BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 20406756 · Received October 9, 2024

    Report

    Report Number
    3016075957-2024-00045
    Event Type
    Injury
    Date Received
    October 9, 2024
    Report Date
    January 2, 2025
    Manufacturer
    IVANTIS INC
    Product Code
    OGO
    UDI-DI
    00867487000134
    PMA / PMN Number
    P170034
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. LITERATURE CITATION: SACHDEVA N. ET AL., EARLY TO LATE EXPLANTATION OF HYDRUS MICROSTENT MIGS DEVICE: A CASE SERIES: AMERICAN JOURNAL OF OPHTHALMOLOGY CASE REPORTS 2024 JUL 20;36:102105, 1-4. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Additional Manufacturer Narrative · 0

    A SAMPLE WAS NOT RECEIVED AT INVESTIGATION SITE FOR EVALUATION FOR THE REPORT OF MALPOSITIONED, PERSISTENT INFLAMMATION, MICROSTENT REMOVAL WAS PERFORMED THEREFORE, THE CONDITION OF THE PRODUCT COULD NOT BE VERIFIED. NO LOT NUMBER WAS IDENTIFIED WITH THIS COMPLAINT THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE CONDUCTED. A SAMPLE WAS NOT RECEIVED AT THE INVESTIGATION SITE AND NO LOT INFORMATION IS AVAILABLE, THEREFORE, THE ROOT CAUSE FOR THE CUSTOMER COMPLAINT ISSUE CANNOT BE DETERMINED. THE MANUFACTURER INTERNAL REFERENCE NUMBER IS: (B)(4).

    Description of Event or Problem · 0

    A HEALTH CARE PROFESSIONAL PUBLISHED ORIGINAL ARTICLE WITH A PURPOSE EARLY TO LATE EXPLANTATION OF HYDRUS MICROSTENT MIGS DEVICE: A CASE SERIES. THE HYDRUS MICROS TENT WAS APPROVED BY THE FDA IN AUGUST 2018 FOR USE WITH CATARACT SURGERY TO REDUCE IOP IN PATIENTS WITH MILD TO MODERATE PRIMARY OPEN ANGLE GLAUCOMA (POAG). PIVOTAL CLINICAL TRIALS DEMONSTRATED ITS OVERALL SAFETY AND EFFICACY IN LOWERING IOP. HOWEVER, MISPOSITIONING OF THE IMPLANT CAN RESULT IN UVEITIS GLAUCOMA- HYPHEMIA (UGH) SYNDROME NECESSITATING DEVICE EXPLANTATION. HERE WE REPORT FOUR SUCH CASES AND THEIR ASSOCIATED CHALLENGES. WE ALSO HIGHLIGHT THE IMPORTANCE OF EARLY RECOGNITION OF POST-OPERATIVE COMPLICATIONS FOR EASE OF IMPLANT REMOVAL. A 76-YEAR-OLD MAN WITH POAG PRESENTED WITH CHRONIC GRANULOMATOUS IRITIS AFTER UNCOMPLICATED CATARACT AND HYDRUS IMPLANT SURGERY. THE PROXIMAL END OF THE HYDRUS WAS MALPOSITIONED, BEING NOTED TO PROTRUDE FURTHER INTO THE ANTERIOR CHAMBER THAN DESIRED RATHER THAN LYING CLOSE TO THE TM. STILL, IT WAS JUDGED TO BE IN ACCEPTABLE POSITION GIVEN THAT THERE WAS NO CONTACT WITH THE IRIS AND MORE THAN 2/3 OF THE TRANSITION ZONE WAS COVERED. AT THE POM 1, VISUAL ACUITY WAS 20/25 + 1 WITH AN IOP OF 12 MMHG, 1+ ANTERIOR CHAMBER MIXED CELL. THE PATIENT HAD PERSISTENT INFLAMMATION AT SUBSEQUENT VISITS WITH 2+ ANTERIOR CHAMBER GRANULOMATOUS CELLS DESPITE INCREASING STEROIDS, AND HIS IOP WAS 22 MMHG AT A 3-MONTH FOLLOW-UP. THERE WAS NO KNOWN HISTORY OF METAL ALLERGY. ON GONIOSCOPY, THE PROXIMAL END OF THE HYDRUS, WHICH WAS EXTENDING FURTHER INTO THE AC THAN USUAL, WAS NOTED TO BE SEATED SLIGHTLY ABOVE THE IRIS WITH NO CONTACT, SYNECHIAE OR OCCLUSION (FIG. 3). HOWEVER, IT IS SUSPECTED THAT GIVEN THE PROXIMITY, THE IRIS COULD STILL BE IN CONTACT WITH THE IMPLANT DURING BLINKING, LID SQUEEZING, OR PRONE POSITION. HYDRUS REMOVAL WAS PERFORMED AT 3 MONTHS AFTER THE FIRST SURGERY. INTRAOPERATIVELY, MST FORCEPS WERE USED TO REMOVE THE HYDRUS. AN INTENTIONAL 2-CLOCK-HOUR NASAL GONIOTOMY WAS CREATED USING THE HYDRUS MICROSTENT UPON REMOVAL. POST-OPERATIVELY, THE PATIENT WAS ON SLOW PREDNISOLONE TAPER, AND IOP INCREASED UP TO 21 MMHG. POM6, HIS VISUAL ACUITY WAS 20/25 WITH AN IOP OF 9.5 MMHG ON LATANOPROSTENE BUNOD AND BRINZOLAMIDE WITHOUT AC INFLAMMATION. HOWEVER, AT POM 8, THE PATIENT WAS NOTED TO HAVE VISUAL FIELD PROGRESSION AND WAS SCHEDULED FOR TRABECULECTOMY. THIS CASE HIGHLIGHTS CHRONIC GRANULOMATOUS IRITIS DESPITE NO OVERT IMPLANT-IRIS TOUCH SHOULD PROMPT ONE TO SUSPECT AN ADVERSE EVENT RELATED TO THE IMPLANT. EARLY RECOGNITION ALLOWS FOR EASY EXPLANT AND RESOLUTION OF INFLAMMATION. CONCLUSION: HYDRUS MICROS TENTS THAT ARE MISPOSITIONED CAN RESULT IN PERSISTENT UVEITIS-GLAUCOMAHYPHEMA SYNDROME. EXPLANTATION BETWEEN 2 WEEKS AND 11 MONTHS SUCCESSFULLY RESOLVED POST-OPERATIVE UVEITIS AND HYPHEMIA, BUT ALL CASES REQUIRED ADDITIONAL GLAUCOMA-HYPHEMIA SYNDROME. EARLY RECOGNITION IS IMPORTANT SINCE LATE REMOVAL WAS MORE CHALLENGING DUE TO THE IMPLANT BECOMING EMBEDDED IN THE IRIS. SACHDEVA N. ET AL., EARLY TO LATE EXPLANTATION OF HYDRUS MICROSTENT MIGS DEVICE: A CASE SERIES: AMERICAN JOURNAL OF OPHTHALMOLOGY CASE REPORTS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686918 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS INC NA ASKU 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention