BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 12026676 · Received June 18, 2021

    Report

    Report Number
    3016075957-2021-00025
    Event Type
    Injury
    Date Received
    June 18, 2021
    Date of Event
    May 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. DEVICE IDENTIFIERS AND ADDITIONAL INFORMATION HAVE BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE FILED IF NEW INFORMATION IS RECEIVED. MICROSTENT MALPOSITION, MICROSTENT-IRIS TOUCH, MICROSTENT EXPLANTATION, HYPHEMA AND DECREASED VISION ARE LISTED IN THE DEVICE LABELING AS POTENTIAL ADVERSE EVENTS. THIS REPORT IS BEING FILED FOR THE HYDRUS MICROSTENT THAT WAS IMPLANTED IN THE PATIENT'S LEFT EYE. REFER TO MDR #3016075957-2021-00026 FOR THE REPORT INVOLVING THE PATIENT'S RIGHT EYE. MANUFACTURER REFERENCE #: (B)(4).

    Description of Event or Problem · 1

    A SURGEON REPORTED INFORMATION ON A REFERRED PATIENT IN WHOM THE HYDRUS MICROSTENT WAS NOT PROPERLY POSITIONED. THE IDENTITY OF THE IMPLANTING PHYSICIAN WAS NOT DISCLOSED TO IVANTIS, THEREFORE FOLLOW-UP IS LIMITED. THE (B)(6)-YEAR-OLD FEMALE PATIENT UNDERWENT UNEVENTFUL CATARACT SURGERY WITH HYDRUS MICROSTENT IMPLANTATION IN THE LEFT EYE ON (B)(6) 2020. THE IMPLANTING SURGEON INDICATED TO THE CONSULTING PHYSICIAN THAT THERE WERE NO ISSUES WITH MICROSTENT IMPLANTATION IN THE LEFT EYE. THE PATIENT HAD PRIOR SURGERY FOR THE FELLOW EYE. ON (B)(6) 2021, THE PATIENT'S INTRAOCULAR PRESSURE (IOP) WAS 14 MMHG ON NO IOP-LOWERING MEDICATIONS AND HER BEST-CORRECTED VISUAL ACUITY (BCVA) WAS 20/20; ON (B)(6) 2021, IOP WAS 15-17 MMHG (UNMEDICATED) AND BCVA WAS UNCHANGED. THE PATIENT WAS SUBSEQUENTLY REFERRED TO A CONSULTING PHYSICIAN, WHO INDICATED THAT STENT POSITIONING MAY BE CAUSING A LACK OF (EXPECTED) IOP REDUCTION. BASELINE AND TARGET IOP LEVELS WERE NOT PROVIDED TO IVANTIS, SO DEVICE EFFECTIVENESS COULD NOT BE ASSESSED. UNMEDICATED IOP LEVELS FOR THIS PATIENT WERE 14-17 MMHG THROUGH 6-MONTHS POSTOPERATIVELY; THESE IOP LEVELS ARE ANTICIPATED FOR A CANAL BASED MIGS DEVICE AND WERE OBSERVED IN THE HORIZON PIVOTAL CLINICAL STUDY. GONIOSCOPIC EXAMINATION ON (B)(6) 2021 NOTED MICROSTENT "DISLODGED, ONLY 1 WINDOW IN THE CANAL; DISTAL TIP EXTRUSION". FURTHER EXPLANATION REVEALED DISTAL TWO WINDOWS EXTRUDING INTO THE ANTERIOR CHAMBER (AC) AND IRIS TOUCH. HOWEVER, NO MEDICAL INTERVENTION WAS REQUIRED (I.E., STEROIDS). ON (B)(6) 2021, THE HYDRUS MICROSTENT WAS EXPLANTED AND A 270-DEGREE VISCODILATION PROCEDURE WAS PERFORMED; NO COMPLICATIONS OR ADVERSE EVENTS WERE REPORTED. THE FOLLOWING DAY, THE PATIENT'S IOP WAS 9 MMHG AND BCVA WAS 20/80 AND THE SLIT-LAMP EXAMINATION SHOWED HYPHEMA AND NORMAL POSTOPERATIVE APPEARANCE. POSTOPERATIVE MEDICATIONS INCLUDED PREDNISOLONE FORTE AND OFLOXACIN. FOLLOWING MICROSTENT EXPLANTATION AND VISCODILATION, THE PATIENT'S IOP IS GOOD AND THE SURGEON ANTICIPATES A COMPLETE VISUAL RECOVERY. THE PATIENT HAD ATTEMPTED SURGERY AND COMPLICATIONS IN THE FELLOW (RIGHT) EYE THAT ARE DESCRIBED IN A SEPARATE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922758 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS, INC. F00022 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention