BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 SYS SA2.0 20 & PED.PRECHAMBER

    MDR report key: 11664356 · Received April 14, 2021

    Report

    Report Number
    3004721439-2021-00082
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    December 17, 2020
    Report Date
    May 25, 2021
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906503536
    PMA / PMN Number
    K190174
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    VISUAL INSPECTION: IN THE FIRST STEP OF OUR INVESTIGATION, WE PERFORMED A VISUAL INSPECTION OF THE PRODUCT. WE HAVE CHECKED FOR POSSIBLE DAMAGE, DEFORMATION OF THE HOUSING, DEPOSITS OR OTHER ABNORMALITIES. THE FOLLOWING OBSERVATIONS WERE MADE DURING THE VISUAL INSPECTION: TISSUE RESIDUES INSIDE THE RESERVOIR. 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 2,32 CMH2O. THIS IS NOT WITHIN THE SPECIFIED TOLERANCE OF 20 CMH2O ± 3 CMH2O. AN APPLIED PRESSURE OF 20 CMH2O, WITH THE DEVICE IN THE HORIZONTAL POSITION IS EXPECTED TO HAVE A RESULTANT PRESSURE OF 20 CMH2O ± 3 CMH2O. ADDITIONAL TESTING DID NOT SIGNIFICANTLY CHANGE THE RESULTS. ACCORDING TO OUR RESULTS, WE CAN CONFIRM THE PRESENCE OF A ACCELERATED OUTFLOW. ADDITIONALLY, THE SHUNTASSISTANT® 2.0 WAS TESTED ACCORDING TO STANDARD PROCEDURE IN THE HORIZONTAL AND VERTICAL POSITION OF THE VALVE. AT A FIXED OPENING PRESSURE OF 20 CMH2O IN THE VERTICAL POSITION, A PRESSURE OF 20 CMH2O -2/+4 CMH2O IS EXPECTED. THE RESULTS INDICATED THAT AT A REFERENCE FLOW OF 20 ML/H IN THE VERTICAL POSITION, THE SHUNTASSISTANT® 2.0 HAD A PRESSURE OF 19,23 CMH2O. THIS IS WITHIN THE SPECIFIED TOLERANCE OF 20 CMH2O -2/+4 CMH2O. THE TEST, PERFORMED IN THE HORIZONTAL POSITION OF THE VALVE AT A REFERENCE FLOW OF 20 ML/H SHOWED THAT THE SHUNTASSISTANT® 2.0 WITH A RESULT OF - 1,41 CMH2O IS OPERATING WITHIN THE SPECIFIED TOLERANCE (0 CMH2O ± 4CMH2O). ADJUSTABILITY TEST: IN THIS STEP, IT WAS INVESTIGATED WHETHER THE ADJUSTABLE PROGAV 2.0 CAN BE SUCCESSFULLY SET TO EACH SPECIFIED PRESSURE SETTING. IT WAS CHECKED WHETHER THE VALVE IS FULLY ADJUSTABLE WITHIN : THE FULL RANGE OF SPECIFIED PRESSURE SETTINGS ( IN INCREMENTS OF 5 CMH2O). THE PROGAV® 2.0 WAS FOUND TO BE ADJUSTABLE TO ALL PRESSURE SETTINGS. BRAKING FORCE AND BRAKE FUNCTION TEST: THE BRAKING FORCE AND BRAKE FUNCTION TEST INVESTIGATES WHETHER THE BRAKE FUNCTION OF THE ADJUSTABLE VALVES IS PRESENT AND HOW MUCH FORCE MUST BE EXERTED ON THE HOUSING TO RELEASE THE ROTOR TO ADJUST THE VALVES USING THE INTEGRATED MAGNET OF A SPECIFIC MEASUREMENT APPARATUS OF BRAKING FORCE. THE BRAKING FORCE OF THE PROGAV® 2.0 WAS WITHIN THE SPECIFIED TOLERANCE AND THE BRAKE FUNCTION OPERATED AS EXPECTED. INTERNAL INSPECTION OF PRODUCT: IN ORDER TO VERIFY WHETHER THE INVESTIGATED SHUNT SYSTEM WAS COMPROMISED BY THE KNOWN RISKS OF HYDROCEPHALUS THERAPY, E.G. BY A BUILD-UP OF NATURAL SUBSTANCES (PROTEIN, BLOOD, OR TISSUE PARTICLES) IN THE CEREBROSPINAL FLUID, WE HAVE DISMANTLED THE SHUNT SYSTEM. AFTER DISMANTLING OF THE VALVES, SOME DEPOSITS WERE FOUND IN PROGAV® 2.0. RESULTS: BASED ON OUR INVESTIGATION RESULTS, WE CAN IDENTIFY A ACCELERATED OUTFLOW IN THE PROGAV® 2.0 VALVE. WE ARE ASSUMING THAT THE DEPOSITS DETECTED WITHIN THE VALVE HAVE CAUSED THE FUNCTIONAL IMPAIRMENT. DEPOSITS CAUSED BY NATURAL SUBSTANCES IN THE CEREBROSPINAL FLUID, SUCH AS PROTEIN, BLOOD OR TISSUE PARTICLES, ARE AMONG THE KNOWN AND UNAVOIDABLE RISKS AND SIDE EFFECTS OF HYDROCEPHALUS THERAPY. SMALL AMOUNTS OF NON-VISIBLE DEPOSITS/PROTEINS MIGHT COMPROMISE THE INTEGRITY OF THE VALVE. 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.

    Description of Event or Problem · 0

    INVESTIGATION IS DONE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION ON- GOING. ADDITIONAL INFORMATION/ INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PROGAV 2.0 SHUNTSYSTEM (#FX596T) WAS IMPLANTED DURING A PROCEDURE PERFORMED ON (B)(6) 2020. ACCORDING TO THE COMPLAINANT, THE PROGAV 2.0 WAS BELIEVED TO BE NOT ADJUSTABLE IN THE PRESSURE SETTINGS AND OPERATED IN UNDER- DRAINAGE. THE PATIENT UNDERWENT A REVISION PROCEDURE. THE LATE NOTIFICATION IS DUE TO THE LATE INFORMATION ABOUT THE INCIDENT. THE COMPLAINANT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION PROCEDURE. PATIENT INFORMATION: AGE: (B)(6) YEARS, HEIGHT: 178 CM, WEIGHT: (B)(6) KG, GENDER: MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    563697 PROGAV 2.0 SYS SA2.0 20 & PED.PRECHAMBER HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX596T 20047665 04041906503536

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention