BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 11606413 · Received April 1, 2021

    Report

    Report Number
    3016075957-2021-00008
    Event Type
    Injury
    Date Received
    April 1, 2021
    Date of Event
    March 4, 2021
    Report Date
    April 1, 2021
    Manufacturer
    IVANTIS, INC.
    Product Code
    OGO
    UDI-DI
    00867487000134
    PMA / PMN Number
    P170034
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. ALTHOUGH THE DEVICE IS NOT AVAILABLE FOR EVALUATION, MEDICAL INVESTIGATION OF THE EVENT LED TO A CONCLUSION OF USE ERROR. A CAUTION TO AVOID INADVERTENT CAPTURE OF TISSUE WHEN RECAPTURING THE MICROSTENT IS INCLUDED IN THE DEVICE LABELING. IRIDODIALYSIS, HYPHEMA, PUPIL IRREGULARITY, 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

    A PATIENT UNDERWENT CATARACT SURGERY ON (B)(6), 2021, WITH ATTEMPTED IMPLANTATION OF THE HYDRUS MICROSTENT. THERE WERE NO COMPLICATIONS DURING THE CATARACT PORTION OF THE PROCEDURE; HOWEVER, DURING MICROSTENT IMPLANTATION HEME OBSCURED VISUALIZATION. FOLLOWING IRRIGATION AND ASPIRATION (I/A), THE SURGEON NOTED THE HYDRUS WAS DEPLOYED POSTERIORLY. THE MICROSTENT WAS RECAPTURED USING THE DELIVERY SYSTEM, HOWEVER IRIS TISSUE WAS INADVERTENTLY CAPTURED BETWEEN THE IMPLANT AND THE DELIVERY SYSTEM AND THE SURGEON WAS UNABLE TO RETRACT THE MICROSTENT. AFTER REMOVAL OF THE DEVICE FROM THE EYE ADDITIONAL I/A WAS PERFORMED AND AN IRIDODIALYSIS (APPROXIMATELY 2 CLOCK HOURS IN SIZE) WAS REPORTED. NO ADDITIONAL ATTEMPTS TO IMPLANT THE MICROSTENT WERE MADE. THE COMPANY REPRESENTATIVE IN ATTENDANCE FOR THE CASE REPORTED OBSERVING INTRAOPERATIVE WOUND LEAKAGE WHICH WAS ATTRIBUTED TO INADVERTENT PLACEMENT OF EXCESS PRESSURE ON THE INCISION SITE FROM THE DELIVERY SYSTEM CANNULA. THERE WAS NO VITREOUS LOSS, NO NEED FOR SUTURES, AND NO POSTOPERATIVE WOUND LEAK OR INFECTION. ON POSTOPERATIVE DAY 1, VISUAL ACUITY WAS 20/400, IOP WAS 8 MMHG AND A 1/2 MM LAYERED HYPHEMA WAS REPORTED. THE SURGEON WAS ABLE TO VISUALIZE THE IRIDODIALYSIS (LOCATED FROM 2-4 O'CLOCK) AND ADVISED THE PATIENT TO KEEP HIS HEAD ELEVATED WITH LIMITED ACTIVITY. ON DAY 10, VISUAL ACUITY IMPROVED TO 20/40, IOP WAS 14 MMHG, AND TRACE LAYERED HYPHEMA AND A SLIGHT PUPIL IRREGULARITY WERE REPORTED. THE PATIENT IS SCHEDULED FOR A FOLLOW UP EXAMINATION IN APPROXIMATELY 3 WEEKS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502615 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS, INC. F00022 20900195 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention| S