BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 10497980 · Received September 5, 2020

    Report

    Report Number
    3007683266-2020-00019
    Event Type
    Injury
    Date Received
    September 5, 2020
    Date of Event
    July 7, 2020
    Report Date
    September 5, 2020
    Manufacturer
    IVANTIS, INC.
    Product Code
    OGO
    UDI-DI
    00867487000134
    PMA / PMN Number
    P170034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE IDENTIFIERS WERE PROVIDED. THE HYRDUS MICROSTENT REMAINS IMPLANTED IN THE PATIENT IN GOOD POSITION AND IS NOT AVAILABLE FOR EVALUATION. IRITIS, IOP ELEVATION, AND SECONDARY SURGICAL INTERVENTION ARE LISTED IN THE DEVICE LABELING AS POTENTIAL ADVERSE EVENTS. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT CATARACT SURGERY IN COMBINATION WITH HYDRUS MICROSTENT IMPLANTATION IN THE LEFT EYE ON (B)(6) 2020; SURGERY WAS UNEVENTFUL. THE SURGEON REPORTS THAT THE PATIENT EXPERIENCED REBOUND IRITIS IN BOTH EYES WHENEVER THE TOPICAL ANTI-INFLAMMATORY MEDICATION WAS DISCONTINUED. THE MICROSTENT IS WELL POSITIONED IN SCHLEMM'S CANAL. THE PATIENT DID NOT HAVE PREEXISTING CHRONIC IRITIS; HOWEVER, HIS MEDICAL HISTORY INCLUDES A HEART TRANSPLANT AND USE OF ANTI-REJECTION MEDICATION (SYSTEMIC IMMUNOSUPPRESSANT THERAPY). THE PATIENT'S PREOPERATIVE IOP WAS 19 MMHG WITH A BEST CORRECTED VISUAL ACUITY (BCVA) OF 20/30+2. AT THE POSTOPERATIVE EXAMINATION ON (B)(6) 2020, THE PATIENT'S IOP INCREASED TO 25 MMHG (ON MAXIMAL IOP-LOWERING MEDICATIONS, TOPICAL AND SYSTEMIC); AT THIS VISIT THE SLIT LAMP EXAMINATION REVEALED TRACE CELLS AND BCVA WAS 20/40. ON (B)(6) 2020, THE PATIENT'S IOP INCREASED TO 30 MMHG (ON MAXIMAL IOP-LOWERING MEDICATIONS, TOPICAL AND SYSTEMIC) WITH LINGERING INFLAMMATION AND 20/25 BCVA. DUE TO THE PATIENT BEING ON MAXIMAL MEDICATIONS, THE SURGEON IMPLANTED A XEN GEL STENT ON (B)(6) 2020. AT THE EXAMINATION ON (B)(6) 2020 THE HYDRUS WAS IN GOOD POSITION AND IOP DECREASED TO 20 MMHG. THE SURGEON REPORTED IOP ELEVATION, IRITIS, AND XEN IMPLANTATION IN THE PATIENT'S RIGHT EYE WHICH ALSO HAS A HYDRUS MICROSTENT IMPLANTED. THIS REPORT IS FOR THE PATIENT'S LEFT EYE. REFER TO MDR #3007683266-2020-00017 FOR THE PATIENT'S RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962422 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS, INC. F00022 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention