BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 11984043 · Received June 11, 2021

    Report

    Report Number
    3016075957-2021-00021
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    May 13, 2021
    Report Date
    June 11, 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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HYDRUS MICROSTENT AND DELIVERY SYSTEM WERE RETURNED TO IVANTIS FOR EVALUATION. THE MICROSTENT MET DIMENSIONAL AND VISUAL SPECIFICATIONS. FUNCTIONAL TESTING USING THE MICROSTENT AND DELIVERY SYSTEM WAS PERFORMED; THE DELIVERY SYSTEM FUNCTIONED AS INTENDED DURING ADVANCEMENT, RELEASE, RETRACTION AND RECAPTURE. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THIS MANUFACTURING LOT AND THERE WERE NO DISCREPANCIES OR UNUSUAL FINDINGS. BASED ON THE INFORMATION PROVIDED BY THE SURGEON AND THE RESULTS OF THE PRODUCT EVALUATION, THE EVENT WAS ATTRIBUTED TO USER ERROR. ADDITIONAL PATIENT INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF NEW INFORMATION IS RECEIVED. THE DEVICE LABELING INCLUDES THE FOLLOWING INSTRUCTIONS AND CAUTIONS RELATED TO THE INABILITY TO RELEASE THE MICROSTENT: "IF THE INTERLOCK DOES NOT APPEAR TO RELEASE THE MICROSTENT, SLIGHTLY WITHDRAW THE CANNULA TIP FROM THE TM. AFTER THIS CANNULA TIP ADJUSTMENT, THE MICROSTENT SHOULD RELEASE. CAUTION: IF THE MICROSTENT DOES NOT RELEASE FROM THE INTERLOCK, OR IF THE MICROSTENT CANNOT BE RETRACTED INTO THE CANNULA, WITHDRAW THE ENTIRE DELIVERY SYSTEM FROM THE EYE." IRIDODIALYSIS, CYCLODIALYSIS, HYPHEMA, 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 (B)(6) YEAR-OLD FEMALE PATIENT UNDERWENT CATARACT SURGERY WITH ATTEMPTED IMPLANTATION OF THE HYDRUS MICROSTENT IN THE RIGHT EYE ON (B)(6) 2021. PREOPERATIVELY, THE PATIENT'S IOP WAS 18 MMHG ON AN UNKNOWN NUMBER OF INTRAOCULAR PRESSURE (IOP) LOWERING MEDICATIONS. THE MICROSTENT WAS SUCCESSFULLY INSERTED INTO SCHLEMM'S CANAL, BUT THE STENT WOULD NOT DISENGAGE FROM THE DELIVERY SYSTEM. DURING THE SURGEON'S ATTEMPT TO DISENGAGE THE MICROSTENT, THE PATIENT MOVED UNEXPECTEDLY. THE MICROSTENT AND FULLY-EXTENDED DELIVERY SYSTEM WERE ABRUPTLY PULLED FROM SCHLEMM'S CANAL AND OUT OF THE EYE RESULTING IN TRAUMATIC INJURY TO SEVERAL ANGLE STRUCTURES (GONIOTOMY, IRIDODIALYSIS, CYCLODIALYSIS) AND HYPHEMA IN THE SAME QUADRANT. ONCE OUTSIDE OF THE EYE, THE HYDRUS DISENGAGED EASILY FROM THE DELIVERY SYSTEM. THE STANDARD POSTOPERATIVE REGIMEN WAS INITIATED (ANTIBIOTIC AND ANTI-INFLAMMATORY EYE DROPS), ATROPINE WAS ADDED, AND IOP-LOWERING MEDICATIONS WERE DISCONTINUED. NO SURGICAL INTERVENTIONS ARE PLANNED AT THIS TIME. AT THE ONE-DAY POSTOPERATIVE VISIT ON (B)(6) 2021, THE PATIENT'S IOP DECREASED TO 8 MMHG. AT THE ONE-WEEK VISIT, IOP WAS 12 MMHG AND VISUAL ACUITY (VA) WAS 20/25; SLIT LAMP EXAMINATION (SLE) SHOWED THE ANTERIOR CHAMBER (AC) WAS DEEP AND THE HYPHEMA WAS RESOLVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879960 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS, INC. F00022 20900487 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Disability