BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 VALVE

    MDR report key: 8701831 · Received June 14, 2019

    Report

    Report Number
    3004721439-2019-00131
    Event Type
    Injury
    Date Received
    June 14, 2019
    Date of Event
    May 17, 2019
    Report Date
    June 19, 2019
    Manufacturer
    CHRISTOPHER METHKE 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 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 THE PROGAV 2.0 IS 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 WITH THE GIVEN TOLERANCES. RESULTS: FIRST WE PERFORMED A VISUAL INSPECTION OF THE PROGAV 2.0 VALVE. NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE VALVE WERE DETECTED DURING THE VISUAL INSPECTION. NEXT WE TESTED THE PERMEABILITY OF THE VALVE AND ADJUSTABILITY OF THE VALVE, AS WELL AS THE BRAKE FUNCTIONALITY AND BRAKE FORCE. THE PROGAV 2.0 OPERATES AS EXPECTED AND MET ALL SPECIFICATIONS. FINALLY WE HAVE DISMANTLED THE VALVE. INSIDE THE VALVE WE HAVE FOUND MINIMAL BUILD-UP OF SUBSTANCES (LIKELY PROTEIN). BASED ON OUR INVESTIGATION, WE ARE UNABLE TO SUBSTANTIATE THE CLAIM OF OCCLUSION. AT THE TIME OF OUR INVESTIGATION, THE PROGAV 2.0 WAS SHOWN TO BE PERMEABLE. 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. ASSOCIATED MEDWATCH: 3004721439-2019-00132.

    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. PATIENT DATA: HEIGHT AND GENDER UNKNOWN. IMPLANT DATE: (B)(6) 2019, EXACT DATE UNKNOWN. 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 THERE WAS AN ISSUE WITH THE PROGAV SYSTEM. THE PATIENT WAS IMPLANTED WITH A SHUNT SYSTEM IN (B)(6) 2019. POSTOPERATIVELY, THE VALVE WAS SUSPECTED TO BE BLOCKED. ON (B)(6) 2019, THE VALVE WAS EXPLANTED DUE TO THE MALFUNCTION. ADDITIONAL INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492316 PROGAV 2.0 VALVE HYDROCEPHALUS MANAGEMENT JXG CHRISTOPHER METHKE GMBH & CO. KG FX410T 20039550

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention