BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 VALVE

    MDR report key: 19861295 · Received July 30, 2024

    Report

    Report Number
    3004721439-2024-00231
    Event Type
    Injury
    Date Received
    July 30, 2024
    Date of Event
    July 9, 2024
    Report Date
    July 30, 2024
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 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 OVER- 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 NOT ADJUSTABLE TO ALL PRESSURE SETTINGS. BRAKING FORCE AND BRAKE FUNCTION TEST: THE BRAKE FUNCTIONALITY TEST HAS SHOWN THAT THE BRAKE FUNCTION IS OPERATIONAL. HOWEVER, THE BRAKING FORCE CANNOT BE MEASURED DUE TO THE LIMITED ADJUSTABILITY OF THE VALVE. INTERNAL INSPECTION: AFTER DISMANTLING OF THE VALVE, DEPOSITS WERE FOUND IN PROGAV 2.0. TO MAKE THE PROTEINS / DEPOSITS IN THE VALVE MORE VISIBLE, THEY WERE COLORED USING A STAINING SOLUTION. RESULT : IN ADVANCE, WE WOULD LIKE TO POINT OUT THAT THE PRODUCT SENT IN WAS NOT SUBMERGED IN LIQUID AT THE TIME OF DELIVERY. THE TESTING OF DRY VALVES IS ONLY OF LIMITED VALUE. THE PRODUCT PROPERTIES CAN BE INFLUENCED BY DRY RESIDUES OF CEREBROSPINAL FLUID OR BLOOD. DESPITE THIS, WE HAVE EXAMINED THE VALVE. BASED ON THE INVESTIGATION RESULTS, IT COULD BE DETERMINE ADJUSTMENT DIFFICULTIES IN THE VALVE. THE DETERMINED DEPOSITS CAN BE NAMED AS THE CAUSE FOR THE FUNCTIONAL DEVIATION. ORGANIC MATTER IN THE CEREBROSPINAL FLUID CAN INFLUENCE THE FUNCTION TEMPORARILY AND ARE KNOWN SIDE EFFECTS IN HYDROCEPHALUS THERAPY. A DEFECT AT THE TIME OF RELEASE CAN BE EXCLUDED. THE VALVE MET ALL SPECIFICATIONS OF THE FINAL INSPECTION WHEN RELEASED FROM CHRISTOPH MIETHKE GMBH & CO. KG.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROGAV 2.0 (#FX410T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN OVERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 8 YEARS, 5 MONTHS, HEIGHT: 132 CM, WEIGHT: 24 KG, GENDER: MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    208061 PROGAV 2.0 VALVE HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX410T 20047313

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male Required Intervention