BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV VALVE

    MDR report key: 17872582 · Received October 4, 2023

    Report

    Report Number
    3004721439-2023-00289
    Event Type
    Injury
    Date Received
    October 4, 2023
    Date of Event
    September 5, 2023
    Report Date
    October 4, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906132071
    PMA / PMN Number
    K103003
    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 DEFORMATIONS OR DAMAGE OF THE VALVE WAS DETERMINED. PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT THE VALVE IS PERMEABLE. DURING THE PERMEABILITY TEST SOME PARTICLES / BLOODY LIQUID WERE FLUSHED OUT. 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 IS NOT OPERATING WITHIN THE ACCEPTABLE TOLERANCE IN THE HORIZONTAL POSITION. AN ACCELERATED OUTFLOW COULD BE DETERMINED. ADJUSTMENT TEST: THE PROGAV WAS TESTED AND IS ONLY ADJUSTABLE IN THE RANGE OF 8 TO 12CMH2O PRESSURES. 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. RESULT: BASED ON OUR INVESTIGATION RESULTS, WE CAN DETERMINE AN ACCELERATED OUTFLOW IN THE VALVE. THE DETERMINED DEPOSITS CAN BE NAMED AS THE CAUSE FOR THE ACCELERATED OUTFLOW. PROTEINS IN THE CEREBROSPINAL FLUID CAN INFLUENCE THE FUNCTION TEMPORARILY AND ARE KNOWN SIDE EFFECTS IN HYDROCEPHALUS THERAPY. 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 (#FV410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2013. ACCORDING TO THE COMPLAINANT, THE VALVE WAS BELIEVED TO BE OPERATED IN 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: 10 YEARS, HEIGHT: 132 CENTIMETERS, WEIGHT: 25 KILOGRAMS, GENDER: MALE. SAME PATIENT/EVENT AS MEDWATCH: 3004721439-2023-00290.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526587 PROGAV VALVE HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FV410T 20021393 04041906132071

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Male Required Intervention