BEUDAMED
    FDA Adverse Event Death Summary report: N

    POLARIS

    MDR report key: 6954345 · Received October 17, 2017

    Report

    Report Number
    3001587388-2017-17421
    Event Type
    Death
    Date Received
    October 17, 2017
    Date of Event
    July 20, 2017
    Report Date
    December 21, 2017
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    PMA / PMN Number
    K031097
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED TO OUR FACILITY AND ANALYZED FOLLOWING OUR QUALITY CONTROL PROCEDURE. THE PRODUCT WAS RETURNED IN A DRY STATE, DESPITE THE RECOMMENDATION GIVEN IN THE IFU TO RETURN THE DEVICE IN STERILE WATER. VISUAL EXAMINATION: IMPORTANT VISCOUS DEPOSITS ARE OBSERVED INSIDE THE INNER MECHANISM OF THE VALVE, WITH SOME LIQUID INSIDE THE VALVE. THIS COULD EXPLAIN THE DIFFICULTIES OBSERVED BY THE USER WHEN TRYING TO ADJUST THE VALVE. FUNCTIONAL CONTROL: THE VALVE IS BLOCKED BECAUSE THE BALL IS STUCK ON ITS SEAT. THIS COULD BE EXPLAINED BY THE FACT THAT THE DEVICE WAS RETURNED IN A DRIED STATE. THE PRESSURE CAN HOWEVER STILL BE ADJUSTED, UPON RETURN AND AFTER CLEANING. SOME RESIDUAL DEPOSITS ARE OBSERVED INSIDE THE VALVE AFTER CLEANING, MAKING IT IMPOSSIBLE TO MEASURE THE PRESSURES. IN CONCLUSION, THE VISCOUS DEPOSITS COULD EXPLAIN THE DIFFICULTIES TO ADJUST THE VALVE, BUT THE ROTATION OF THE INNER MECHANISM REMAINS POSSIBLE. ANYWAY, THE STATE OF RETURN OF THE RETURN MAKES IT IMPOSSIBLE TO DRAW AN AFFIRMATIVE CONCLUSION REGARDING THE SITUATION FACED BY THE USER. THE VALVE IS 100% CONTROLLED (PRESSURE/FLOW CHARACTERISTICS, VISUAL CONTROLS, ETC.) DURING THE MANUFACTURING. A REVIEW OF THE FABRICATION RECORD SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    A (B)(6) YEARS-OLD FEMALE PATIENT WAS IMPLANTED WITH A LUMBO-PERITONEAL DERIVATION ON (B)(6) 2017. AFTER IMPLANTATION, THE OPERATING PRESSURE COULD NOT BE ADJUSTED. ON (B)(6) 2017, THE VALVE WAS REMOVED FROM THE PATIENT DUE TO INADEQUATE DRAINAGE. THE PATIENT PASSED AWAY TWO DAYS LATER DUE TO MENINGITIS. THE DOCTOR STATES THAT THERE WAS NO CAUSAL RELATION BETWEEN THE VALVE AND THE MENINGITIS THAT CAUSED THE PATIENT'S DEATH. SEVERAL UNCERTAINTIES SURROUND THIS CASE; ADDITIONAL INVESTIGATIONS WILL BE CARRIED OUT TO OBTAIN ADDITIONAL INFORMATION FROM THE INITIAL REPORTER.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT WAS IMPLANTED WITH A LUMBO-PERITONEAL DERIVATION ON (B)(6) 2017. AFTER IMPLANTATION, THE OPERATING PRESSURE COULD NOT BE ADJUSTED. ON (B)(6) 2017, THE VALVE WAS REMOVED FROM THE PATIENT DUE TO INADEQUATE DRAINAGE. THE PATIENT PASSED AWAY TWO DAYS LATER DUE TO MENINGITIS. THE DOCTOR STATES THAT THERE WAS NO CAUSAL RELATION BETWEEN THE VALVE AND THE MENINGITIS THAT CAUSED THE PATIENT'S DEATH. SEVERAL UNCERTAINTIES SURROUND THIS CASE; ADDITIONAL INVESTIGATIONS WILL BE CARRIED OUT TO OBTAIN ADDITIONAL INFORMATION FROM THE INITIAL REPORTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736211 POLARIS POLARIS ADJUSTABLE VALVE JXG SOPHYSA SPVA D0662

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death| R