BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLARIS SPV KIT PREATTACHED/BO19-10

    MDR report key: 3005850 · Received February 13, 2013

    Report

    Report Number
    3001587388-2012-00242
    Event Type
    Malfunction
    Date Received
    February 13, 2013
    Date of Event
    July 6, 2012
    Report Date
    January 4, 2013
    Manufacturer
    SOPHYSA SA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE WAS RETURNED AND ANALYSED. ACCORDING TO THE LABORATORY RESULTS, THE VALVE IS CLEAN, BUT THE SPRING IS ENTIRELY COVERED BY A PROTEIN DEPOSITION, AFFECTING ITS STIFFNESS AND THUS THE VALVE PERFORMANCES. THE OBSTRUCTION OF THIS IMPLANT IS ONE OF THE MAJOR COMPLICATIONS AND IS PERFECTLY KNOWN AND DESCRIBED IN THE IFU.

    Description of Event or Problem · 1

    THE MALFUNCTIONING OF THE VALVE IMPLANTED ON (B)(6) 2011 LED TO A SURGICAL INTERVENTION TO EXTRACT IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63175 POLARIS SPV KIT PREATTACHED/BO19-10 POLARIS SPV KIT PREATTACHED/ JXG SOPHYSA SA POLARIS X0012

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR