BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLARIS

    MDR report key: 5553665 · Received April 7, 2016

    Report

    Report Number
    3001587388-2015-15390
    Event Type
    Injury
    Date Received
    April 7, 2016
    Date of Event
    November 9, 2015
    Report Date
    November 9, 2015
    Manufacturer
    SOPHYSA
    Product Code
    JXG
    PMA / PMN Number
    K141227
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SOPHYSA HAS RECEIVED THE RETURNED PIECE AND THE PRODUCT IN QUESTION HAS BEEN EXAMINED ACCORDING TO OUR QUALITY CONTROL PROCEDURE: THE RETURNED VALVE WAS AT POSITION 2 (7 CM H2O), WHICH CONFORMS TO THE FINAL SETTING POSITION IN THE PATIENT. THE VISUAL CHECKING FOUND THAT THE VALVE PRESENTS A LOT OF DRY "CRYSTAL" DEPOSITS IN THE MECHANISM AROUND THE ROTOR. A SIPHON X (N° 202086) IS CONNECTED THE VALVE, SEVERAL IMPORTANT DRY DEPOSITS ARE VISIBLE INSIDE. A CATHETER OF 800MM IS RETURNED WITH THE VALVE, A SECOND ONE OF 15 MM IS CONNECTED BETWEEN THE VALVE AND THE SIPHON X AND A THIRD ONE OF 55 MM IS CONNECTED ON THE RESERVOIR. THE BALL IS FOUND STUCK ON THE INLET CONNECTOR. WE THAN USED A METALLIC STYLET TO UNSTUCK IT. THEN WE CARRIED OUT THE FUNCTION CHECKING. THE ROTATION TEST DIDN'T PASS AS THE ROTOR STUCK AT POSITION 2. IT WAS NOT ABLE TO CHANGE THE PRESSURE SETTING ON THE RETURNED VALVE. THE PRESSURE TESTING CONFORMS TO THE SPECIFICATION. THE PRESSURE CHARACTERS WERE THEN TESTED ON THE VALVE AND THE SIPHON X. THEY CONFORM TO THE PRESSURE SPECIFICATIONS EXCEPT A SLIGHT LOWER PRESSURE (189MMH2O COMPARED TO 190-215 TOLERANCE RANGE) AT HIGH PRESSURE SETTING (POSITION 5). THE PRESSURES AT 7 CM H2O AND 11 CM H2O THAT WERE USED BY THE PATIENT CONFORM TO THE SPECIFICATION. THE VALVE IS 100% CONTROLLED (PRESSURE/FLOW CHARACTERISTICS, VISUAL CONTROLS, ETC.) DURING THE MANUFACTURING. A REVIEW OF THE FABRICATION RECORD SHOWED NO ANOMALIES. THE ROOT CAUSE OF THE PROBLEM ENCOUNTERED COULD BE DUE TO THE BLOCKAGE OF THE BALL AND ROTOR CAUSED BY BIOLOGICAL DEBRIS. THE BLOCKAGE BY BIOLOGICAL DEBRIS IS A KNOWN SHORT AND LONG TERM ADVERSE EVENT AS DESCRIBED IN THE IFU. THIS IS AN INHERENT RISK TO ANY INTERNAL SHUNTING SYSTEM IRRESPECTIVE OF THE MANUFACTURER NOR OR THE MANUFACTURING PROCESS. FILE ATTACHMENTS. THE FOLLOW-UP REPORT WAS ORIGINALLY SUBMITTED IN APRIL 2016. AS REQUESTED BY THE FDA, THE FOLLOW-UP REPORT IS RESUBMITTED TO CORRECT/UPDATE THE FOLLOWING ITEMS: - MANUFACTURER CONTACT (SECTIONS D. 3. AND G. 1,2.). - TYPE OF REPORT (FOLLOW-UP #) (SECTION G 7.). - NON-HEALTHCARE PROFESSIONNAL FOR OCCUPATION (SECTION E. 3.). - MEDWATCH 3500A FORMAT WHICH HAS BEEN UPDATED SINCE 2016.

    Description of Event or Problem · 0

    THE VALVE WAS IMPLANTED IN (B)(6) 2015, BY V-P SHUNT. AT THAT TIME, THE PRESSURE WAS SET TO 11CM H2O, WHEN THE PATIENT ICP WAS 14CM H2O. AFTER 3 MONTH, THE PATIENT WAS RE-HOPITALIZATION, THE PRESSURE OF THE VALVE WAS TESTED AND IT SHOWED 20CM H2O, THE PRESSURE CHANGED AND THE RE-ADJUST TO 11CM H2O. AFTER 1 MONTH, THE PATIENT CHECKED THE CT SHOWED THE VENTRICULAR WAS NOT GOOD SO THE PRESSURE WAS SET TO 7 CM H2O. 20 DAYS LATER, THE PATIENT'S SITUATION WAS NOT GOOD AND THE VENTRICULAR SHOWED LARGER THAN FORMER AFTER CT SCAN. 2 DAYS LATER, THE PATIENT WAS SCANNED AGAIN BY CT AND SHOWED FISSURE VENTRICLE. DURING THIS PERIOD, THE VALVE'S PRESSURE WAS NOT CHANGED, STILL THE 7 CM H2O. THE DOCTOR SUSPECTS THE VALVE DOESN'T WORK SO HE TOOK OUT THE VALVE AND ASKED FOR A FUNCTION TEST OF THIS VALVE .

    Additional Manufacturer Narrative · 1

    WAITING THE RETURNING PIECE TO DO ANALYSIS.

    Description of Event or Problem · 1

    THE VALVE WAS IMPLANTED IN (B)(6) 2015, BY V-P SHUNT. AT THAT TIME, THE PRESSURE WAS SET TO 11CM H2O, WHEN THE PATIENT ICP WAS 14CM H2O. AFTER 3 MONTHS, THE PATIENT WAS RE-HOSPITALIZATION, THE PRESSURE OF THE VALVE WAS TESTED AND IT SHOWED 20CM H2O, THE PRESSURE CHANGED AND THE RE-ADJUST TO 11CM H2O. AFTER 1 MONTH, THE PATIENT CHECKED THE CT SHOWED THE VENTRICULAR WAS NOT GOOD SO THE PRESSURE WAS SET TO 7CM H2O. TWENTY DAYS LATER, THE PATIENT'S SITUATION WAS NOT GOOD AND THE VENTRICULAR SHOWED LARGER THAN FORMER AFTER CT SCAN. TWO DAYS LATER THE PATIENT WAS SCANNED AGAIN BY CT AND SHOWED FISSURE VENTRICLE. DURING THIS PERIOD, THE VALVE'S PRESSURE WAS NOT CHANGED, STILL THE 7CM H2O. THE DOCTOR SUSPECTS THE VALVE DOESN'T' WORK SO HE TOOK OUT THE VALVE AND ASKED FOR A FUNCTION TEST OF THIS VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212595 POLARIS ADJUSTABLE HYDROCEPHALUS SHUNT JXG SOPHYSA SPVA-2010 WITH ANTI-SIPHON DEVICE

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention