BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV SYS M.SA 20 U.CONTROL RESERVOIR

    MDR report key: 15677118 · Received October 26, 2022

    Report

    Report Number
    3004721439-2022-00323
    Event Type
    Injury
    Date Received
    October 26, 2022
    Date of Event
    September 22, 2022
    Report Date
    October 26, 2022
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906132460
    PMA / PMN Number
    K103003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING AND QUALITY CONTROL DATA. THE PROGAV® SHUNT SYSTEM WAS MANUFACTURED BY A QUALIFIED EMPLOYEE IN APRIL 2016. DEVIATIONS DURING ASSEMBLY DID NOT OCCUR. THE SYSTEM WAS STERILIZED BY MIETHKE AND RELEASED FOR SHIPMENT AFTER FINAL INSPECTION. FOR THE PURPOSES OF THIS INVESTIGATION, THE PROSA® SHUNT SYSTEM IS COMPRISED OF A PROGAV® ADJUSTABLE PRESSURE VALVE WITH A NORMAL PRESSURE RANGE OF 0 TO 20 CMH2O AND A SHUNTASSISTANT® FIXED PRESSURE VALVE WITH A FIXED PRESSURE STAGE OF 20 CMH2O. THE SHUNT SYSTEM WAS INSPECTED AS ARTICLE FV434T. ALL PARAMETERS HAVE BEEN INSPECTED AND APPROVED DURING THE MANUFACTURING PROCESS. ALL PARAMETERS HAVE BEEN ASSESSED AS MEETING SPECIFICATIONS. VISUAL INSPECTION: STRONGLY CONTAMINATED WITH TISSUE RESIDUES PERMEABILITY TEST: A PERMEABILITY TEST HAS INDICATED THAT THE PROGAV® AND THE SHUNTASSISTANT® HAVE A BLOCKAGE AND THE CONTROL RESERVOIR IS PERMEABLE. ADJUSTMENT TEST: THE PROGAV® WAS TESTED AND IS NOT ADJUSTABLE THROUGHOUT THE NORMAL RANGE. 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. (SEE SECTION 2.6). 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 A BLOCKAGE AT THE TIME OF OUR EXAMINATION ON THE SHUNT SYSTEM. THE CAUSE OF NON-ADJUSTABILITY COULD BE THE DEPOSITS DETECTED. 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. EVEN SMALL AMOUNTS OF PROTEIN CAN COMPROMISE THE INTEGRITY OF THE VALVE. 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 # FV434T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM WAS BELIEVED TO BE OPERATED IN UNDERDRAINAGE AND WAS DIFFICULT TO ADJUST. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 9 YEARS AND 2 MONTHS, HEIGHT: 130 CENTIMETERS (CM), WEIGHT: 26 KILOGRAMS (KG), GENDER: FEMALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2801940 PROGAV SYS M.SA 20 U.CONTROL RESERVOIR HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FV434T 20030145 04041906132460

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Female Required Intervention