BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 WITH SHUNTASSISTANT 25

    MDR report key: 8612838 · Received May 15, 2019

    Report

    Report Number
    3004721439-2019-00128
    Event Type
    Injury
    Date Received
    May 15, 2019
    Date of Event
    May 2, 2019
    Report Date
    June 19, 2019
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K141687
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF CHRISTOPH MIETHKE GMBH & CO. KG (MANUFACTURER, REGISTRATION NO. 3004721439). EXEMPTION NUMBER: E2017044 INVESTIGATION: INVESTIGATION: VISUAL INSPECTION: NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE VALVES WERE DETECTED DURING THE VISUAL INSPECTION. PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT BOTH VALVES ARE PERMEABLE. ADJUSTMENT TEST: THE PROGAV 2.0 VALVE WAS TESTED AND IS ADJUSTABLE TO ALL SPECIFIED PRESSURES. BRAKING FORCE AND BRAKE FUNCTION TEST: THE BRAKE FUNCTIONALITY TEST HAS SHOWN THAT THE BRAKE FUNCTION IS FULLY OPERATIONAL AND THE BRAKING FORCE IS WITHIN THE GIVEN TOLERANCES. RESULTS: ADDITIONALLY, WE TESTED THE ADJUSTABILITY AS WELL AS THE BRAKE FUNCTIONALITY AND BRAKE FORCE OF THE PROGAV 2.0 VALVE. THE VALVE OPERATED AS EXPECTED AND MET ALL SPECIFICATIONS. FINALLY WE HAVE DISMANTLED THE VALVES. INSIDE BOTH VALVES WE HAVE FOUND SIGNIFICANT BUILD-UP OF SUBSTANCES (LIKELY PROTEIN). BASED ON OUR INVESTIGATION, WE ARE UNABLE TO SUBSTANTIATE THE CLAIM OF OCCLUSION OR NON-ADJUSTABILITY. AT THE TIME OF OUR INVESTIGATION, THE VALVES WERE SHOWN TO BE PERMEABLE AND THE PROGAV 2.0 WAS ADJUSTABLE TO ALL SETTINGS. HOWEVER, IT IS POSSIBLE THAT THE DEPOSITS OBSERVED INSIDE THE VALVE COULD HAVE CAUSED THE MALFUNCTION IN THE PAST. AS DESCRIBED IN OUR LITERATURE, THE PROBLEM ENCOUNTERED IS ONE OF THE KNOWN, INEVITABLE RISKS OF HC-THERAPY BY SHUNT IMPLANTS. WE CAN EXCLUDE A DEFECT AT THE TIME OF RELEASE. THE SHUNT SYSTEM MET ALL SPECIFICATIONS OF THE FIN INSPECTION WHEN RELEASE FROM CHRISTOPH MIETHKE GMBH & CO. KG.

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF CHRISTOPH MIETHKE GMBH & CO. KG (MANUFACTURER, REGISTRATION NO. 3004721439). EXEMPTION NUMBER: E2017044. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLOCKED VALVE AND NOT ADJUSTABLE. THE EXPLANTED PRODUCT WERE DELIVERED TO MIETHKE WITH THE RETURN KIT INSIDE AN UNKNOWN LIQUID. THE FILE IS ENTERED WITH LIMITED INFORMATION. HEIGHT = 62 CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406326 PROGAV 2.0 WITH SHUNTASSISTANT 25 HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO. KG FX414T 20038680

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO