BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 8289294 · Received January 30, 2019

    Report

    Report Number
    3011299751-2019-00012
    Event Type
    Injury
    Date Received
    January 30, 2019
    Date of Event
    October 1, 2018
    Report Date
    January 30, 2019
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LAPIRA, MATTHEW, ET AL. "EXTRUSION AND BREAKAGE OF XEN GEL STENT RESULTING IN ENDOPHTHALMITIS." JOURNAL OF GLAUCOMA, VOL. 27, NO. 10, OCTOBER 2018, P.934-935. (B)(4). THE REPORTED EVENTS OF OCULAR PAIN, VISION LOSS, EXPOSURE, OTHER-MEDICAL, HIGH INTRAOCULAR PRESSURE, ENDOPHTHALMITIS, INFLAMMATION/IRRITATION, AND USE ERROR ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. A REQUEST FOR FURTHER INFORMATION HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS. DEVICE LABELING: THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    REPORTED EVENTS OF PAIN, IRRITATION, SEVERELY REDUCED VISION, CORNEA WAS DIFFUSELY HAZY WITH +4 CELLS AND FIBRIN IN THE ANTERIOR CHAMBER, GROSSLY INJECTED BULBAR CONJUNCTIVA WITH BROKEN GEL STENT AND ONE OF THE ENDS HAD EXTRUDED THROUGH THE CONJUNCTIVA WITH IOP OF 44MMHG, AND ENDOPHTHALMITIS IN THE LEFT EYE WERE NOTED IN THE ARTICLE "ENDOPHTHALMITIS FOLLOWING XEN STENT EXPOSURE." JOURNAL OF GLAUCOMA, VOL. 27, NO. 10, OCTOBER 2018, P.931-933.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82380 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention