BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 3872125 · Received April 17, 2014

    Report

    Report Number
    2032546-2014-00009
    Event Type
    Injury
    Date Received
    April 17, 2014
    Date of Event
    February 19, 2014
    Report Date
    March 18, 2014
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    PMA / PMN Number
    P080030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS THAT RELATE TO THE REPORTED EVENT. IOP ELEVATION AND HYPHEMA ARE LISTED IN THE DEVICE LABELING AS KNOWN INHERENT RISK OF CATARACT AND GLAUCOMA STENT SURGERY. MFR REFERENCE #: (B)(4). SUBMITTED TO FDA ON 04/17/2014.

    Description of Event or Problem · 1

    THE SURGEON REPORTED PERFORMING UNEVENTFUL CATARACT SURGERY WITH IMPLANTATION OF THE ISTENT ON (B)(6) 2014 IN THE PATIENT'S LEFT EYE. AT THE ONE DAY POSTOPERATIVE VISIT, THE PATIENT PRESENTED WITH HYPHEMA AND ELEVATED INTRAOCULAR PRESSURE (IOP) IN THE OPERATIVE EYE. PREOPERATIVELY, THE PATIENT'S IOP WAS 18 MMHG. THE PATIENT WAS PRESCRIBED LUMIGAN TO HELP LOWER THE IOP AS HYPHEMA RESOLVES. AT THE PATIENT'S MOST RECENT VISIT ON (B)(6) 2014, THE PATIENT'S IOP DECREASED TO 16 MMHG AND THE PATIENT WAS LISTED AS STABLE AND HYPHEMA RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235049 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLAN OGO GLAUKOS CORPORATION GTS100L 102375

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention