BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 8786468 · Received July 12, 2019

    Report

    Report Number
    3011299751-2019-00164
    Event Type
    Injury
    Date Received
    July 12, 2019
    Date of Event
    June 13, 2019
    Report Date
    July 12, 2019
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    KALINA, A. G., P. H. KALINA, AND M. M. BROWN. "XEN® GEL STENT IN MEDICALLY REFRACTORY OPEN-ANGLE GLAUCOMA: RESULTS AND OBSERVATIONS AFTER ONE YEAR OF USE IN THE UNITED STATES." OPHTHALMOL THER, JUNE 2019, PG. 1-12, DOI.ORG/10.1007/S40123-019-0192-8. (B)(4). THE REPORTED EVENTS OF CHOROIDAL HEMORRHAGE, IRIDO-CORNEAL TOUCH, CHOROIDAL EFFUSION, HYPOTONY, FIBROSIS AND HIGH INTRAOCULAR PRESSURE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. MULTIPLE REQUESTS 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 "NON-EXPULSIVE CHOROIDAL HEMORRHAGE, SLIGHTLY SHALLOW ANTERIOR CHAMBER, SHALLOW SEROUS CHOROIDALS, HYPOTONY, NEEDLING PROCEDURE AND TRABECULECTOMY WERE PERFORMED IN THE UNKNOWN EYES" WERE NOTED IN THE ARTICLE: "XEN® GEL STENT IN MEDICALLY REFRACTORY OPEN-ANGLE GLAUCOMA: RESULTS AND OBSERVATIONS AFTER ONE YEAR OF USE IN THE UNITED STATES." AFFECTED SIDES/EYES UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578424 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention