPROXIMATLEY 19 MONTHS POST THE INDEX PROCEDURE FOLLOW UP CT IDENTIFIED A SUSPECTED TYPE III ENDOLEAK OR PSEUDOANEURYSM. PER THE PHYSICIAN THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE M ONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Pleural Effusion; Pseudoaneurysm

  MAUDE report 15519036 ↗
• MalfunctionJun 24, 2022Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 100MM THORACIC AORTIC DISSECTION .  IT WAS REPORTED THE PATIENT RETURNED FOR A CT AND THE RADIOLOGY REPORT INDICATES A TYPE III ENDOLEAK. NO CAUSE OF THE TYPE III ENDOLEAK AS PER THE PHYSICIAN WAS PROVIDED.  NO ADDITIONAL CLINICAL SEQUALAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14799230 ↗
• InjuryOct 22, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A UNKNOWN SIZED THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE PATIENT SUFFERED A LEFT SIDED STROKE. IT WAS FELT AS PER THE PHYSICIAN THE STROKE WAS A RESULT OF THE DEBRANCHING OF THE INNOMINATE AND LEFT CAROTID ARTERY AND WAS NOT A RESULT OF THE STENT GRAFT. AS PER THE PHYSICIAN THE CAUSE OF THE EVENT CAN NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED.

  Patient problems: Stroke/CVA

  MAUDE report 10717170 ↗