BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 3072531 · Received April 18, 2013

    Report

    Report Number
    2032546-2013-00002
    Event Type
    Malfunction
    Date Received
    April 18, 2013
    Date of Event
    March 1, 2013
    Report Date
    March 21, 2013
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    PMA / PMN Number
    P080030
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L INFO HAS BEEN REQUESTED, HOWEVER, AT THIS TIME NO DEVICE IDENTIFIER HAS BEEN PROVIDED AND THE DEVICE REMAINS IMPLANTED IN THE PT. IF ADD'L INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT A STENT BECAME DISLODGED AT THE ONE-DAY POSTOPERATIVE VISIT. ON GONIOSCOPY AT THE SLIT LAMP THE STENT WAS VISIBLE SITTING IN THE INFERIOR CHAMBER ANGLE. THE SURGEON STATED THAT THE STENT APPEARED TO BE PROPERLY PLACED IN THE CANAL OF SCHLEMM AT THE TIME OF SURGERY. POSTOPERATIVELY, THE PT IS HEALING WELL, IOP IS CONTROLLED, AND THE CORNEA APPEARED FINE AND THE PT IS UNDER OBSERVATION. ADD'L F/U HAS BEEN REQUESTED IN ORDER TO DETERMINE WHETHER INTERVENTION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167857 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION GTS100L UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK