BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 SYS W/SA25 A.CONTROL RESERV.

    MDR report key: 8501466 · Received April 10, 2019

    Report

    Report Number
    3004721439-2019-00085
    Event Type
    Injury
    Date Received
    April 10, 2019
    Date of Event
    March 18, 2019
    Report Date
    April 29, 2019
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K161853
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 MANUFACTURING SITE EVALUATION: VISUAL INSPECTION - SHUNT SYSTEM SCRATCHES ON THE OUTER HOUSING OF THE PROGAV VALVE AND HUMAN TISSUES ON THE RESERVOIR WERE OBSERVED THROUGH THE VISUAL INSPECTION. NO SIGNIFICANT DEFORMATIONS OR DAMAGE WERE DETECTED. PERMEABILITY TEST- THE TEST HAS SHOWN THAT BOTH VALVES ARE PERMEABLE. ADJUSTMENT TEST - THE PROGAV VALVE WAS TESTED AND IS ADJUSTABLE TO ALL SPECIFIED PRESSURES. THE BRAKING FORCE/FUNCTION TEST - THE TEST HAS SHOWN THAT THE BRAKE FUNCTION IS FULLY OPERATIONAL AND THE BRAKING FORCE IS WITHIN THE GIVEN TOLERANCES. RESULTS - AFTER THE ABOVE TESTS, WE HAVE DISMANTLED THE VALVES. INSIDE THE VALVE AND RESERVOIR WE HAVE FOUND A BUILD-UP OF SUBSTANCES (LIKELY PROTEIN). THERE WERE NO VISIBLE DEPOSITS INSIDE THE SHUNT ASSISTANT. HOWEVER, EVEN A SMALL AMOUNT OF NON-VISIBLE BLOOD OR PROTEIN CAN LEAD TO TEMPORARY BLOCKAGE AND COULD BE RESPONSIBLE FOR THE SUSPECTED MALFUNCTION IN THE PAST. WE SUSPECT THAT THE DEPOSITS IN THE VALVE IN THE RESERVOIR COULD HAVE CAUSED MALFUNCTION. BASED ON OUR INVESTIGATION, WE ARE UNABLE TO SUBSTANTIATE THE CLAIM OF OCCLUSION. THE VALVES OPERATE WITHIN THE SPECIFIED TOLERANCES. HOWEVER, IT IS POSSIBLE THAT THE DEPOSITS OBSERVED INSIDE THE VALVES COULD HAVE TEMPORARILY OCCLUDED THE SYSTEM 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 VALVE MET ALL SPECIFICATIONS OF THE FINAL INSPECTION WHEN RELEASED 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. SECTION A - PATIENT DATA: HEIGHT 180 CM. MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROGAV VALVE WAS BLOCKED. A PATIENT UNDERWENT A SHUNT SYSTEM IMPLANTATION ON (B)(6) 2018. SOMETIME LATER, BLOCKAGE WAS NOTED. ON (B)(6) 2019, THE SHUNT WAS REPLACED DUE TO MALFUNCTION. FURTHER DETAILS WERE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291944 PROGAV 2.0 SYS W/SA25 A.CONTROL RESERV. HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO. KG FX435T 20038523

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention