BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 4132071 · Received September 24, 2014

    Report

    Report Number
    2032546-2014-00037
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 28, 2014
    Report Date
    August 28, 2014
    Manufacturer
    GLAUKOS CORP.
    Product Code
    OGO
    PMA / PMN Number
    P080030
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED STENT IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO ISSUES FOUND. STENT DISLOCATION AND HYPHEMA ARE LISTED IN THE DEVICE LABELING AS KNOWN INHERENT RISKS 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 RIGHT EYE. DURING SURGERY IT REQUIRED TWO ATTEMPTS TO INSERT THE STENT BECAUSE THE FIRST ATTEMPT WAS TOO POSTERIOR. ONE DAY POSTOPERATIVELY, THE PATIENT PRESENTED WITH HYPHEMA. AT THE POSTOPERATIVE VISIT ON (B)(6) 2014, THE HYPHEMA HAD CLEARED; HOWEVER, THE STENT HAD DISLODGED AND WAS SITTING IN THE INFERIOR ANGLE. THE STENT DISLOCATION WAS THOUGHT TO BE CAUSED BY SNEEZING. ON (B)(6) 2014 THE STENT WAS EXPLANTED AND THE PATIENT'S CURRENT STATUS IS REPORTED AS "DOING WELL".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593800 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLAN OGO GLAUKOS CORP. GTS100L 103110

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention