BEUDAMED
    FDA Adverse Event Death Summary report: N

    NAVITOR VISION

    MDR report key: 23286778 · Received October 15, 2025

    Report

    Report Number
    2135147-2025-05837
    Event Type
    Death
    Date Received
    October 15, 2025
    Date of Event
    September 18, 2025
    Report Date
    December 12, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067045799
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE WERE NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE NAVITOR VALVE. HOWEVER, AN EVENT INVOLVING HYPOTENSION, OCCLUSION, AND SUBSEQUENT DEATH WAS REPORTED. A COMPREHENSIVE ASSESSMENT COULD NOT BE COMPLETED BECAUSE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED THAT ALL MANUFACTURING AND INSPECTION PROCESSES WERE PERFORMED CORRECTLY, AND THE PRODUCT MET ALL SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION, THE CAUSE OF THE REPORTED EVENTS COULD NOT BE DETERMINED. WHILE THE PATIENT¿S DEATH MAY HAVE BEEN RELATED TO PROCEDURAL CIRCUMSTANCES, THIS CANNOT BE CONFIRMED. THE REPORTED HOSPITALIZATION AND INTERVENTIONS, INCLUDING CPR AND RESUSCITATION, WERE CASE-SPECIFIC AND OCCURRED AFTER THE PATIENT RETURNED TO THE HOSPITAL. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE RELATED TO LABELING, DESIGN, OR MANUFACTURING. BASED ON MEDICAL EVALUATION: AN AUTOPSY REVEALED AN EMBOLIZED FIBROBLASTOMA IN THE LEFT MAIN CORONARY ARTERY, WHICH IS PRESUMED TO HAVE CAUSED THE INITIAL POST-TAVI DECOMPENSATION AND MAY HAVE TRIGGERED THE CASCADE OF EVENTS LEADING TO THE PATIENT¿S DEATH.

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2025 A 27MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE PATIENT'S SINUS OF VALSALVA (SOV) WAS MEASURED AT 35MM ON THE LEFT SOV, 33MM ON THE RIGHT SOV AND 34MM ON THE NON-SOV. THE LEFT CORONARY ARTERY HEIGHT WAS 16MM AND THE RIGHT CORONARY ARTERY HEIGHT WAS 20MM. A 22MM NON-ABBOTT BALLOON WAS USED FOR THE PRE-BALLOON AORTIC VALVULOPLASTY (BAV). AT 80% DEPLOYMENT THE IMPLANT DEPTH WAS 4.5MM FROM THE NON-CORONARY CUSP (NCC) AND 4MM FROM THE LEFT CORONARY CUSP (LCC). AT THE FINAL RELEASE, THE IMPLANT DEPTH WAS 5MM FROM THE NCC AND 5MM FROM THE LCC. THE PATIENT BEGAN DECOMPENSATING. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED, AND THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE FOLLOWING DAY THE PATIENT RECEIVED THREE CORONARY ARTERY BYPASS GRAFTS (CABG). THE PATIENT REMAINED ON ECMO. THE PATIENT HAD PROLONGED HOSPITALIZATION FOR MONITORING. ON (B)(6) 2025 THE PATIENT PASSED AWAY. AN AUTOPSY REVEALED AN AORTIC VALVE FIBROELASTOMA THAT WAS LODGED IN THE OPENING OF THE LEFT MAIN CORONARY ARTERY (LCA) THAT WAS ORIGINALLY ON THE LEAFLET. THE CAUSE OF DEATH WAS DETERMINED TO BE LCA OCCLUSION DUE TO THE AV FIBROELASTOMA.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2025 A 27MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING A LARGE FLEXNAV DELIVERY SYSTEM. THE PATIENT'S SINUS OF VALSALVA (SOV) WAS MEASURED AT 35MM ON THE LEFT SOV, 33MM ON THE RIGHT SOV AND 34MM ON THE NON-SOV. THE LEFT CORONARY ARTERY HEIGHT WAS 16MM AND THE RIGHT CORONARY ARTERY HEIGHT WAS 20MM. A 22MM NON-ABBOTT BALLOON WAS USED FOR THE PRE-BALLOON AORTIC VALVULOPLASTY (BAV). AT 80% DEPLOYMENT THE IMPLANT DEPTH WAS 4.5MM FROM THE NON-CORONARY CUSP (NCC) AND 4MM FROM THE LEFT CORONARY CUSP (LCC). AT THE FINAL RELEASE, THE IMPLANT DEPTH WAS 5MM FROM THE NCC AND 5MM FROM THE LCC. THE PATIENT BEGAN DECOMPENSATING. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED, AND THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). THE FOLLOWING DAY THE PATIENT RECEIVED THREE CORONARY ARTERY BYPASS GRAFTS (CABG). THE PATIENT REMAINED ON ECMO. THE PATIENT HAD PROLONGED HOSPITALIZATION FOR MONITORING. ON AN UNKNOWN DATE THE PATIENT PASSED AWAY. AN AUTOPSY REVEALED AN AORTIC VALVE FIBROELASTOMA THAT WAS LODGED IN THE OPENING OF THE LEFT MAIN CORONARY ARTERY THAT WAS ORIGINALLY ON THE LEAFLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2733565 NAVITOR VISION AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL NVRO-27 10388037 05415067045799

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female Death| R| H LARGE FLEXNAV DS [FNAV-DS-LG, LOT: 10714064]