BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EX-PRESS MINI GLAUCOMA SHUNT

    MDR report key: 3940275 · Received June 19, 2014

    Report

    Report Number
    3003701944-2014-00089
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    March 1, 2014
    Report Date
    May 23, 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
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED BY A COMPANY REP AND IS IN TRANSIT TO THE MFR SITE FOR INVESTIGATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED THAT APPROXIMATELY EIGHTEEN MONTHS AFTER A GLAUCOMA FILTERING DEVICE WAS IMPLANTED, THE PT HAD INCREASED INTRAOCULAR PRESSURE. IN A FOLLOW UP, THE SURGEON REPORTED THAT ALTHOUGH THE PT WAS PRESCRIBED MEDICINE, PERFORMED EYE MASSAGES, PREVIOUSLY HAD A SUTURE LYSED, AND A RECENT NEEDING PROCEDURE PERFORMED, THE INTRAOCULAR PRESSURE REMAINED AT AN INCREASED LEVEL. THE PT WAS ADMITTED INTO THE HOSPITAL FOR ONE MONTH. DURING THE HOSPITAL STAY, THE SURGEON LIFTED THE FLAP OVER THE SHUNT AND CONFIRMED THAT THERE WAS MINIMAL FLOW OF AQUEOUS HUMOR AND THE SHUNT WAS GETTING CLOGGED. A WEEK LATER, THE SHUNT WAS REMOVED AND A TRABECULECTOMY WAS COMPLETED. THE SURGEON EXPLAINED THAT HE THOUGHT A BACKFLOW OF BLOOD CAUSED BY THE EYE MESSAGES WAS ASSOCIATED WITH CAUSING THE SHUNT TO CLOG. THE SURGEON REPORTED THAT THE PT IS RECOVERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360389 EX-PRESS MINI GLAUCOMA SHUNT AQUEOUS SHUNT KYF OPTONOL, LTD P-50 PL UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R