BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS® MICROSTENT

    MDR report key: 13023668 · Received December 17, 2021

    Report

    Report Number
    3016075957-2021-00054
    Event Type
    Injury
    Date Received
    December 17, 2021
    Date of Event
    November 18, 2021
    Report Date
    December 16, 2021
    Manufacturer
    IVANTIS INC.
    Product Code
    OGO
    PMA / PMN Number
    P170034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE HYDRUS MICROSTENT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR EVALUATION. DEVICE IDENTIFIERS HAVE BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF NEW INFORMATION IS RECEIVED. ELEVATED INTRAOCULAR PRESSURE, INFLAMMATION, AND SECONDARY SURGICAL INTERVENTION ARE LISTED IN THE DEVICE LABELING AS POTENTIAL ADVERSE EVENTS. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 0

    A PATIENT WITH MODERATE PRIMARY OPEN ANGLE GLAUCOMA ON MAXIMAL IOP-LOWERING MEDICATION UNDERWENT COMBINED CATARACT SURGERY WITH HYDRUS IMPLANTATION ON (B)(6) 2021. THE INITIAL NASAL IMPLANTATION WAS SUBOPTIMAL SO THE MICROSTENT WAS PLACED MORE INFERIORLY. AT ONE-DAY POST-OP, INTRAOCULAR PRESSURE (IOP) WAS 12 MMHG BUT ELEVATED TO THE 30S AT 2-WEEK POST-OP. THE SURGEON STATED THAT THE TIMING SUGGESTED STEROID RESPONSE" SO THE PREDNISOLONE 1% EYEDROP WAS SWITCHED TO LOTEMAX AND MAXIMAL IOP-LOWERING THERAPY (INCLUDING DIAMOX) WAS RE-INITIATED. ON SUBSEQUENT VISITS, IOP RANGED IN THE HIGH 20S TO HIGH 30S WITH CONTINUED INFLAMMATION DUE TO THE LESS EFFECTIVE LOTEMAX STEROID. THE SURGEON NOTED THE HYDRUS WAS IN GOOD POSITION AND WAS NOT OBSTRUCTED; THE PATIENT HAD NO PREVIOUS HISTORY OF INFLAMMATION. SURGERY TO PLACE AN AQUEOUS SHUNT WAS PERFORMED AT THE END OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1932392 HYDRUS® MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS INC. F00018

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention