BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 3871929 · Received April 17, 2014

    Report

    Report Number
    2032546-2014-00010
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Date of Event
    March 20, 2014
    Report Date
    March 20, 2014
    Manufacturer
    GLAUKOS CORP.
    Product Code
    OGO
    PMA / PMN Number
    P080030
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IN THE PT AND IS NOT AVAILABLE FOR EVAL. THE DEVICE IDENTIFIERS HAVE BEEN REQUESTED. 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 THAT THE ISTENT WAS IMPLANTED SUPERFICIALLY. WHEN THE SURGEON WENT TO REGRASP THE STENT AFTER CLEARING THE BLOOD, THE STENT WAS NOT THERE, PRESUMABLY LOST IN THE IATROGENICALLY RECESSED ANGLE. NO PT INJURY WAS REPORTED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236846 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK