BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV WITH SHUNTASSISTANT 25

    MDR report key: 17761127 · Received September 15, 2023

    Report

    Report Number
    3004721439-2023-00208
    Event Type
    Injury
    Date Received
    September 15, 2023
    Report Date
    July 28, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906132118
    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 -0,046 MM - OUTSIDE TOLERANCE (0 ± 0.02 MM). PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT ALL COMPONENTS ARE 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 VALVES ARE TESTED IN BOTH THE HORIZONTAL AS WELL AS THE VERTICAL POSITIONS. THE RESULTS SHOW THAT THE PROGAV IS OPERATING WITHIN THE ACCEPTED TOLERANCE IN THE HORIZONTAL POSITION. THE SHUNT-ASSISTANT IS OPERATING NOT WITHIN THE SPECIFIED TOLERANCES IN THE VERTICAL POSITION. ADJUSTMENT TEST: THE PROGAV WAS TESTED AND IS NOT 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 NON-ADJUSTABILITY OF THE VALVE. INTERNAL INSPECTION: AFTER DISMANTLING OF THE VALVES, NO 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 A DEFORMATION AT THE HOUSING MEMBRANE AND A NON-ADJUSTABILITY OF THE PROGAV AS WELL AS AN ACCELERATED OUTFLOW AT THE SHUNTASSISTANT AT THE TIME OF OUR INVESTIGATION. THE REASON FOR THE NON-ADJUSTABILITY COULD BE THE DETECTED DEFORMATION AT THE PROGAV. HOW THE MALFUNCTION AT THE SHUNTASSISTANT CAME ABOUT IS NOT CLEAR TO US AT THE TIME OF THE INVESTIGATION. 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 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 SHUNT SYSTEM (#FV414T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDER-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: 6 MONTHS. WEIGHT: 4.8 KILOGRAMS (KG). HEIGHT: 50 CENTIMETERS (CM). GENDER: FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268983 PROGAV WITH SHUNTASSISTANT 25 HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FV414T 20061632 04041906132118

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Female Required Intervention