BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 9891586 · Received March 27, 2020

    Report

    Report Number
    3011299751-2020-00148
    Event Type
    Injury
    Date Received
    March 27, 2020
    Report Date
    March 27, 2020
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: ONG, JEB ALDEN ET. AL, "OUTCOMES OF AB INTERNO GELATIN MICROSTENT WITH MMC USING TARGETED SUPRA-TENON'S PLACEMENT." ALLERGAN IS UNABLE TO REQUEST FURTHER DETAILS FROM AUTHORS AS NO CONTACT INFORMATION WAS PROVIDED. THE EVENTS OF DELLEN, DEVICE MIGRATION, EXPOSURE, GEL STENT CURLING, GEL STENT BLOCKAGE, AND MALIGNANT GLAUCOMA ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. (B)(6).

    Description of Event or Problem · 1

    A COMPANY REPRESENTATIVE SAW A POSTER CONTAINING DETAILS OF THE ARTICLE "OUTCOMES OF AB INTERNO GELATIN MICROSTENT WITH MMC USING TARGETED SUPRA-TENON'S PLACEMENT" WHICH NOTED SERIOUS ADVERSE EVENTS OF 8 INSTANCES OF BLOCKED XEN ; 5 INSTANCES OF EXPOSED XEN ; 4 INSTANCES OF BENT XEN ; 2 INSTANCES OF MIGRATED XEN ; 3 INSTANCES OF MALIGNANT GLAUCOMA ; 2 INSTANCES OF A DELLEN IN 147 EYES. INTERVENTIONS AND REOPERATIONS FOR TREATMENT FOR ADVERSE EVENTS WERE NOTED AS AC REFORMATION IN 10 EYES, 7 EYES NEEDING ANTERIOR CHAMBER TAP, 2 EYES REQUIRING IRIS SWEEP, 1 EYE REQUIRING LASER TRABECULOPLASTY, 6 EYES REQUIRING A GLAUCOMA VALVE, 3 EYES REQUIRING XEN EXPLANT, 2 EYES REQUIRING TRABECULECTOMY, 2 EYES REQUIRING A MICROSHUNT, 2 EYES REQUIRING A BLEB REVISION, AND ONE EYE REQUIRING A XEN AMPUTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354639 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention