BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 20408767 · Received October 9, 2024

    Report

    Report Number
    3016075957-2024-00046
    Event Type
    Injury
    Date Received
    October 9, 2024
    Report Date
    December 31, 2024
    Manufacturer
    IVANTIS INC
    Product Code
    OGO
    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

    ADDITIONAL INFORMATION WAS ADDED IN H.3., H.6 AND H.11. A SAMPLE WAS NOT RECEIVED AT INVESTIGATION SITE FOR EVALUATION FOR THE REPORT OF CHRONIC GRANULOMATOUS UVEITIS, ELEVATED IOP, STENT DEEPLY EMBEDDED IN THE IRIS, REMOVE THE STENT, AND MACULAR EDEMA; 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).

    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: N. SACHDEVA 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).

    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. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685249 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS INC NA ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention