BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISTENT TRABECULAR MICRO-BYPASS

    MDR report key: 8633722 · Received May 22, 2019

    Report

    Report Number
    2032546-2019-00071
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    April 26, 2019
    Report Date
    May 23, 2019
    Manufacturer
    GLAUKOS CORPORATION
    Product Code
    OGO
    PMA / PMN Number
    P080030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ATTACHED ARTICLE REFERENCED IN THE INITIAL REPORT. MFR# REFERENCE: (B)(4) - ATTACHMENT: [RANDOMIZED COMPARISON OF HYDRUS AND ISTENT.PDF].

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: ESTIMATED BASED TRIAL START DATE AND PUBLICATION DATE. THE DEVICES WERE NOT AVAILABLE; THEREFORE, PRODUCT TESTING ON THESE ACTUAL DEVICES COULD NOT BE PERFORMED. THE DEVICE IDENTIFIERS WERE NOT PROVIDED; THEREFORE, THE DEVICE HISTORY RECORDS AND COMPLAINT HISTORY RECORDS FOR THIS DEVICE LOT NUMBER COULD NOT BE REVIEWED. A REVIEW OF THE DEVICE LABELING WAS COMPLETED. DECREASE/IMPAIRED VISION AND ELEVATED IOP ARE IDENTIFIED IN THE LABELING AS KNOWN INHERENT RISKS OF TRABECULAR MICRO-BYPASS STENT PROCEDURE. THE IFU ADEQUATELY PROVIDES INSTRUCTIONS FOR STENT IMPLANTATION, PRECAUTIONS, AND WARNINGS FOR THE PROPER USE AND HANDLING OF THE DEVICE. THE IFU STATES THAT THE SAFETY AND EFFECTIVENESS OF THE ISTENT INJECT TRABECULAR MICRO BYPASS SYSTEM HAS NOT BEEN ESTABLISHED FOR IMPLANTATION OF MORE THAN TWO STENTS IN ONE EYE. MFR# REFERENCE: (B)(4). PLEASE REFERENCE 2032546-2019-00072 FOR STENT OBSTRUCTION REPORTED IN TRABECULAR MICRO BYPASS STENT GROUP.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED THROUGH REVIEW OF AN ARTICLE. IN THE TWO (2) ISTENTS GROUP, THERE WAS ONE (1) CASE OF BCVA LOSS OF TWO (2) LINES, FOUR (4) CASES OF IOP ELEVATION OVER BASELINE AND DEVICE OBSTRUCTIONS (UNSPECIFIED QUANTITY) RELATED TO IRIS OR OTHER TISSUE ADHESION. TWO (2) SUBJECTS REQUIRED SUBSEQUENT GLAUCOMA SURGERY DUE TO UNCONTROLLED IOP DESPITE MAXIMUM MEDICAL THERAPY AT AN UNKNOWN POSTOP PERIOD. THIS IS A PROSPECTIVE STUDY TO COMPARE THE EFFICACY OF DIFFERENT MIGS DEVICES FOR REDUCING INTRAOCULAR PRESSURE (IOP) AND MEDICATIONS IN OPEN-ANGLE GLAUCOMA (OAG). THIS REPORT REFERENCES THE ADVERSE EVENTS OCCURRING IN TRABECULAR MICRO BYPASS STENT GROUP. ADDITIONAL INFORMATION IS BEING REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424926 ISTENT TRABECULAR MICRO-BYPASS INTRAOCULAR PRESSURE LOWERING IMPLANT OGO GLAUKOS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention