BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVITOR VISION

    MDR report key: 24944952 · Received April 21, 2026

    Report

    Report Number
    2135147-2026-02619
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    January 30, 2026
    Report Date
    April 21, 2026
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPT
    UDI-DI
    05415067045782
    PMA / PMN Number
    P190023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    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

    CLINICAL INFORMATION: CRD_1059 - VISTA NOVA STUDY, PATIENT SITE ID: SITE ID- (B)(6). IT WAS REPORTED THAT ON (B)(6) 2026, A 25MM NAVITOR VISION VALVE WAS CHOSEN FOR IMPLANT USING A SMALL FLEXNAV DELIVERY SYSTEM. A PRE-IMPLANT BALLOON VALVULOPLASTY WAS DONE WITH A 22MM NON-ABBOTT BALLOON. THE ACTIVATED CLOTTING LEVELS WERE 256S AND HEPARIN WAS GIVEN. THE VALVE GOT SUCCESSFULLY IMPLANTED. ON (B)(6) 2026, THE PATIENT HAD ATRIAL FIBRILLATION DIAGNOSED FOLLOWING THE ONSET FATIGUE AND SHORTNESS OF BREATH AT THE SLIGHTEST ACTIVITY. A NON OBSTRUCTIVE BIOPROSTHETIC THROMBOSIS WAS NOTED IN THE LEFT ATRIUM. A LOW MOLECULAR WEIGHT HEPARIN WAS GIVEN TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574766 NAVITOR VISION AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT ABBOTT MEDICAL NVRO-25 10949495 05415067045782

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention