BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV WITH SHUNTASSISTANT 30

    MDR report key: 17233571 · Received June 29, 2023

    Report

    Report Number
    3004721439-2023-00181
    Event Type
    Injury
    Date Received
    June 29, 2023
    Report Date
    June 29, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906132125
    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

    VISUAL INSPECTION: DURING THE VISUAL INSPECTION A DEFORMATION OF THE OUTER HOUSING OF THE PROGAV VALVE COULD BE DETERMINED. THE MEASUREMENT OF THE PLANE PARALLELISM COULD CONFIRM THAT WITH A VALUE OF -0,042 MM - OUTSIDE TOLERANCE (0 ± 0.02 MM). PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT ALL COMPONENTS ARE PERMEABLE. DURING THE PERMEABILITY TEST 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 VALVES ARE TESTED IN BOTH THE HORIZONTAL AS WELL AS THE VERTICAL POSITIONS. THE RESULTS SHOW THAT THE VALVES OPERATE WITHIN THE PERMISSIBLE TOLERANCE IN THEIR RESPECTIVE RELEVANT POSITIONS. ADJUSTMENT TEST: THE PROGAV 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 WITHIN THE GIVEN TOLERANCES. 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 INVESTIGATION RESULTS, WE CAN DETECT DEPOSITS IN BOTH VALVES AS WELL AS A DEFORMATION OF THE HOUSING SURFACE OF THE PROGAV®. THE DEPOSITS AND THE DEFORMATION DO NOT INFLUENCE THE TECHNICAL PROPERTIES AT THE TIME OF THE INVESTIGATION. HOW THE AFOREMENTIONED FUNCTIONAL IMPAIRMENT CAME ABOUT IS NOT CLEAR TO US AT THE TIME OF THE EXAMINATION. 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 (#FV415T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN OVER-DRAINAGE AND ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE COMPLAINT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 11 YEARS; WEIGHT: 36.6 KILOGRAMS (KG) ; HEIGHT: 147 CENTIMETERS (CM); GENDER: MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1823362 PROGAV WITH SHUNTASSISTANT 30 HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FV415T 20051710 04041906132125

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Required Intervention