Valiant Navion™ VNMF3434C97TU (UDI 00763000100636)Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00763000100636), received between Nov 29, 2019 and Nov 16, 2023 — classified as 4 deaths, 2 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (4 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  TWO VALIANT CAPTIVIA STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF A DESCENDING THORACIC AORTIC IMH WITH A HEMOTHORAX. THE 34X30X150 WAS IMPLANTED JUST DISTAL TO LEFT SUBCLAVIAN ARTERY WHILE THE OTHER VALIANT CAPTIVIA WAS IMPLANTED JUST PROXIMAL TO THE CELIAC WITH GOOD OVERLAP. 1 YEAR AND 10 MONTHS LATER , THE PATIENT WAS DIAGNOSED WITH A TYPE B AORTIC DISSECTION WHICH HAD EXTENDED PROXIMALLY INTO THORACO-ABDOMINAL AORTA, AND DISTALLY INTO ILIAC ARTERIES. THE PATIENT HAD PRESENTED WITH LLE LIMB ISCHEMIA SECONDARY TO THE DISSECTION AS WELL AS CHEST AND BACK PAIN. THEREFORE AS TREATMENT A 34X34X97 VALIANT NAVION STENT GRAFT WAS IMPLANTED OVERLAPPING THE PROXIMAL CAPTIVIA STENT GRAFT. AN ENDURANT II AUI WAS IMPLANTED AND EXTENDED WITH TWO ENDURANT LIMBS INTO THE RIGHT ILIAC ARTERY. THREE YEARS AND NINE MONTHS LATER, THE PATIENT PRESENTED EMERGENTLY WITH ALTERED MENTAL STATUS. A CT OF THE HEAD AND NECK WAS PERFORMED AS WELL AS A CT OF THE CHEST/ABDOMEN WITH CONTRAST. THE HEAD/NECK CT SHOWED THE FOLLOWING; THERE IS CONTRAST OPACIFICATION EXTENDING INTO THE INTRAMURAL HEMATOMA ON POSTCONTRAST IMAGES AT THE LEVEL OF THE DISTAL ASCENDING AORTA. THIS AREA HAS PROGRESSIVELY FI

  Patient problems: Ischemia; No Clinical Signs, Symptoms or Conditions; Pain; Vascular Dissection

  MAUDE report 18150272 ↗
• MalfunctionSep 28, 2023Leak/Splash; Leak/Splash

  AN ENDURANT II STENT GRAFT EXTENSION CUFF (ETTF3636C70E) AND A VALIANT NAVION STENT GRAFT (VNMF3434C97TU) WAS IMPLANTED DURING THE TREATMENT OF A 65MM ANEURYSM . IT WAS REPORTED DURING FOLLOW-UP CT IMAGING TAKEN, THE PATIENTS CT IMAGE REVEALED THE PROXIMAL AND DISTAL STENT GRAFTS LACK OF APPOSITION TO THE AORTA / SEAL ZONES. PER THE PHYSICIAN THE CAUSE OF THE STENT GRAFTS LACK OF APPOSITION WAS DUE TO DISEASE PROGRESSION OF THE AORTA. NO ADDITIONAL CLINICAL SEQUALAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17832099 ↗
• DeathSep 20, 2023Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  VALIANT NAVION STENT GRAFT WAS IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A COMPLEX THORACOABDOMINAL ANEURYSM. IT WAS REPORTED APPROXIMATELY 11 MONTHS POST THE INDEX PROCEDURE, FOLLOW UP CT SCAN REVEALED AN EXPANDING TYPE IIIA ENDOLEAK, DISTAL TO THE LEVEL OF THE AORTIC HIATUS, WHICH WAS SUBSEQUENTLY TREATED WITH AORTIC COILING. APPROXIMATELY 2 YEARS POST THE INDEX PROCEDURE, THE PATIENT REQUIRED AN ENDOGRAFT REVISION DUE TO THE TYPE III ENDOLEAK IT WAS REPORTED THE PATIENT PRESENTED APPROXIMATELY 3 YEARS POST THE INDEX PROCEDURE WITH A TWO-DAY HISTORY OF ABDOMINAL PAIN. A CTA IDENTIFIED AN ENLARGING ABDOMINAL AORTIC ANEURYSM, WHICH HAD INCREASED FROM 60MM TO 70MM SINCE 10 MONTHS PREVIOUS.  THE PRIOR REPAIR INVOLVED THE PLACEMENT OF FOUR-VESSEL CHIMNEY STENT GRAFTS AND ILIAC STENTS, AND THE PATIENT HAD RECEIVED MULTIPLE TREATMENTS TO ADDRESS PERSISTENT ENDOLEAKS. THE PATIENT UNDERWENT AN RT AX-FEM PROCEDURE, FOLLOWED BY AN OPEN THORACIC AORTA TO BILATERAL CFA BYPASS THE NEXT DAY WHICH INCLUDED A FOUR-VESSEL MESENTERIC BYPASS, PARTIAL ENDOGRAFT EXPLANTATION, AND SPLENECTOMY. THE PATIENT EXPERIENCED PULMONARY FAILURE, LEADING TO AN EXTENDED STAY IN ICU, INCLUDING MULTIPLE BRONCHO

  Patient problems: Abdominal Pain; Aneurysm; Hypoxia; Pleural Empyema; Respiratory Failure

  MAUDE report 17782268 ↗
• MalfunctionDec 14, 2022Leak/Splash; Leak/Splash

  VALIANT NAVION STENT GRAFTS WERE IMPLANTED DURING THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC DISSECTION ON THE (B)(6) 2020. THE 34 X 223 MM VALIANT NAVION ENDOGRAFT WAS DEPLOYED AT THE DISTAL ARCH AND THE 34 X 182 MM GRAFT WAS DEPLOYED WITH ADEQUATE OVERLAP UP TO THE CELIAC AXIS. IT WAS REPORTED 10 DAYS POST THE INDEX PROCEDURE AN ADDITIONAL VALIANT NAVION GRAFT ((B)(4)) WAS IMPLANTED DUE TO A TYPE IA ENDOLEAK. IT WAS NOTED DURING ONE OF THE PROCEDURES ''LARGE TRILOBED BALLOON WAS UTILIZED AND THE ENDOGRAFT WAS BALLOONED AT THE OVERLAPPING SEGMENT AND THE PROXIMAL SEGMENT UNDER RAPID PACING. ANGIOGRAPHY REVEALED ENDOLEAK WITH ADEQUATE FLOW IN THE LEFT CAROTID AND LEFT SUBCLAVIAN ARTERY. IT WAS UNCLEAR IF THIS WAS TYPE I OR TYPE II AND BECAUSE AND TO BETTER DELINEATE THIS AND POTENTIALLY RE-INTERVENE A DECISION WAS MADE TO STOP AT THIS POINT." IT WAS REPORTED APPROXIMATELY 2 MONTHS POST THE INDEX PROCEDURE FOLLOW UP CT OBSERVED A TYPE I ENDOLEAK. THE CAUSE OF THE ENDOLEAK IS UNDETERMINED. NO ADDITIONAL CLINICAL SEQUELAE WERE PROVIDED AND THE PATIENT WILL BE MONITORED.

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

  MAUDE report 15976288 ↗
• DeathMay 21, 2021Leak/Splash; Leak/Splash

  A VALIANT NAVION STENT GRAFT SYSTEM WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN UNKNOWN SIZE THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT A CT WAS PERFORMED, WHERE AN ENDOLEAK TYPE IIIA WAS IDENTIFIED. NO CAUSE OF THE EVENT WAS REPORTED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unspecified Infection

  MAUDE report 11862069 ↗
• DeathMar 9, 2021Malposition of Device; Malposition of Device

  TWO VALIANT NAVION STENT GRAFTS WERE IMPLANTED IN THE ENDOVASCULAR TREATMENT OF UN UNKNOWN PRE-RUPTURED THORACIC AORTIC ANEURYSM. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, PATIENT'S BLOOD PRESSURE DROPPED AND DURING DEPLOYMENT OF THE STENT GRAFT, THE PHYSICIAN FELT THAT THE STENT GRAFT PULLED BACK WHILE DEPLOYING, SO THE PHYSICIAN THEN PUSHED THE STENT GRAFT FORWARD, WHICH COVERED THE LEFT CAROTID ARTERY. THE PHYSICIAN STATED THAT THEY WERE LANDING AT THE LEVEL OF THE LEFT CAROTID AND COVERING THE LEFT SUBCLAVIAN. FINAL ANGIOGRAM WAS PERFORMED, WHERE IT WAS NOTED THAT THE LEFT CAROTID ARTERY WAS COVERED WITH THE STENT GRAFT AND THE PATIENT SUFFERED A STROKE. APPROXIMATELY 6 DAYS LATER, THE PATIENT DIED. AS PER THE PHYSICIAN, CAUSE OF THE EVENT WAS DUE A TYPE 3 AORTIC ARCH ANATOMY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED. PATIENT IS EXPIRED.

  Patient problems: Ischemia Stroke; Obstruction/Occlusion; Stroke/CVA

  MAUDE report 11445712 ↗
• InjuryDec 13, 2019Malposition of Device; Malposition of Device

  A VALIANT NAVION STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A THORACIC AORTIC ULCER. IT WAS REPORTED THAT DURING THE INDEX PROCEDURE, THE ANGIOGRAM WAS PERFORMED TO MARK THE LEVEL OF THE LEFT CAROTID. WHILE POSITIONING AND DEPLOYING THE DEVICE, THE PATIENT AWOKE AND MOVED AND THE LEFT CAROTID WAS UNINTENTIONALLY COVERED BY THE STENT GRAFT. A CUTDOWN OF THE CAROTID WAS PERFORMED TO EXPOSE IT AND A COVERED STENT WAS PLACED AS A SNORKEL TO RE-ESTABLISH FLOW TO THE VESSEL. THE LEFT ARM WAS REPAIRED WITH A VEIN GRAFT. ON WAKING THE PATIENT CODED, CPR WAS PERFORMED AND THEY RECOVERED BY THE LEFT ARM WAS ISCHEMIC. A CAROTID TO BRACHIAL BYPASS WAS THE PERFORMED TO FIX THE BLOOD FLOW TO THE ARM AND ON LAST UPDATE THE PATIENT IS ALERT AND MOVING THEIR EXTREMITIES. AS PER THE PHYSICIAN, THE CAUSE OF THE EVENT IS ANATOMY RELATED FOR THE ISCHEMIC ARM AND BECAUSE THE PATIENT AWOKE DURING PLACEMENT OF THE VALIANT NAVION. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT WILL BE MONITORED.

  Patient problems: Cardiac Arrest; Ischemia; Occlusion

  MAUDE report 9465778 ↗
• DeathNov 29, 2019Adverse 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 TRANSECTION. IT WAS REPORTED THAT TWO DAYS LATER THE PATIENT CODED AND SUBSEQUENTLY EXPIRED. PER THE PHYSICIAN THE CAUSE OF DEATH IS CURRENTLY UNKNOWN BUT NOT CONSIDERED DEVICE RELATED AND POSSIBLE PROCEDURE RELATED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT HAS EXPIRED.

  Patient problems: Death

  MAUDE report 9391336 ↗