BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IVANTIS, INC.

    MDR report key: 12741551 · Received November 2, 2021

    Report

    Report Number
    3016075957-2021-00045
    Event Type
    Injury
    Date Received
    November 2, 2021
    Date of Event
    August 19, 2021
    Report Date
    November 2, 2021
    Product Code
    OGO
    UDI-DI
    00867487000134
    PMA / PMN Number
    P170034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THEREFORE NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. IT IS UNCLEAR IF THE ANTERIOR SEGMENT INFLAMMATION IS RELATED TO THE HYDRUS MICROSTENT OR LACK OF POST-OPERATIVE ANTI-INFLAMMATORY TOPICAL MEDICATIONS FROM THE "DROPLESS" CATARACT SURGERY PROCEDURE. HYPHEMA AND ANTERIOR SEGMENT INFLAMMATION ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS. (B)(4).

    Description of Event or Problem · 0

    A PATIENT UNDERWENT HYDRUS MICROSTENT IMPLANTATION IN THE LEFT EYE CONCURRENT WITH "DROPLESS" CATARACT SURGERY (WITH INTRAOPERATIVE PHENYLEPHRINE/KETOROLAC AND TRIAMCINOLONE/MOXIFLOXACIN) ON (B)(6) 2021. NO COMPLICATIONS OR ADVERSE EVENTS WERE REPORTED. AT 5 DAYS POST-OP, THE PATIENT COMPLAINED OF CLOUDY VISION AND HAD 4+ CELLS, TRACE FLARE, AND A MICROHYPHEMA INFERIORLY WHICH THE SURGEON ATTRIBUTED TO THE USE OF SYSTEMIC BLOOD THINNERS. TREATMENT WITH DUREZOL FOUR TIMES DAILY WAS INITIATED. AT 1-WEEK POST-OP, 3+ CELL WITH TRACE FLARE. BY 2-WEEK FOLLOW-UP, THE ANTERIOR CHAMBER FINDINGS RESOLVED WITH NO CELLS/FLARE/HYPHEMA. THE DUREZOL WAS TAPERED OFF AND BY 1 MONTH FOLLOW-UP, THE PATIENT HAD NO POST-OPERATIVE IRITIS, UNMEDICATED IOPS REMAINED LOW, AND THE SURGEON REPORTED THE PATIENT WAS HEALING WELL WITH EXPECTED FULL RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1638687 IVANTIS, INC. HYDRUS MICROSTENT OGO F00022 21900026 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention