BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 3902825 · Received February 20, 2014

    Report

    Report Number
    2032546-2014-00004
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    December 19, 2013
    Report Date
    January 23, 2014
    Manufacturer
    GLAUKOS CORP.
    Product Code
    OGO
    PMA / PMN Number
    P080030
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS RELATED TO THE REPORTED ISSUE OF THE STENT BEING MALPOSITIONED. 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 PERFORMING SURGERY WITH IMPLANTATION OF THE ISTENT. POSTOPERATIVELY, THE PT DID NOT HAVE THE IOP LOWERING EFFECT THAT WAS EXPECTED SO THE SURGEON PERFORMED GONIOSCOPY AND OBSERVED THAT THE STENT WAS SEATED IN THE CILIARY BASE, NOT IN SCHLEMM'S CANAL. THE EYE WAS QUEST AND THE PT WAS PUT BACK ON GLAUCOMA MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107694 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORP. GTS100L 101994

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR