BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 6190472 · Received December 20, 2016

    Report

    Report Number
    2032546-2016-00074
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    October 26, 2016
    Report Date
    December 20, 2016
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    PMA / PMN Number
    P080030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE IDENTIFIERS WERE NOT AVAILABLE. HYPHEMA, IOP ELEVATION, DECREASED VISION, STENT MALPOSITIONING AND INFLAMMATION ARE IDENTIFIED IN THE DEVICE LABELING AS KNOWN INHERENT RISKS OF GLAUCOMA STENT SURGERY. (B)(4).

    Description of Event or Problem · 1

    CATARACT SURGERY WITH ISTENT IMPLANTATION WAS UNEVENTFUL. ON (B)(6) 2016 THE PATIENT PRESENTED WITH INTRAOCULAR INFLAMMATION REMAINING/ARISING AFTER THE STANDARD POSTOPERATIVE MEDICATION REGIMEN WAS COMPLETED. POST-OPERATIVE IMAGING REVEALED THAT THE STENT WAS MALPOSITIONED (STENT¿S SNORKEL IN CONTACT WITH IRIS) RESULTING IN ELEVATED IOP (30 MM HG) AND BLURRY VISION WHICH WAS TREATED WITH MEDICAL INTERVENTION. THE EYE WAS NOT CULTURED. THE INFLAMMATION WAS ALSO TREATED WITH MEDICAL INTERVENTION. THE PATIENT PRESENTED ON (B)(6) 2016 WITH ANOTHER EPISODE OF ELEVATED IOP AND BLURRY VISION AND RESOLVED WITH MEDICAL INTERVENTION AS WELL. AT THE TIME OF INITIAL POSTOPERATIVE IOP ELEVATION THE PATIENT WAS NOT ON ANY MEDICATIONS (IOP HAD BEEN IN LOW TEENS WITHOUT MEDICATION FOR OVER ONE YEAR AFTER INITIAL POST-OPERATIVE PERIOD). THE IOP INCREASE RESULTED IN CORNEAL EDEMA AND TRANSIENT DECREASED VISION (NOW RESOLVED). IN THE SURGEON'S OPINION THE PRIMARY REASON FOR THE IOP RISE WAS DUE TO HYPHEMA AND MALPOSITIONED ISTENT. BOTH EPISODES RESPONDED TO MEDICAL MANAGEMENT. THE SECOND EPISODE REQUIRED MORE MEDICATIONS THAT THE FIRST EPISODE. THE HYPHEMA WAS TREATED WITH STEROIDS AND IOP LOWERING DROPS. THE PATIENT WAS NOT TAKING ANY ANTI-COAGULANT MEDICATIONS PRE-OPERATIVELY OR POSTOPERATIVELY. THE PATIENT¿S IOP IS STABLE ON MEDICATIONS. ADVERSE EVENT WAS REPORTED TO HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841952 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION GTS100R

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention