BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 11874162 · Received May 25, 2021

    Report

    Report Number
    3016075957-2021-00018
    Event Type
    Injury
    Date Received
    May 25, 2021
    Report Date
    May 24, 2021
    Manufacturer
    IVANTIS, INC.
    Product Code
    OGO
    UDI-DI
    00867487000134
    PMA / PMN Number
    P170034
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 AND ADDITIONAL PATIENT INFORMATION HAVE BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF NEW INFORMATION IS RECEIVED. ELEVATED IOP, MICROSTENT-IRIS TOUCH, MICROSTENT OBSTRUCTION, AND UNPLANNED SECONDARY OCULAR SURGICAL REINTERVENTION 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 MALE PATIENT ON AN UNKNOWN DATE. ON (B)(6) 2021, THE SURGEON REPORTED THAT THE PATIENT HAD ELEVATED INTRAOCULAR PRESSURE (IOP) WITH IRIS TISSUE ON THE INLET OF THE MICROSTENT FOR WHICH THE SURGEON PERFORMED AN ND:YAG LASER PROCEDURE (ON AN UNKNOWN DATE). ON (B)(6) 2021, THE SURGEON INDICATED THAT THE PATIENT WAS SCHEDULED TO BE SEEN THAT WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776425 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS, INC. F00022 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention