BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 SYS W/ITH SA10 A.CONTROL RESERVOIR

    MDR report key: 21136966 · Received January 13, 2025

    Report

    Report Number
    3004721439-2024-00420
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    November 11, 2024
    Report Date
    February 24, 2025
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906137304
    PMA / PMN Number
    K161853
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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, NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE PROGAV 2.0 WAS DETERMINED. PERMEABILITY TEST: A PERMEABILITY TEST HAS INDICATED THAT THE VALVE HAS A BLOCKAGE. THE RESERVOIR WAS PERMEABLE AFTER SEPARATION OF COMPONENTS. 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. BECAUSE THE VALVE IS NOT PERMEABLE, A COMPUTER CONTROLLED TEST IS NOT POSSIBLE. ADJUSTMENT TEST: THE PROGAV 2.0 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 VALVE, DEPOSITS WERE FOUND IN. RESULT : IN ADVANCE, WE WOULD LIKE TO POINT OUT THAT THE PRODUCT WAS NOT SUBMERGED IN LIQUID AT THE TIME OF RETURN. THEREFORE, A MEANINGFUL ANALYSIS WITH CONCLUSIVE RESULTS IS NOT POSSIBLE. RETURNING PRODUCTS IN A DRY CONDITION CAN LEAD TO A CHANGE IN THE PRODUCT, WHICH CAN HAVE A NEGATIVE IMPACT ON FUNCTIONALITY. NEVERTHELESS, WE EXAMINED THE PRODUCT. BASED ON THE INVESTIGATION RESULTS, IT WAS DETERMINED THAT THE PROGAV 2.0 WAS NOT ADJUSTABLE AND CLOGGED. THE VISIBLE DRIED DEPOSITS COULD HAVE LED TO THE FUNCTIONAL DEVIATIONS. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROGAV 2.0 (#FX432T) WAS IMPLANTED DURING A PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. THE COMPLAINED PRODUCT WILL BE RETURNED TO THE MANUFACTURER FOR INVESTIGATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROGAV 2.0 (#FX432T) WAS IMPLANTED DURING A PROCEDURE ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT, THE SHUNT SYSTEM CAUSED AN UNDERDRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024. THE COMPLAINED PRODUCT WAS NOW RETURNED 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
    499533 PROGAV 2.0 SYS W/ITH SA10 A.CONTROL RESERVOIR HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX432T 20076219 04041906137304

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Male Required Intervention