BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS

    MDR report key: 5569732 · Received November 24, 2015

    Report

    Report Number
    3001587388-2015-15366
    Event Type
    Injury
    Date Received
    November 24, 2015
    Date of Event
    October 6, 2015
    Report Date
    October 28, 2015
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    PMA / PMN Number
    K141227
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS COMMUNICATED TO THE MANUFACTURER THAT THE DOCTOR COULDN'T DO PRESSURE CHANGE IN VALVE. THE IMPLANT DEPTH IS SAID TO BE SUPERIOR TO 8MM WHICH IS ADVISED AGAIN BY THE MANUFACTURER IN THE PRODUCT IFU. THE PATIENT'S VENTRICLE EXPANDED, SO IT WAS EXPLANTED AND EXCHANGED WITH NEW SPVA VALVE.

    Description of Event or Problem · 1

    THE DOCTOR COULDN'T DO PRESSURE CHANGE IN THE VALVE/ THE IMPLANT DEPTH IS SAID TO BE SUPERIOR TO 8MM (IN THE IFU, SOPHYSA STATES THAT THE IMPLANT DEPTH SHOULD NOT BE SUPERIOR TO 8MM). THE PATIENT'S VENTRICLE EXPANDED; THE DEVICE WAS EXPLANTED AND REPLACED BY A NEW SPA VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    779084 POLARIS SHUNT, CENTRAL NERVOUD SYSTEM AND COMPONENTS JXG SOPHYSA SA SPVA B0711

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention