Valiant Navion™ VNMC3434C90TU (UDI 00763000260804)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00763000260804), received between Jan 5, 2021 and Oct 18, 2023 — classified as 3 injuries, 2 malfunctions.

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

• MalfunctionOct 18, 2023Leak/Splash; Leak/Splash

  THREE VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A TAA. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE FOLLOW-UP CT SHOWED A STABLE ENDOLEAK ALONG THE MID TO LOWER THORACIC AORTA ON THE RIGHT AT THE JUNCTION OF THE MAIN THORACIC STENT GRAFT AND SMALLER BRANCH GRAFTS. 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 17956769 ↗
• MalfunctionFeb 9, 2023Material Deformation; Material Deformation

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION ON 01-SEP-2020. IT WAS REPORTED APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE, FOLLOW UP CT SHOWS AORTIC ENLARGEMENT FROM 36MM TO 41MM. PER THE PHYSICIAN THE CAUSE OF THE AORTIC ENLARGEMENT IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED. CORE LAB REVIEW OF CT IMAGING FROM 26-OCT-2022 IDENTIFIED NEW STENT RING ENLARGEMENT OF 1.3MM ON VNMC3434C90TU (V29984150). THE MAX AORTIC DIAMETER WAS NOTED AS 41.6MM. THE IMAGING DID NOT IDENTIFY ANY ENDOLEAK OR STENT FRACTURE. NO STENT RING MIGRATION WAS OBSERVED. THE IMAGING WAS NOTED ASNA FOR AORTIC ENLARGEMENT.

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

  MAUDE report 16333490 ↗
• InjuryMay 6, 2022Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION ON (B)(6) 2021. IT WAS REPORTED 7 MONTHS POST THE INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH PSEUDOANEURYSM WHEN A CTA REVEALED THE NEW INJURY TO THE AORTA IMMEDIATELY DISTAL TO THE STENT. PATIENT IS ASYMPTOMATIC. THE PATIENT WAS SET UP WITH A PRIMARY CARE PHYSICIAN FOR BETTER BLOOD PRESSURE MANAGEMENT. AND FREQUENT CT MONITORING. A SITE IMAGING REVIEW OF THE 7 MONTH CT'S SHOWED A MAXIMUM AORTIC DIAMETER OF 41MM, WITH THE PRESENCE OF A NEW INDUCED ENTRY TEAR AND A NEW OUTPOUCHING DISTAL TO STENT. CORELAB REVIEW OF CT IMAGES FROM THE SAME DATE IDENTIFIED AORTIC ENLARGEMENT OF +7.0MM DISTAL TO GRAFT. THERE WAS NO STENT RING ENLARGEMENT, ENDOLEAK OR FRACTURE OBSERVED. SITE IMAGING REVIEW OF CT'S FROM APPROXIMATELY 4 MONTHS LATER, DATED (B)(6) 2021 SHOWED A MAXIMUM AORTIC DIAMETER OF 45MM WITH A PRESENCE OF A NEW INDUCED ENTRY TEAR AND NO CHANGES IN SMALL PSEUDOANEURYSM. CORELAB REVIEW OF CTS FROM THE SAME DATE IDENTIFIED A TYPE R ENTRY FLOW AND AORTIC ENLARGEMENT OF +7.8MM DISTAL TO GRAFT. THERE WAS NO STENT RING ENLARGEMENT, ENDOLEAK OR FRACTURE OBSERVED. PER THE SITE, THE CAUSE OF T

  Patient problems: Pseudoaneurysm; Vascular Dissection

  MAUDE report 14301345 ↗
• InjuryJan 20, 2021Fracture; Leak/Splash; Detachment of Device or Device Component; Fracture; Leak/Splash; Detachment of Device or Device Component

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 80 MM THORACIC AORTIC DISSECTION. IT WAS REPORTED APPROXIMATELY 23 MONTHS POST INDEX THE PATIENT PRESENTED EMERGENTLY ON THE WITH WORSENING UPPER SCAPULAR AND BACK PAIN. AN LARGE CONTAINED RUPTURE OF APPROXIMATELY GREATER THAN 100MM WAS NOTED. IT WAS STATED THAT THE EXISTING STENT GRAFT APPEARED TO BE COMPLETELY RUPTURED AT APPROXIMATELY THE SIXTH STENT WITH COMPLETE DISINTEGRATION OF FABRIC AND NITINOL STENTS. IT WAS STATED THAT THE PATIENT WAS TAKING EMERGENTLY TO THE OPERATING ROOM WHERE WIRES AND CATHETERS WERE USED TO RE-INTERROGATE THE EXISTING STENT AND THEN FOUR ADDITIONAL STENTS REPLACED THE DAMAGED STENT. FINAL ANGIOGRAPHY WERE REVEALED NO ENDOLEAK WITH GOOD STENT TO VESSEL WALL OPPOSITION. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS DEVICE EROSION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

  Patient problems: Pain; Rupture

  MAUDE report 11202152 ↗
• InjuryJan 5, 2021Adverse 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 THORACIC AORTIC DISSECTION. A FOLLOW-UP CTA OVER A MONTH LATER REVEALED A NEW DISSECTION WHICH WAS BELOW THE ORIGINAL DISSECTION AND ALSO TWO NEW PENETRATING AORTIC ULCERS. THE SITE ASSESSED AS NOT RELATED TO DEVICE AND PROCEDURE. THE SPONSOR ASSESSED IT AS RELATED TO THE DEVICE AND RELATED TO THE PROCEDURE. NO CAUSE WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Ulcer; Vascular Dissection

  MAUDE report 11116065 ↗