Valiant Navion™ VNMC4337C200TU (UDI 00763000101268)Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00763000101268), received between Aug 2, 2019 and Aug 20, 2024 — classified as 1 death, 4 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 20, 2024Fracture; Leak/Splash; Detachment of Device or Device Component; Fracture; Leak/Splash; Detachment of Device or Device Component

  TWO VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION AS PART OF THE DISSECT-N STUDY. IT WAS REPORTED THAT A FOLLOW-UP CT TAKEN 11 MONTHS LATER SHOWED THE MAXIMUM AORTIC DIAMETER OF 44MM. CORELAB REVIEW OF CT IMAGES DATED (B)(6) 2022 SHOWED AORTIC ENLARGEMENT OF +8.6MM PROXIMAL TO THE ENDOGRAFT. IT WAS NOTED THAT THERE WAS NO STENT RING ENLARGEMENT AND NO FRACTURE SEEN ON THE CT AND THE IMAGING WAS NON-EVALUABLE FOR ENDOLEAKS. SITE REVIEW OF CT SCAN 17 MONTHS LATER IDENTIFIED A TYPE IIA ENDOLEAK. A CT SCAN 3 YEARS AND 2 MONTHS POST THE INDEX PROCEDURE SHOWED ANEURYSMAL DILATION OF ASCENDING AORTA DILATED *NOT WITHIN STENT GRAFT*. UP TO 7X6.7CM COMPARED TO PRIOR (6.4X6.3CM) CT IMAGING WAS PERFORMED 3 YEARS AND 5 MONTHS POST THE INDEX PROCEDURE WAS REVIEWED BY CORELAB. A NEW TYPE IIIB ENDOLEAK WAS IDENTIFIED ON (B)(6). A NEW FRACTURE ON RING 4 WAS NOTED ON (B)(6). NEW STENT RING ENLARGEMENT OF + 3.6MM ON RING 4, + 2.1MM ON RING 5 AND + 2.3MM ON RING 6 ON STENT GRAFT (B)(6) WAS ALSO OBSERVED. NO STENT RING MIGRATION WAS NOTED. THE MAXIMUM AORTIC DIAMETER MEASURED 69.9MM THE CAUSE OF THE EVENT IS UNDETERMINED. NO ADDITIONAL CLI

  Patient problems: Aneurysm

  MAUDE report 20006268 ↗
• DeathJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC DISSECTION. THE PATIENT HAD ADDITIONAL NON MDT DEVICES IMPLANTED DURING THE PROCEDURE (ADDITIONAL DEVICES IMPLANTED; SMA (VBX9X39X135, 37X173), CELIAC (IC9X38X120), BILATERAL ILIAC (18X90X75)) IT WAS REPORTED ONE DAY POST THE INDEX PROCEDURE THE PATIENT SUFFERED REFRACTORY SHOCK AND EXPIRED ON THIS DATE. PER THE PHYSICIAN THE CAUSE OF DEATH IS UNDETERMINED.

  Patient problems: Shock

  MAUDE report 16223310 ↗
• MalfunctionJun 9, 2022Leak/Splash; Material Deformation; Leak/Splash; Material Deformation

  2 VALIANT NAVION THORACIC STENT GRAFT WERE IMPLANTED FOR THE ENDOVASCULAR TREATMENT OF A 61MM THORACIC ANEURYSM.  IT WAS REPORTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE ON FOLLOW UP CT A TYPE III ENDOLEAK AND STENT RING ENLARGEMENT WERE IDENTIFIED.  PER THE PHYSICIAN, THE EVENT IS RELATED WITH THE FAILURE OF THE SUTURE AND STENT RING ENLARGEMENT RESULTING IN A TYPE III  ENDOLEAK.  NO ADDITIONAL SEQUELAE WAS REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14641987 ↗
• InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM . IT WAS REPORTED ON FOLLOW UP CT DEMONSTRATED AORTIC ENLARGEMENT WITH ANEURYSMAL DILATION OF THE FALSE LUMEN OF THE MID DESCENDING AORTA. THE FLOW WAS NOTED TO BE GOOD, BUT THERE IS AN INCREASE IN SIZE OF THE AORTA FROM 65MM TO 75MM. AN ADDITIONAL VALIANT NAVION WAS IMPLANTED. THE PHYSICIAN HAS NOTED THAT POSTOPERATIVELY, THE PATIENT DID WELL BUT DEVELOPED RESIDUAL FENESTRATIONS IN THE SUBCLAVIAN ARTERIES AND DISTAL THORACIC AORTA. THE CAUSE OF THE AORTIC ENLARGEMENT AND RESIDUAL FENESTRATIONS WERE NOT PROVIDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Aneurysm

  MAUDE report 14285139 ↗
• MalfunctionMar 28, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING AN UNKNOWN ENDOVASCULAR PROCEDURE. IT WAS REPORTED BY THE PATIENTS WIFE THAT FOLLOW UP CT ON AN UNKNOWN DATE IDENTIFIED ENDOLEAKS. THE CAUSE OF THE ENDOLEAKS ARE UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13929321 ↗
• InjuryJan 25, 2022Material Deformation; Adverse Event Without Identified Device or Use Problem; Material Deformation; Adverse Event Without Identified Device or Use Problem

  A VALIANT NAVION WAS IMPLANTED DURING AN ENDOVASCULAR PROCEDURE FOR THE TREATMENT OF A THORACIC AORTIC ANEURYSM ON AN UNKNOWN DATE. IT WAS REPORTED ON AN UNKNOWN DATE THE PATIENT PRESENTED EMERGENTLY WITH CHEST PAIN. IT WAS DISCOVERED THE PATIENTS ANEURYSM HAD RUPTURED, THE PATIENT UNDERWENT AN INTERVENTION PROCEDURE DUE TO RETROPERITONEAL HEMATOMA AND LEFT ANEURYSM.  AS PER THE PHYSICIAN THE CAUSE OF THE EVEN COULD NOT BE DETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WAS PROVIDED AND THE PATIENTS STATUS IS UNKNOWN.

  Patient problems: Chest Pain; Hematoma; Rupture

  MAUDE report 13342172 ↗
• MalfunctionOct 29, 2020Difficult to Remove; Malposition of Device; Material Deformation; Difficult to Remove; Malposition of Device; Material Deformation

  A VALIANT NAVION STENT GRAFT WAS IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A 65MM THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE DEVICE DEPLOYED WITHOUT ISSUE. DURING THE REMOVAL OF THE DELIVERY SYSTEM, IT GOT CAUGHT ON THE GRAFT AND PULLED IT BACK. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDEDAND THE PATIENT IS FINE.

  Patient problems: Insufficient Information; No Consequences Or Impact To Patient

  MAUDE report 10754365 ↗
• InjuryJun 2, 2020Adverse 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 UNKNOWN SIZED AORTIC DISSECTION. IT WAS REPORTED ALMOST THREE MONTHS LATER VIA TECHNICAL SERVICES, THAT THE PATIENTS'S WIFE REPORTED THE PATIENT HAD PARALYSIS FOLLOWING THE SURGERY. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Paralysis

  MAUDE report 10107813 ↗
• InjuryAug 2, 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 A THORACIC AORTIC DISSECTION, FROM THE LSA TO THE ABDOMINAL AORTA. IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, A 37/90 VALIANT NAVION STENT GRAFT WAS IMPLANTED AT THE LCC AND WAS THEN EXTENDED WITH A 43/37/200 VALIANT NAVION, WITH PERFECT OVERLAP. IT WAS REPORTED THAT THE PHYSICIANS WERE THEN CONCERNED THAT THE 37/90 VALIANT NAVION WAS ENCROACHING ON THE LCC, AND THEY DECIDED TO PLACE AN 8/29 BALLOON-EXPANDABLE BARE STENT FOR ACCESS. IT WAS REPORTED THAT ON THE DAY AFTER THE PROCEDURE, THE PATIENT PRESENTED EMERGENTLY WITH AN RTAD. AN OPEN REPAIR WAS PERFORMED AS TREATMENT. 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: Intimal Dissection

  MAUDE report 8854090 ↗