BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 11668788 · Received April 14, 2021

    Report

    Report Number
    3016075957-2021-00010
    Event Type
    Injury
    Date Received
    April 14, 2021
    Date of Event
    March 12, 2021
    Report Date
    April 14, 2021
    Manufacturer
    IVANTIS, INC.
    Product Code
    OGO
    UDI-DI
    00867487000134
    PMA / PMN Number
    P170034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HYDRUS MICROSTENT WAS DISCARDED BY THE USER FACILITY AND IS NOT AVAILABLE FOR EVALUATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. IN THIS CASE THE EVENT OCCURRED DUE TO UNANTICIPATED PATIENT MOVEMENT DURING ATTEMPTED MICROSTENT IMPLANTATION. CYCLODIALYSIS, HYPOTONY, AND INABILITY TO IMPLANT THE MICROSTENT ARE LISTED IN THE DEVICE LABELING AS POTENTIAL ADVERSE EVENTS. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    AS PART OF A POST-APPROVAL STUDY, A (B)(6) YEAR-OLD MALE SUBJECT UNDERWENT CATARACT SURGERY ON (B)(6) 2021, WITH ATTEMPTED IMPLANTATION OF THE HYDRUS MICROSTENT IN THE RIGHT EYE. DURING THE CATARACT PORTION OF THE PROCEDURE PRIOR TO HYDRUS SURGERY, THE SUBJECT MOVED UNEXPECTEDLY DURING CREATION OF THE CAPSULORHEXIS RESULTING IN AN ANTERIOR CAPSULE TEAR. FOLLOWING INTRAOCULAR LENS PLACEMENT, AN INITIAL ATTEMPT AT HYDRUS IMPLANTATION WAS MADE. THE MICROSTENT WAS NOT PROPERLY POSITIONED SO THE SURGEON ATTEMPTED HYDRUS IMPLANTATION A SECOND TIME. DURING THE SECOND IMPLANTATION ATTEMPT WHILE INSERTING THE HYDRUS INTO THE TRABECULAR MESHWORK, THE SUBJECT MOVED AGAIN, RESULTING IN A SMALL CYCLODIALYSIS CLEFT. NO FURTHER ATTEMPTS AT HYDRUS IMPLANTATION WERE MADE. PREOPERATIVELY, THE SUBJECT'S IOP WAS 13 MMHG (ON 1 IOP-LOWERING MEDICATION) AND HIS BEST CORRECTED VISUAL ACUITY (BCVA WAS 20/30). FIVE HOURS AFTER SURGERY, THE SUBJECT'S INTRAOCULAR PRESSURE (IOP) WAS 17 MMHG (ON THE SAME IOP-LOWERING MEDICATION). ON (B)(6) 2021, THE SUBJECT PRESENTED WITH A DEEP ANTERIOR CHAMBER (AC) AND HYPOTONY (5 MMHG ON THE SAME IOP-LOWERING MEDICATION). ON (B)(6) 2021, THE SUBJECT'S IOP DECREASED TO 2.5 MMHG (ON THE SAME IOP-LOWERING MEDICATION) WITH DEEP AC; GONIOSCOPIC EXAMINATION CONFIRMED A SMALL CYCLODIALYSIS (1 CLOCK HOUR IN SIZE). THERE WAS NO LOSS OF BCVA REPORTED POSTOPERATIVELY. THE SUBJECT IS SCHEDULED TO BE SEEN NEXT AT 1 MONTH POSTOPERATIVELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560843 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS, INC. F00022 20900187 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other