BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS® MICROSTENT

    MDR report key: 12867055 · Received November 24, 2021

    Report

    Report Number
    3016075957-2021-00050
    Event Type
    Injury
    Date Received
    November 24, 2021
    Date of Event
    October 28, 2021
    Report Date
    December 20, 2021
    Manufacturer
    IVANTIS INC.
    Product Code
    OGO
    UDI-DI
    00867487000134
    PMA / PMN Number
    P170034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE EXPLANTED MICROSTENT WAS RECEIVED BY IVANTIS ON 11/08/2021. THE IMPLANT MET SPECIFICATION AND PASSED FUNCTIONAL TESTING WITH A KNOWN GOOD DELIVERY SYSTEM. THE ORIGINAL DELIVERY SYSTEM WAS UNAVAILABLE BECAUSE IT WAS DISCARDED AFTER THE ORIGINAL IMPLANTATION ON (B)(6) 2021. MANUFACTURER REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 0

    THE EXPLANTED MICROSTENT IS BEING RETURNED FOR FURTHER EVALUATION, BUT RECEIPT OF THE DEVICE IS PENDING. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS LOT AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE EVALUATION OF THE DEVICE IS COMPLETED. MICROSTENT MALPOSITION, MICROSTENT EXPLANTATION, AND SECONDARY SURGICAL RE-INTERVENTION ARE LISTED IN THE DEVICE LABELING AS POTENTIAL ADVERSE EVENTS. (B)(4).

    Description of Event or Problem · 0

    A PATIENT WITH PRIMARY OPEN-ANGLE GLAUCOMA UNDERWENT COMBINED CATARACT SURGERY WITH HYDRUS MICROSTENT IMPLANTATION ON (B)(6) 2021. THE SURGEON ENCOUNTERED "POOR VISIBILITY WHEN PUTTING IN THE STENT" AND COULD NOT CONFIRM PROPER PLACEMENT. AT THE 1-DAY POST-OP VISIT, HE VIEWED THE MICROSTENT AND DETERMINED IT WAS NOT POSITIONED PROPERLY. THREE DAYS LATER, THE ORIGINAL MICROSTENT WAS EXPLANTED AND A SECOND MICROSTENT WAS IMPLANTED WITHOUT COMPLICATIONS. THE PATIENT IS "DOING WELL" AT LAST EXAM ((B)(6) 2021) .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1767861 HYDRUS® MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS INC. F00022 21900185 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention