BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 WITH SHUNTASSISTANT 25

    MDR report key: 8349705 · Received February 19, 2019

    Report

    Report Number
    3004721439-2019-00031
    Event Type
    Injury
    Date Received
    February 19, 2019
    Date of Event
    January 22, 2019
    Report Date
    October 14, 2019
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO. KG
    Product Code
    JXG
    PMA / PMN Number
    K141687
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AESCULAP INC. (IMPORTER, REGISTRATION NO. 2916714) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN SURGICAL S.A. (MANUFACTURER, REGISTRATION NO. 3003639970). EXEMPTION NUMBER: E2014012 PLEASE PROVIDE PATIENT INFORMATION: GENDER, WEIGHT, PATIENT OUTCOME AND MEDICAL INTERVENTION. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    MANUFACTURING EVALUATION: THE SHUNT SYSTEM WAS RECEIVED SUBMERSED IN AN UNIDENTIFIED LIQUID IN A PLASTIC CONTAINER. VISUAL INSPECTION - NO SIGNIFICANT DEFORMATIONS OR DAMAGE OF THE VALVES WERE DETECTED DURING THE VISUAL INSPECTION. PERMEABILITY TEST - RESULTS HAVE SHOWN THAT THE SHUNT ASSISTANT HAS A BLOCKAGE AND THE PROGAV IS PERMEABLE. ADJUSTMENT TEST - THE PROGAV WAS TESTED AND IS ADJUSTABLE TO ALL SPECIFIED PRESSURES. BRAKING FORCE AND FUNCTION TEST - THE RESULTS HAVE SHOWN THAT THE BRAKE FUNCTION OPERATES AS EXPECTED. HOWEVER, THE BRAKING FORCE REQUIRED WAS NOT WITHIN THE SPECIFIED TOLERANCES. COMPUTER CONTROLLED TEST - THE PROGAV VALVE WAS NOT OPERATING WITHIN THE ACCEPTED TOLERANCE. THE MEASURED OPENING PRESSURE WAS LOWER THAN EXPECTED INDICATING A TENDENCY TOWARDS OVER-DRAINAGE. THE SHUNT ASSISTANT WAS UNABLE TO BE MEASURED DUE TO THE IDENTIFIED OCCLUSION. RESULTS - AFTER THE TESTS, WE HAVE DISMANTLED THE VALVES. INSIDE BOTH VALVES WE FOUND SIGNIFICANT BUILD-UP OF BLOODY SUBSTANCES (LIKELY PROTEIN). AS DESCRIBED IN OUR LITERATURE, THE PROBLEM ENCOUNTERED IS ONE OF THE KNOWN, INEVITABLE RISKS OF HYDROCEPHALUS (HC) - THERAPY BY SHUNT IMPLANTS. BASED ON OUR INVESTIGATION, WE ARE UNABLE TO SUBSTANTIATE THE CLAIM OF NON-ADJUSTABILITY. HOWEVER, IT CAN BE POSTULATED THAT THE OBSERVED DEPOSITS COULD ALSO HAVE TEMPORARILY COMPROMISED THE VALVE FUNCTIONALITY IN THE PAST. WE CAN EXCLUDE A DEFECT AT THE TIME OF RELEASE. THE SHUNT SYSTEM MET ALL SPECIFICATIONS OF THE FINAL INSPECTION WHEN RELEASED.

    Description of Event or Problem · 0

    "IT WAS REPORTED BY THE HEALTHCARE PROFESSIONAL "1Y 7M PO OVERDRAIN AND NOT ADJUSTABLE" . PATIENT: (B)(6) YEARS, DETAILS UNKNOWN. IMPLANTATION: (B)(6) 2017. REVISION: (B)(6) 2019. THE EXPLANTED PRODUCT WERE DELIVERED TO MIETHKE WITH THE RETURN KIT INSIDE AN UNKNOWN LIQUID. THE FILE WAS ENTERED WITH LIMITED INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142435 PROGAV 2.0 WITH SHUNTASSISTANT 25 HYDROCEPHALUS AND ICP MANAGEME JXG CHRISTOPH MIETHKE GMBH & CO. KG FX414T 20032142

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention