BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GAV 2.0 W/PED.PRECHAMBER 5/25

    MDR report key: 23165766 · Received September 29, 2025

    Report

    Report Number
    3004721439-2025-00277
    Event Type
    Injury
    Date Received
    September 29, 2025
    Date of Event
    August 14, 2025
    Report Date
    October 13, 2025
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    PMA / PMN Number
    K190174
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: INVESTIGATION ON-GOING. SHOULD RELEVANT ADDITIONAL INFORMATION / INVESTIGATION RESULTS BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: DURING THE INVESTIGATION, DEPOSITS IN THE PED. PRECHAMBER WERE DETERMINED. 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 VALVE IS TESTED IN BOTH THE HORIZONTAL AS WELL AS THE VERTICAL POSITIONS. THE RESULTS SHOW THAT THE VALVE DOES NOT OPERATE WITHIN THE ACCEPTED TOLERANCE IN VERTICAL POSITION. AN ACCELERATED OUTFLOW OF GAV 2.0 COULD BE DETERMINED. INTERNAL INSPECTION: AFTER DISMANTLING OF THE VALVE, DEPOSITS WERE FOUND IN GAV 2.0 AND THE PED. PRECHAMBER. RESULTS: ACCORDING TO THE RESULTS OF THE INVESTIGATION, AN ACCELERATED OUTFLOW AT THE GAV 2.0 IN THE VERTICAL POSITION WAS DETECTED. THE VISIBLE DEPOSITS HAVE LED TO THE FUNCTIONAL DEVIATION. FURTHERMORE, WE CAN DETERMINE VISIBLE DEPOSITS IN THE PED. PRECHAMBER. THE DEPOSITS HAD NO EFFECT UPON THE SPECIFICATIONS AT THE TIME OF THE EXAMINATION. THE PRECHAMBER OPERATED WITHIN ALL SPECIFICATIONS. DEPOSITS CAUSED BY SUBSTANCES NATURALLY PRESENT IN THE PATIENT'S 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 ORGANIC MATERIAL CAN AFFECT THE INTEGRITY OF THE VALVE. THE EXAMINATION OF THE RETURN HAS BEEN COMPLETED WITH THE DRAFTING OF THIS REPORT. 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 GAV 2.0 (#61920525) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT, THE VALVE CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 202508/14/2025. THE COMPLAINED PRODUCT WILL BE SEND TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1395777 GAV 2.0 W/PED.PRECHAMBER 5/25 HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG MIETHKE-61920525 20060569

    Patients

    Seq Age Sex Outcome Treatment
    1 6 MO Male Required Intervention