BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 4987863 · Received August 5, 2015

    Report

    Report Number
    2032546-2015-00036
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 9, 2015
    Report Date
    July 9, 2015
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    PMA / PMN Number
    P080030
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    1

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE ISTENT AND INSERTER WERE RETURNED TO GLAUKOS AND DECONTAMINATED PRIOR TO EVALUATION. THE DEVICE WAS RECEIVED WITH THE STENT RE-GRASPED IN THE INSERTER. THE INSERTER WAS VISUALLY INSPECTED AND MET SPECIFICATIONS. THE STENT WAS INSPECTED MICROSCOPICALLY AND FOUND TO MEET DIMENSIONAL SPECIFICATIONS FOR STENT TIP SHARPNESS. FUNCTIONAL/PERFORMANCE TESTING WAS PERFORMED AND THE STENT AND INSERTER FUNCTIONED AS INTENDED. (B)(4). SUBMITTED TO FDA ON 09/23/2015.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED STENT HAS BEEN RETURNED TO GLAUKOS AND IS IN THE PROCESS OF BEING DECONTAMINATED. ONCE THE DEVICE HAS BEEN EVALUATED, THE FINDINGS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO ISSUES FOUND THAT RELATE TO THE REPORTED EVENT. STENT DISLOCATION IS LISTED IN THE DEVICE LABELING AS AN INHERENT RISK OF GLAUCOMA STENT SURGERY. (B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTS THAT THE ISTENT DISLODGED POSTOPERATIVELY. SECONDARY SURGICAL INTERVENTION WAS PERFORMED TO REMOVE THE DISLODGED STENT AND REPLACE IT WITH A NEW ISTENT. THE PATIENT IS DOING WELL. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515606 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLAN OGO GLAUKOS CORPORATION GTS100L 103706

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention