BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 12030003 · Received June 19, 2021

    Report

    Report Number
    3016075957-2021-00026
    Event Type
    Injury
    Date Received
    June 19, 2021
    Report Date
    June 18, 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
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED HYDRUS MICROSTENT IS NOT AVAILABLE FOR EVALUATION. THE DEVICE LOT NUMBER IS UNKNOWN; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS WAS UNABLE TO BE PERFORMED. ADDITIONAL INFORMATION IS BEING REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF NEW INFORMATION IS RECEIVED. INABILITY TO IMPLANT THE MICROSTENT, CYCLODIALYSIS CLEFT, AND HYPOTONY ARE LISTED IN THE DEVICE LABELING AS POTENTIAL ADVERSE EVENTS. THIS REPORT IS BEING FILED FOR THE HYDRUS MICROSTENT THAT WAS NOT IMPLANTED IN THE PATIENT'S RIGHT EYE. REFER TO MDR #3016075957-2021-00025 FOR THE REPORT INVOLVING THE PATIENT'S LEFT EYE. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED INFORMATION ON A PATIENT THAT WAS REFERRED TO HIM. THE IDENTITY OF THE IMPLANTING PHYSICIAN WAS NOT DISCLOSED TO IVANTIS, THEREFORE FOLLOW-UP IS LIMITED. THE (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE HYDRUS MICROSTENT IMPLANTATION IN THE RIGHT EYE (SURGERY DATE UNKNOWN). THE PATIENT HAD PRIOR SURGERY AROUND THIS EYE THAT MAY HAVE IMPACTED THE ABILITY TO IMPLANT THE MICROSTENT. THE IMPLANTATION WAS CHALLENGING AND THE SURGEON FELT A "HARD STOP" IN BOTH DIRECTIONS, RESULTING IN A CYCLODIALYSIS CLEFT. AT THE MOST RECENT POSTOPERATIVE UPDATE PROVIDED TO IVANTIS ON MAY 20, 2021, THE PATIENT WAS STABLE, BUT THE CLEFT IS CAUSING PHYSIOLOGIC HYPOTONY WITH AN INTRAOCULAR PRESSURE (IOP) RANGE OF 4-7 MMHG. THE PATIENT'S BEST CORRECTED VISUAL ACUITY (BCVA) IS IN THE RANGE OF 20/20 TO 20/40 (BASELINE NOT AVAILABLE FOR COMPARISON). AT THE PRESENT TIME, THE PATIENT HAS ELECTED TO MONITOR THE CLEFT AND IS NOT CONSIDERING SURGICAL CLEFT CLOSURE. THE PATIENT HAD HYDRUS IMPLANTATION AND COMPLICATIONS IN THE FELLOW (LEFT) EYE THAT ARE DESCRIBED IN A SEPARATE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926650 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS, INC. F00022 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention