BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 4008694 · Received July 22, 2014

    Report

    Report Number
    3003701944-2014-00120
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    April 1, 2014
    Report Date
    April 24, 2014
    Manufacturer
    OPTONOL, LTD
    Product Code
    KYF
    PMA / PMN Number
    K030350
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE SHUNT WAS RETURNED FOR INVESTIGATION. THE SHUNT WAS FOUND TO BE INTACT AND THE SHUNTS' LUMEN WAS FOUND TO BE OPEN. THEREFORE THE COMPLAINT "FAILED" CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD (DHR) FOR THE BATCH WAS REVIEWED. NO ABNORMALITIES WERE FOUND DURING THE DHR REVIEW AND THE PRODUCT WAS MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RECEIVED. (B)(4). THIS REPORT WAS MAILED TO FDA ON: 07/30/2014. (B)(4).

    Description of Event or Problem · 1

    AN OFFICE ADMINISTRATOR REPORTED THAT FOLLOWING A GLAUCOMA FILTRATION DEVICE (GFD) IMPLANT PROCEDURE THAT THE GFD FAILED. THE GFD WAS IMPLANTED FOR 1-2 WEEKS AND IT WAS REMOVED BECAUSE THE PATIENT CONTINUED TO HAVE HIGH INTRAOCULAR PRESSURE (IOP). UPON REMOVING THE DEVICE THE SURGEON TRIED TO IRRIGATE THE GFD BUT HE COULD NOT FLUSH THROUGH IT. THE SURGEON WAS CONCERNED THA THE GFD WAS OBSTRUCTED WHICH MAY HAVE BEEN THE REASON THAT THE PATIENT CONTINUED TO HAVE HIGH IOP. HE IS NOT POSITIVE IF THE DEVICE WAS OBSTRUCTED OR IF THIS WAS JUST COINCIDENTAL. THE GFD WAS REPLACED WITH DIFFERENT GFD. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427839 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL 132627

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention