BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 11607195 · Received April 2, 2021

    Report

    Report Number
    3016075957-2021-00009
    Event Type
    Malfunction
    Date Received
    April 2, 2021
    Date of Event
    March 4, 2021
    Report Date
    April 2, 2021
    Manufacturer
    IVANTIS, INC.
    Product Code
    OGO
    UDI-DI
    00867487000134
    PMA / PMN Number
    P170034
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HYDRUS MICROSTENT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR EVALUATION. DEVICE IDENTIFIERS HAVE BEEN REQUESTED. MICROSTENT-IRIS TOUCH, DEVICE MIGRATION, AND PUPIL IRREGULARITY ARE LISTED IN THE DEVICE LABELING AS POTENTIAL ADVERSE EVENTS. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    THE HYDRUS MICROSTENT WAS IMPLANTED IN A PATIENT IN 2020 (MONTH AND DAY UNKNOWN). AT 9 MONTHS POSTOPERATIVELY, THE SURGEON REPORTED THE PATIENT HAD AN ABNORMAL IRIS WITH SLIGHT PUPIL PEAKING AND SLIGHT DEVICE-IRIS TOUCH AT THE STENT INLET. THE SURGEON INDICATED THAT THE DEVICE HAD MIGRATED INTO THE ANTERIOR CHAMBER (AC), BUT COULD NOT CONFIRM WHEN IT OCCURRED. THE AC IS QUIET, VISUAL ACUITY WAS 20/15 AND IOP DECREASED FROM 22 MMHG TO 15 MMHG. THE PATIENT HAS NOT EXPERIENCED INFLAMMATION, OCULAR DISCOMFORT, OR OTHER CLINICAL SEQUELAE. THE SURGEON WILL CONTINUE TO MONITOR THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507883 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS, INC. F00022 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1