BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 VALVE

    MDR report key: 17442512 · Received August 2, 2023

    Report

    Report Number
    3004721439-2023-00220
    Event Type
    Injury
    Date Received
    August 2, 2023
    Date of Event
    July 3, 2023
    Report Date
    August 2, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906136529
    PMA / PMN Number
    K161853
    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 INVESTIGATION, DEPOSITS ON THE DEVICE WAS DETERMINED. PERMEABILITY TEST: A PERMEABILITY TEST HAS SHOWN THAT THE VALVE IS PERMEABLE. DURING THE PERMEABILITY TEST SOME BLOODY LIQUID WERE FLUSHED OUT. 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 VALVE IS TESTED IN THE HORIZONTAL POSITION. THE RESULTS SHOW THAT THE VALVE OPERATES WITHIN THE ACCEPTED TOLERANCES IN THE HORIZONTAL POSITION. ADJUSTMENT TEST: THE PROGAV 2.0 WAS TESTED AND IS ADJUSTABLE FROM 0 TO 13 CMH2O. 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 VALVE, DEPOSITS WERE FOUND IN PROGAV 2.0. TO MAKE THE PROTEINS / DEPOSITS IN THE VALVE MORE VISIBLE, THEY WERE COLORED USING A STAINING SOLUTION. RESULT: IN ADVANCE, WE WOULD LIKE TO POINT OUT THAT THE PRODUCT SENT IN WAS NOT SUBMERGED IN LIQUID AT THE TIME OF DELIVERY. THE TESTING OF DRY VALVES IS ONLY OF LIMITED VALUE. THE PRODUCT PROPERTIES CAN BE INFLUENCED BY DRY RESIDUES OF CEREBROSPINAL FLUID OR BLOOD. DESPITE THIS, WE HAVE EXAMINED THE VALVE. BASED ON OUR INVESTIGATION RESULTS, WE CAN DETERMINE ADJUSTMENT DIFFICULTIES IN THE VALVE. THE DETERMINED DEPOSITS COULD BE NAMED AS THE CAUSE FOR THE ADJUSTMENT DIFFICULTIES. 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 2.0 (#FX410T) WAS IMPLANTED DURING A PROCEDURE PERFORMED IN (B)(6) 2022. ACCORDING TO THE COMPLAINANT, THE SHUNT SHOWED AN UNDER-DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINT DEVICE HAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 9 MONTHS. WEIGHT: 6.5 KILOGRAMS (KG). HEIGHT: 62 CENTIMETERS (CM). GENDER: UNKNOWN. SAME EVENT AS #3004721439-2023-00221.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695355 PROGAV 2.0 VALVE HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX410T 20061504 04041906136529

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Unknown Required Intervention