BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 12593937 · Received October 7, 2021

    Report

    Report Number
    3011299751-2021-03122
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    September 15, 2021
    Report Date
    October 7, 2021
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CLARIFICATION: MEAN AGE WAS 74.5 ± 7.6 YEARS. CLARIFICATION: IMPLANT DATES RANGED FROM MAY 2017 THROUGH JANUARY 2019. (B)(4). ARTICLE CITATION: SHARPE, ROBERT ET AL. ¿COMPARISON OF AB INTERNO XEN GELATIN STENT VS TRABECULECTOMY WITH MITOMYCIN C: A RETROSPECTIVE STUDY.¿ JOURNAL OF CURRENT GLAUCOMA PRACTICE VOL. 14,3 (2020): 87-92. DOI:10.5005/JP-JOURNALS-10078-1287. THE EVENTS OF "BLEBITIS 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. REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS AT THIS TIME.

    Description of Event or Problem · 1

    REPORTED EVENTS OF "27 EYES UNDERWENT NEEDLING," "7 EYES REQUIRED ADDITIONAL SURGERY," "1 EYE EXPERIENCED BLEB LEAK," "1 EYE EXPERIENCES SHALLOW/FLAT AC," "12 EYES EXPERIENCED TRANSIENT, SELF-RESOLVING HYPHEMA," AND "1 EYE EXPERIENCES BLEBITIS" WERE NOTED IN THE ARTICLE: ¿COMPARISON OF AB INTERNO XEN GELATIN STENT VS TRABECULECTOMY WITH MITOMYCIN C: A RETROSPECTIVE STUDY.¿ JOURNAL OF CURRENT GLAUCOMA PRACTICE. VOL. 14(3); 87-92.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1490414 XEN 45 GTS IMPLANT, EYE VALVE KYF NI

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention