BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 6097139 · Received November 11, 2016

    Report

    Report Number
    2032546-2016-00069
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    September 6, 2016
    Report Date
    September 12, 2016
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    UDI-DI
    00853704002005
    PMA / PMN Number
    P080030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS LOST BY THE CUSTOMER AND IS NOT AVAILABLE FOR 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. HYPHEMA, IOP ELEVATION, DECREASED VISION, AND INFLAMMATION ARE IDENTIFIED IN THE DEVICE LABELING AS KNOWN INHERENT RISKS OF GLAUCOMA STENT SURGERY. (B)(4). SUBMITTED TO FDA: 11/11/2016.

    Description of Event or Problem · 1

    THE SURGEON INITIALLY REPORTED BEING UNABLE TO IMPLANT THE ISTENT DUE TO PATIENT ANATOMY THAT PRECLUDED IMPLANTATION. CLINICAL FOLLOW-UP WAS REQUESTED AND ON (B)(6) 2016 THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL EVENT DETAILS. IMPLANTATION WAS NOT SUCCESSFUL DUE TO COMPROMISED VISUALIZATION. DURING SURGERY, THE ISTENT WAS LOST. THE SURGEON THOROUGHLY PERFORMED I AND A AND WAS UNABLE TO VISUALIZE THE ISTENT WITH POSTOPERATIVE IMAGING. AT THE ONE MONTH POST-OPERATION EXAM THE PATIENT COMPLAINED OF IRRITATION LIKELY DUE TO IOP LOWERING DROPS. THE PATIENTS VISION WAS REPORTED TO HAVE IMPROVED AND THE IOP HAD RETURNED TO BASELINE. THE SURGEON PROVIDED THE FOLLOWING ADDITIONAL INFORMATION TO GLAUKOS ON 10/31/2016. THE SURGEON REPORTED THAT THEY FELT CONFIDENT THAT THE ISTENT WAS SUCCESSFULLY REMOVED VIA I AND A. THE PATIENT PRESENTED POST-OPERATIVELY WITH HYPHEMA RESULTING IN ELEVATED IOP. AT THE TIME OF IOP RISE THE PATIENT WAS ON MORE GLAUCOMA MEDICATIONS COMPARED TO PRE-OPERATION. DUE TO THE IOP INCREASE, THE SURGEON REPORTED CORNEAL EDEMA, BCVA LOSS GREATER THAN 2 LINES COMPARED TO PREOPERATIVE BCVA (THOUGH BOTH IMPROVED BY THE 1 WEEK POST-OPERATIVE EXAM). THE INFLAMMATION WAS TREATED WITH STEROIDS, MURO, ARTIFICIAL TEARS AND COLD COMPRESSES. THE PATIENT'S IOP IS CURRENTLY UNDER CONTROL AND THEIR VISUAL ACUITY HAS IMPROVED. THE PATIENT CONTINUES TO COMPLAIN OF IRRITATION. THE ADVERSE EVENT WAS REPORTED TO HAVE RESOLVED WITH SEQUELAE AS THE IOP IMPROVED BUT THE CORNEA STILL HAS DIFFUSE PIGMENT ON ENDOTHELIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    748333 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION GTS100R 106493 00853704002005

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention