BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV WITH SHUNTASSISTANT 20

    MDR report key: 15809931 · Received November 16, 2022

    Report

    Report Number
    3004721439-2022-00343
    Event Type
    Injury
    Date Received
    November 16, 2022
    Report Date
    November 16, 2022
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906132101
    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: A DEFORMATION OF THE OUTER HOUSING OF THE PROGAV VALVE WAS OBSERVED THROUGH THE VISUAL INSPECTION. THE MEASUREMENT OF THE PLANE PARALLELISM COULD CONFIRM THAT WITH A VALUE OF -0,042MM THE HOUSING MEMBRANE IS OUTSIDE TOLERANCE (0 ± 0.02 MM). SOME DEPOSITS ON THE CATHETER IS VISIBLE. PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT BOTH VALVES ARE 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 VALVES ARE TESTED IN BOTH THE HORIZONTAL AS WELL AS THE VERTICAL POSITIONS. THE RESULTS SHOW THAT THE BOTH VALVES ARE NOT OPERATING WITHIN THE ACCEPTABLE TOLERANCE IN EITHER POSITION. ADJUSTMENT TEST: THE PROGAV WAS TESTED AND IS LIMITED ADJUSTABLE. 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 VALVES, DEPOSITS WERE FOUND IN BOTH VALVES. TO MAKE THE PROTEINS / DEPOSITS IN THE SHUNT SYSTEM MORE VISIBLE, THEY WERE COLORED USING A STAINING SOLUTION. RESULTS : BASED ON OUR EXAMINATION RESULTS, WE CAN DETERMINE AN ACCELERATED, SLOWER OUTFLOW AND LIMITED ADJUSTABILITY ON THE SHUNT SYSTEM. THE CAUSE OF THE SLOWER/ACCELERATED OUTFLOW AND LIMITED ADJUSTABILITY COULD BE THE DETECTED DEPOSITS. DEPOSITS CAUSED BY SUBSTANCES NATURALLY PRESENT IN THE BODY, SUCH AS PROTEIN, BLOOD OR TISSUE PARTICLES, ARE AMONG THE KNOWN AND UNAVOIDABLE RISKS AND SIDE EFFECTS OF HYDROCEPHALUS THERAPY. WE CAN EXCLUDE A DEFECT AT THE TIME OF RELEASE. THE SHUNT SYSTEM 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 SHUNTSYSTEM (PART # FV413T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN OVERDRAINAGE AND DIFFICULT TO ADJUST.. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 12 YEARS. HEIGHT: 150 CENTIMETERS (CM). WEIGHT: 40 KILOGRAMS (KG). GENDER: MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1829748 PROGAV WITH SHUNTASSISTANT 20 HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FV413T 20011812 04041906132101

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Required Intervention