BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 8662885 · Received June 3, 2019

    Report

    Report Number
    3011299751-2019-00109
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    April 10, 2019
    Report Date
    June 3, 2019
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY DEVIATIONS OR NON-CONFORMANCE ARE FOUND, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. CLARIFICATION TO SERIAL: SERIAL NUMBER (B)(4), LOT NUMBER 62318. THE EVENT OF DEVICE MIGRATION IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. FURTHER INFORMATION FROM THE REPORTER REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DEVICE LABELING: THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED THE XEN®45 GTS IS LONGER IN THE ANTERIOR CHAMBER (AC) AND UNDER THE CONJUNCTIVA 3 DAY POST-OP. THE XEN®45 GTS MIGRATED FURTHER AND ALMOST COMPLETELY IN THE AC BY DAY 5 POST-OP. DURING RE-POSITIONING THE STENT VIA AB-EXTERNO IN THE RIGHT EYE, ABOUT 1 MM OF THE STENT BROKE OFF. THE DEVICE WAS SUCCESSFULLY REPOSITIONED AND THE EVENT HAS BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456569 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DEXAMETHASONE AND CIPROFLOXACIN EYE DROPS.