BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR TRANSCATHETER AORTIC VALVE

    MDR report key: 24901596 · Received April 16, 2026

    Report

    Report Number
    2135147-2026-02465
    Event Type
    Injury
    Date Received
    April 16, 2026
    Date of Event
    March 22, 2026
    Report Date
    April 16, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINS IMPLANTED IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. 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 THAT ON (B)(6) 2026, A 29MM NAVITOR VISION VALVE WAS SELECTED FOR IMPLANT USING AN UNKNOWN FLEXNAV DELIVERY SYSTEM (DS). DURING THE PROCEDURE, THE VALVE WAS ABLE TO BE IMPLANTED. POST-IMPLANT, GRADIENT WAS 6MMHG. ON 22 MAR. 2026, THE PATIENT WAS REPORTED WITH A HIGH GRADIENT MEASURED TO BE 56MMHG AND PRESENTED WITH A CHIEF COMPLAINT OF FATIGUE. HEPARIN WAS ADMINISTERED TO RESOLVE THIS EVENT. GRADIENT WAS REDUCED TO 20MMHG. THE PATIENT WAS IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    577626 NAVITOR TRANSCATHETER AORTIC VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL UNK NAVITOR

    Patients

    Seq Age Sex Outcome Treatment
    1