BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 VALVE

    MDR report key: 21730672 · Received March 31, 2025

    Report

    Report Number
    3004721439-2025-00099
    Event Type
    Injury
    Date Received
    March 31, 2025
    Date of Event
    March 18, 2025
    Report Date
    March 31, 2025
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906136529
    PMA / PMN Number
    K161853
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: DURING THE INVESTIGATION, NO SIGNIFICANT DEFORMATION OR DAMAGE OF THE VALVE WAS DETERMINED. PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT THE VALVE IS PERMEABLE. COMPUTER CONTROLLED TEST: TO INVESTIGATE THE CLAIM OF UNDER-DRAINAGE, THE OPENING PRESSURE IS MEASURED USING A MIETHKE COMPUTER CONTROLLED TESTING APPARATUS WHICH SIMULATES A CEREBROSPINAL FLUID FLOW. THE VALVE IS TESTED IN THE HORIZONTAL POSITION. THE RESULTS SHOW THAT THE VALVE OPERATES WITHIN THE ACCEPTED TOLERANCES IN THE HORIZONTAL POSITION. ADJUSTMENT TEST: THE PROGAV 2.0 WAS TESTED AND IS ADJUSTABLE FROM 0 TO 18 CMH2O. 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. INTERNAL INSPECTION: AFTER DISMANTLING OF THE VALVE, ORGANIC DEPOSITS WERE FOUND IN PROGAV 2.0. TO MAKE THE DEPOSITS IN THE VALVES MORE VISIBLE, THEY WERE COLORED WITH A STAINING SOLUTION. RESULT: BASED ON OUR INVESTIGATION RESULTS, WE CAN DETERMINE THAT THE PROGAV 2.0 CAN ONLY BE PARTIALLY ADJUSTED. THE DEPOSITS VISIBLE IN THE VALVE HAVE LED TO THE FUNCTIONAL IMPAIRMENT. HOW THE AFOREMENTIONED MALFUNCTION OF THE UNDERDRAINAGE OCCURRED IS NOT CLEAR TO US AT THIS POINT IN TIME. DEPOSITS OF NATURAL SUBSTANCES FOUND IN THE BODY, SUCH AS PROTEIN, BLOOD OR TISSUE PARTICLES, ARE AMONG THE KNOWN AND UNAVOIDABLE RISKS AND SIDE EFFECTS OF HYDROCEPHALUS THERAPY. EVEN SMALL AMOUNTS OF ORGANIC DEPOSITS CAN IMPAIR THE INTEGRITY OF THE VALVE. THE EXAMINATION OF THE RETURN SHIPMENT WAS COMPLETED WITH THE PREPARATION OF THIS REPORT. 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. NO FURTHER REGULATORY ACTIONS ARE REQUIRED FROM OUR POINT OF VIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROGAV 2.0 (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE AND HAD ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2025. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. THE COMPLAINED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055010 PROGAV 2.0 VALVE HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX410T 20079235 04041906136529

    Patients

    Seq Age Sex Outcome Treatment
    1 7 MO Female Required Intervention