BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 WITH SHUNTASSISTANT 20

    MDR report key: 16390193 · Received February 16, 2023

    Report

    Report Number
    3004721439-2023-00022
    Event Type
    Injury
    Date Received
    February 16, 2023
    Date of Event
    January 17, 2023
    Report Date
    March 31, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906136550
    PMA / PMN Number
    K161853
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION - D9. INVESTIGATION: VISUAL INSPECTION: THE FOLLOWING OBSERVATIONS WERE MADE DURING THE VISUAL INSPECTION: DAMAGE OF THE OUTER HOUSING OF THE PROGAV 2.0 , THIRD-PARTY CATHETER. PERMEABILITY TEST: THE PERMEABILITY TEST WAS PERFORMED AT A HYDROSTATIC PRESSURE DIFFERENCE OF THE PRESSURE SETTING OF THE PROGAV® 2.0 SHUNT SYSTEM UPON RECEIPT PLUS 30 CMH2O IN THE HORIZONTAL DIRECTION OF FLOW. THE TEST SHOWED THAT THE PROGAV 2.0 SHUNT SYSTEM IS PERMEABLE. COMPUTER CONTROL TEST: TO CHECK THE FLOW RATE OF THE VALVES, THE VALVES WERE TESTED ON A MIETHKE COMPUTER- CONTROLLED TESTING APPARATUS AND PASSED THE STANDARD TEST. THE FLOW OF THE TEST LIQUID WAS REDUCED STEP BY STEP FROM 60 ML/H TO 5 ML/H (IN ACCORDANCE WITH ISO 7197). DISTILLED WATER WAS USED AS THE TEST-LIQUID. THE RESULTING PRESSURE WAS MEASURED. THE COMPUTER - CONTROLLED TEST SHOWED THE OPENING PRESSURE OF THE PROGAV 2.0, AT A REFERENCE FLOW RATE OF 20 ML/H IN A HORIZONTAL POSITION OF THE VALVE, TO BE 4,81 CMH2O. THIS IS NOT WITHIN THE SPECIFIED TOLERANCE OF 11 CMH2O ± 3 CMH2O. AN APPLIED PRESSURE OF 11 CMH2O, WITH THE DEVICE IN THE HORIZONTAL POSITION IS EXPECTED TO HAVE A RESULTANT PRESSURE OF 11 CMH2O ± 3 CMH2O. ACCORDING TO OUR RESULTS, WE CAN DETECT AN ACCELERATED OUTFLOW. ADDITIONALLY, THE SHUNTASSISTANT WAS TESTED ACCORDING TO STANDARD PROCEDURE IN THE VERTICAL POSITION OF THE VALVE. AT A FIXED OPENING PRESSURE OF 20 CMH2O IN THE VERTICAL POSITION, A PRESSURE OF 20 CMH2O +4/-2 CMH2O IS EXPECTED. THE RESULTS INDICATED THAT AT A REFERENCE FLOW OF 20 ML/H IN THE VERTICAL POSITION, THE SHUNTASSISTANT HAD A PRESSURE OF 5,56 CMH2O. THIS IS NOT WITHIN THE SPECIFIED TOLERANCE OF 20 CMH2O +4/-2 CMH2O. ACCORDING TO OUR RESULTS, WE CAN DETECT AN ACCELERATED OUTFLOW. ADJUSTABILITY TEST: THE PROGAV 2.0 WAS FOUND TO BE NON-ADJUSTABLE WITHIN THE SPECIFIED RANGE. THE SHUNTASSISTANT IS A FIXED PRESSURE VALVE, THEREFORE THE ADJUSTABILITY TEST IS INAPPLICABLE. BRAKING FORCE AND BRAKE FUNCTION TEST: THE BRAKING FORCE TEST INDICATES THAT THE BRAKE FUNCTION OF THE PROGAV 2.0 IS PRESENT. DUE TO THE NON-ADJUSTABILITY OF THE VALVE, AS DETAILED IN SECTION ADJUSTABILITY TEST, AN INVESTIGATION OF THE BRAKING FORCE WAS NOT POSSIBLE. INTERNAL INSPECTION OF PRODUCT: AFTER DISMANTLING OF THE VALVES, DEPOSITS WERE FOUND IN BOTH VALVES. RESULTS: BASED ON OUR INVESTIGATION RESULTS, WE HAVE DETERMINED AN ACCELERATED OUTFLOW IN THE SHUNT SYSTEM AND A NON - ADJUSTABILITY IN THE PROGAV 2.0 AT THE TIME OF OUR INVESTIGATION. DETECTED DEPOSITS COULD BE NAMED AS THE CAUSE OF THE FUNCTIONAL DEVIATION. ENDOGENOUS SUBSTANCES IN THE CSF CAN TEMPORARILY IMPAIR THE FUNCTION OF THE VALVES AND IS DESCRIBED AS CONCOMITANT SYMPTOMS IN HYDROCEPHALUS THERAPY. 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.

    Additional Manufacturer Narrative · 0

    MANUFACTURING SITE EVALUATION: NO PRODUCT RECEIVED TO DATE. SHOULD RELEVANT ADDITIONAL INFORMATION/INVESTIGATION RESULTS BECOME AVAILABLE, AN ADDITIONAL MEDWATCH REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PROGAV 2.0 SHUNT SYSTEM (PART # FX413T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, THE SYSTEM WAS BELIEVED TO BE OPERATED IN UNDER-DRAINAG, BLOCKED, ADJUSTMENT DIFFICULTIES. THE PATIENT UNDERWENT A REVISION PROCEDURE PERFORMED ON (B)(6) 2023. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. AGE: 3 YEARS. HEIGHT: 104 CENTIMETERS (CM). WEIGHT: 16 KILOGRAMS (KG). GENDER: MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354422 PROGAV 2.0 WITH SHUNTASSISTANT 20 HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX413T 20051573 04041906136550

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Male Required Intervention