BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 15210741 · Received August 11, 2022

    Report

    Report Number
    3011299751-2022-00138
    Event Type
    Injury
    Date Received
    August 11, 2022
    Date of Event
    July 14, 2022
    Report Date
    August 11, 2022
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    10888628032439
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ARTICLE CITATION: RUDA, RACHEL, ET AL. ¿CLINICAL OUTCOMES OF AB INTERNO PLACEMENT VERSUS AB EXTERNO PLACEMENT OF XEN 45 GEL STENTS.¿ OPHTHALMOLOGY GLAUCOMA, 2022 JUL 14:S2589-4196(22)00114-4. DOI: 10.1016/J.OGLA.2022.07.002. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 0

    REPORTED EVENTS OF: OFF-LABEL IMPLANTATION OF XEN®45 GTS VIA AB EXTERNO APPROACH IN 60 EYES, INTRAOCULAR PRESSURE HIGHER THAN 30 MMHG IN 9 EYES, HYPHEMA IN 6 EYES, CHOROIDAL EFFUSIONS IN 5 EYES, REBOUND IRITIS IN 4 EYES, IRIS OBSTRUCTION OF STENT IN 3 EYES, WOUND LEAK IN 2 EYES, HYPOTONY MACULOPATHY IN 2 EYES, XEN EROSION AND REMOVAL IN 1 EYE, CORNEAL DECOMPENSATION IN 1 EYE, SYMPTOMATIC BLEB EXTENSION IN 1 EYE, CYSTOID MACULAR EDEMA IN 1 EYE, CORNEAL ABRASION IN 1 EYE, BLEB NEEDLING IN 20 EYES, OPEN REVISION WITH TENONECTOMY IN UNKNOWN EYES, AND REPEAT XEN IMPLANT IN UNKNOWN EYES, WERE NOTED IN THE ARTICLE: "CLINICAL OUTCOMES OF AB INTERNO PLACEMENT VERSUS AB EXTERNO PLACEMENT OF XEN 45 GEL STENTS" OPHTHALMOLOGY GLAUCOMA (2022).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1721334 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) 5513-001 NI 10888628032439

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Disability| R