BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 8294864 · Received January 31, 2019

    Report

    Report Number
    3011299751-2019-00025
    Event Type
    Injury
    Date Received
    January 31, 2019
    Date of Event
    December 15, 2018
    Report Date
    March 29, 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 · 0

    A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY DEVIATIONS OR NON-CONFORMANCES ARE FOUND, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    REPORTED EVENTS OF DELAYED SUPRACHOROIDAL BLEEDING (SCH) AND POTENTIALLY "KISSING" CHOROIDAL TOUCH DUE TO SIGNIFICANT DELAYED SCH IN THE LEFT EYE WERE NOTED IN THE ARTICLE "MANAGING DELAYED SUPRACHOROIDAL HEMORRHAGE AFTER INSERTION OF XEN45 GLAUCOMA DEVICE." JOURNAL OF GLAUCOMA, DECEMBER 2018, P.1-11.

    Additional Manufacturer Narrative · 1

    STRINGA, FRANCESCO, ET AL. "MANAGING DELAYED SUPRACHOROIDAL HEMORRHAGE AFTER INSERTION OF XEN45 GLAUCOMA DEVICE." JOURNAL OF GLAUCOMA, DECEMBER 2018, P.1-11. THE EVENT OF CHOROIDAL HEMORRHAGE IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. 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 DELAYED SUPRACHOROIDAL BLEEDING (SCH) AND POTENTIALLY "KISSING" CHOROIDAL TOUCH DUE TO SIGNIFICANT DELAYED SCH IN THE LEFT EYE WERE NOTED IN THE ARTICLE "MANAGING DELAYED SUPRACHOROIDAL HEMORRHAGE AFTER INSERTION OF XEN45 GLAUCOMA DEVICE." JOURNAL OF GLAUCOMA, DECEMBER 2018, P.1-11.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88004 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) 61290

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention