BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 6190732 · Received December 20, 2016

    Report

    Report Number
    2032546-2016-00075
    Event Type
    Injury
    Date Received
    December 20, 2016
    Date of Event
    November 30, 2016
    Report Date
    January 10, 2017
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    UDI-DI
    00853704002012
    PMA / PMN Number
    P080030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS PENDING EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO NON-CONFORMITIES BELIEVED TO BE RELATED TO THE REPORTED EVENT. IRIS DAMAGE IS IDENTIFIED IN THE DEVICE LABELING AS A KNOWN INHERENT RISK OF GLAUCOMA STENT SURGERY. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION COMPLETED ON (B)(6) 2017: NO NONCONFORMITIES WERE OBSERVED DURING THE EVALUATION OF THE FORM, FIT, AND FUNCTION OF THE INSERTER. FURTHERMORE, MICROSCOPIC EXAMINATION OF THE STENT OBSERVED THAT THE STENT TIP DIMENSION WAS WITHIN SPECIFICATION. MFR REFERENCE #(B)(4).

    Description of Event or Problem · 1

    THE SURGEON REPORTED THAT DURING ATTEMPT AT ISTENT IMPLANTATION VISUALIZATION WAS COMPROMISED SO THE SURGEON DECIDED TO ABORT THE PROCEDURE. WHEN REMOVING THE DEVICE FROM THE PATIENT'S EYE THE PATIENT MOVED AND THE ISTENT TORE THE IRIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839963 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION GTS100L 107844 00853704002012

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other