BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROGAV 2.0 W/SA2.0 10 & PED.SPRUNG RES.

    MDR report key: 16910409 · Received May 11, 2023

    Report

    Report Number
    2916714-2023-00052
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    April 26, 2023
    Report Date
    June 9, 2023
    Manufacturer
    CHRISTOPH MIETHKE GMBH & CO KG
    Product Code
    JXG
    UDI-DI
    04041906502324
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    INVESTIGATION: VISUAL INSPECTION: THE FOLLOWING OBSERVATIONS WERE MADE DURING THE VISUAL INSPECTION: PIECE OF THIRD-PARTY CATHETER; DEPOSITS IN THE SPRUNG RESERVOIR. PERMEABILITY TEST: THE TEST SHOWED THAT THE PROGAV 2.0, THE SHUNTASSISTANT 2.0 AND THE SPRUNG RESERVOIR ARE 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 2,48 CMH2O. THIS IS WITHIN THE SPECIFIED TOLERANCE OF 3 CMH2O ± 3 CMH2O. 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 10 CMH2O IN THE VERTICAL POSITION, A PRESSURE OF 10 CMH2O +4/-2 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 12,98 CMH2O. THIS IS WITHIN THE SPECIFIED TOLERANCE OF 10 CMH2O +4/-2 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 4,56 CMH2O IS OPERATING NOT WITHIN THE SPECIFIED TOLERANCE (0 TO 4 CMH2O). ACCORDING TO OUR RESULTS, WE CAN DETECT A PRESENCE OF A SLOWED OUTFLOW IN THE HORIZONTAL POSITION OF THE SHUNTASSISTANT 2.0. ADJUSTABILITY TEST: THE PROGAV 2.0 WAS FOUND TO BE ADJUSTABLE TO ALL PRESSURE SETTINGS. THE SHUNTASSISTANT 2.0 IS A FIXED PRESSURE VALVE, THEREFORE THE ADJUSTABILITY TEST IS INAPPLICABLE. BRAKING FORCE AND BRAKE FUNCTION TEST: THE BRAKING FORCE OF THE PROGAV 2.0 WAS WITHIN THE SPECIFIED TOLERANCE AND THE BRAKE FUNCTION OPERATED AS EXPECTED. INTERNAL INSPECTION OF PRODUCT: AFTER DISMANTLING OF THE VALVES, DEPOSITS WERE FOUND IN BOTH VALVES. RESULTS: FOR THE SAKE OF THOROUGHNESS AND TRANSPARENCY, WE WOULD LIKE TO POINT OUT THAT AN ADJUSTMENT TEST AND PERMEABILITY TEST WAS ALREADY CARRIED OUT AFTER THE REVISION AT THE HOSPITAL. BASED ON OUR INVESTIGATION RESULTS, WE HAVE DETERMINED A SLOWER OUTFLOW IN THE HORIZONTAL POSITION OF THE SHUNTASSISTANT 2.0 AT THE TIME OF OUR INVESTIGATION. DETECTED DEPOSITS CAN BE NAMED AS THE CAUSE OF THE FUNCTIONAL DEVIATION. EXISTING DEPOSITS IN THE CSF CAN TEMPORARILY IMPAIR THE FUNCTION OF THE VALVE 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. NO FURTHER ACTIONS ARE REQUIRED FROM OUR POINT OF VIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED TO AESCULAP INC. THAT A PROGAV 2.0 W/SA2.0 10 & PED.SPRUNG RES. (PRODUCT # FX684T) WAS IMPLANTED ON (B)(6) 2023. ACCORDING TO THE COMPLAINANT THE VALVED APPEARED TO NOT BE DRAINING PER SURGEON'S ASSESSMENT ON (B)(6) 2023. THIS APPEARED TO ALLEVIATE THE SWELLING/FLUID BUILD UP AND ALLOWED THE VALVE TO DRAIN. IT WAS REPORTED THAT ON (B)(6) 2023 THE FLUID BUILD UP RETURNED. THE PATIENT UNDERWENT REVISION SURGERY ON (B)(6) 2023. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE REVISION SURGERY. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

    Description of Event or Problem · 0

    INVESTIGATION COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915355 PROGAV 2.0 W/SA2.0 10 & PED.SPRUNG RES. HYDROCEPHALUS MANAGEMENT JXG CHRISTOPH MIETHKE GMBH & CO KG FX684T 20053393 04041906502324

    Patients

    Seq Age Sex Outcome Treatment
    1 5 MO Unknown Required Intervention