BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 11873933 · Received May 25, 2021

    Report

    Report Number
    3016075957-2021-00017
    Event Type
    Injury
    Date Received
    May 25, 2021
    Date of Event
    April 19, 2021
    Report Date
    May 24, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE HYDRUS MICROSTENT REMAINS IMPLANTED IN THE PATIENT AND IS NOT AVAILABLE FOR EVALUATION. DEVICE IDENTIFIERS AND ADDITIONAL PATIENT INFORMATION HAVE BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF NEW INFORMATION IS RECEIVED. ELEVATED IOP, MICROSTENT-IRIS TOUCH, MICROSTENT OBSTRUCTION, AND UNPLANNED SECONDARY OCULAR SURGICAL REINTERVENTION ARE LISTED IN THE DEVICE LABELING AS POTENTIAL ADVERSE EVENTS. MANUFACTURER REFERENCE #: CMP (B)(4).

    Description of Event or Problem · 1

    THE HYDRUS MICROSTENT WAS IMPLANTED IN A FEMALE PATIENT ON (B)(6) 2019. PREOPERATIVELY, THE PATIENT'S PEAK INTRAOCULAR PRESSURE (IOP) WAS 25 MMHG (MEDICATIONS UNKNOWN). POSTOPERATIVELY, IOP REMAINED CONTROLLED WITH TOPICAL IOP-LOWERING MEDICATIONS. UPON EXAMINATION AT AN UNKNOWN DATE, THE HYDRUS WAS LYING FLAT ON THE TRABECULAR MESHWORK (TM) WITHOUT MUCH SEPARATION FROM THE INLET AND THE TM, HOWEVER, THE PORTION OF THE MICROSTENT IN THE TM WAS IN GOOD POSITION. AT APPROXIMATELY 14 MONTHS POSTOPERATIVELY ((B)(6) 2021), THE PATIENT'S IOP WAS 28 MMHG ON 3-IOP LOWERING MEDICATIONS AND IRIS TISSUE COVERED THE INLET OF THE MICROSTENT. ON (B)(6) 2021, IOP INCREASED TO 34 MMHG AND THE SURGEON PERFORMED YAG LASER TO REMOVE THE IRIS TISSUE FROM THE MICROSTENT; IMMEDIATELY FOLLOWING THE PROCEDURE IOP DECREASED TO 30 MMHG. ON (B)(6) 2021, IOP INCREASED TO 39 MMHG AND THE SURGEON REPORTED THE IRIS TISSUE WAS NO LONGER OBSTRUCTING THE INLET, HOWEVER, HE OBSERVED A MEMBRANE OVER THE MICROSTENT INLET AND AT THE TRANSITION ZONE. SYSTEMIC IOP-LOWERING MEDICATION WAS PRESCRIBED TWICE PER DAY. THE PATIENT WAS SCHEDULED TO BE SEEN THE FOLLOWING WEEK. THIS CASE WAS DISCUSSED WITH THE IVANTIS SURGICAL CONSULTANT (GLAUCOMA SPECIALIST). THE FOLLOWING IS A SUMMARY OF THE CASE BASED ON THE INFORMATION PROVIDED TO THE CONSULTANT. THE PATIENT DID WELL FOR OVER A YEAR UNTIL A BROAD AREA OF GONIOSYNECHIAE OBSTRUCTED THE FULL EXTENT OF THE HYDRUS, INCLUDING THE INLET. THE SURGEON USED A ND:YAG LASER TO REMOVE THE SYNECHIAE FROM THE BODY OF THE STENT, BUT DID NOT TREAT THE INLET AREA. THE SURGEON NOTED THE ANGLE DEEPENED AND THE BODY OF THE HYDRUS WAS SEEN FOLLOWING LASER TREATMENT. THE PATIENT'S IOP DECREASED MODESTLY, BUT INCREASED WITHIN A WEEK. THE PATIENT DOES NOT WISH TO HAVE ADDITIONAL INCISIONAL SURGERY DUE TO POOR OUTCOMES FOLLOWING MULTIPLE SURGICAL INTERVENTIONS IN THE FELLOW EYE, SO A COURSE OF TREATMENT USING NON-INVASIVE LASER SURGERIES AND MEDICATIONS WAS DISCUSSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774770 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS, INC. F00022 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention