BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 4092640 · Received August 19, 2014

    Report

    Report Number
    2032546-2014-00032
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 21, 2014
    Manufacturer
    GLAUKOS CORP.
    Product Code
    OGO
    PMA / PMN Number
    P080030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PT AND IS NOT AVAILABLE FOR EVAL. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO ISSUES FOUND. STENT MALPOSITION IS LISTED IN THE DEVICE LABELING AS A KNOWN INHERENT RISK OF GLAUCOMA STENT SURGERY. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED PERFORMING CATARACT SURGERY WITH IMPLANTATION OF THE ISTENT IN THE PT'S LEFT EYE. DURING SURGERY A CYCLODIALYSIS CLEFT WAS CREATED INADVERTENTLY AND THE STENT BECAME LOST IN THE CLEFT. NO INTERVENTION WAS PERFORMED AND POSTOPERATIVELY THE PT HAD GOOD VISUAL ACUITY AND GOOD IOP CONTROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496844 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWEING IMPLAN OGO GLAUKOS CORP. GTS100L 102816

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR