BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 3963299 · Received May 28, 2014

    Report

    Report Number
    2032546-2014-00020
    Event Type
    Malfunction
    Date Received
    May 28, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 1, 2014
    Manufacturer
    GLAUKOS CORP.
    Product Code
    OGO
    PMA / PMN Number
    P080030
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PT AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. 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. DURING SURGERY, AN ATTEMPT WAS MADE TO PLACE THE STENT, HOWEVER, THE STENT WAS INADVERTENTLY PLACED IN THE CILIARY BODY AND WAS NOT RETRIEVABLE. THE SURGEON CONFERRED WITH THE GLAUKOS MED MONITOR AND SINCE THE STENT WAS NOT VISIBLE ON GONIOSCOPY, HE PLANS TO PERFORM A UBM ANALYSIS AND OBSERVE THE PT FOR NOW. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312889 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORP. GTS100L 102047

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR