BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRUS MICROSTENT

    MDR report key: 20415701 · Received October 10, 2024

    Report

    Report Number
    3016075957-2024-00047
    Event Type
    Injury
    Date Received
    October 10, 2024
    Report Date
    January 2, 2025
    Manufacturer
    IVANTIS INC
    Product Code
    OGO
    UDI-DI
    00867487000134
    PMA / PMN Number
    P170034
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN H.3., H.6. AND H.11. A SAMPLE WAS NOT RECEIVED AT INVESTIGATION SITE FOR EVALUATION FOR THE REPORT OF PERSISTENT HYPHEMA, UNCONTROLLED INTRAOCULAR PRESSURE, MICROSTENT EXPLANTATION, IMPLANT WAS SURROUNDED BY PERIPHERAL ANTERIOR SYNECHIAE AND IRIS TISSUES; 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 (B)(6) 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 71-YEAR-OLD MAN WITH POAG ON DUAL ANTI-PLATELET THERAPY (ASPIRIN AND CLOPIDOGREL) PRESENTED WITH PERSISTENT HYPHEMA AND UNCONTROLLED IOP AFTER THE HYDRUS IMPLANT. DURING HIS CATARACT AND HYDRUS IMPLANT SURGERY, SIGNIFICANT BLEEDING WAS NOTED FROM THE INITIAL GONIOTOMY SITE FOR HYDRUS INSERTION, AND ADDITIONAL VISCOELASTIC WAS ABLE TO TAMPONADE THE BLEED INTRAOPERATIVELY. IN THE POST-OPERATIVE PERIOD, THE PATIENT DEVELOPED A LARGE HYPHEMA AND NASAL CLOT WITH AN IOP OF 64 MMHG AND WAS STARTED ON ORAL ACETAZOLAMIDE. CLOPIDOGREL WAS STOPPED AFTER CONSULTING THE CARDIOLOGIST, BUT ASPIRIN 81 MG WAS CONTINUED. THE PATIENT CONTINUED TO HAVE HYPHEMA WITH UNCONTROLLED IOP ON MAXIMAL MEDICAL THERAPY. B-SCAN WAS NEGATIVE FOR POSTERIOR SEGMENT HEMORRHAGE. THE PATIENT UNDERWENT ANTERIOR CHAMBER WASHOUT WITH HYDRUS EXPLANTATION AND AHMED GLAUCOMA VALVE IMPLANTATION 16 DAYS AFTER THE FIRST SURGERY. INTRAOPERATIVELY, THE PROXIMAL END OF THE IMPLANT WAS SURROUNDED BY PERIPHERAL ANTERIOR SYNECHIAE AND IRIS TISSUES. IT WAS PULLED FREE USING A SINSKY HOOK, AND A HYDRUS DEPLOYER WAS USED TO RETRACT THE IMPLANT INTO THE ANTERIOR CHAMBER AND OUT OF THE EYE. ON POD 1, IOP WAS 11 MMHG WITH VISUAL ACUITY OF HAND MOTION AND NO HYPHEMA, BUT VITREOUS HEMORRHAGE WAS NOTED. THE PATIENT WAS STARTED ON PREDNISOLONE ACETATE FOUR TIMES DAILY WITH A GRADUAL TAPER. BY 5 MONTHS, THE VITREOUS HEMORRHAGE HAD CLEARED WITH IMPROVEMENT IN VISUAL ACUITY TO 20/40, AND IOP WAS 15 MMHG ON MEDICATION. THIS CASE HIGHLIGHTS THAT PATIENTS WITH HYDRUS IMPLANTS TREATED WITH ANTI-PLATELET THERAPY MAY BE AT HIGHER RISK FOR PERSISTENT HYPHEMA IN CASES OF IMPLANT MALPOSITION. 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
    1946222 HYDRUS MICROSTENT INTRAOCULAR PRESSURE LOWERING IMPLANT OGO IVANTIS INC NA ASKU 00867487000134

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention