BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 9593207 · Received January 15, 2020

    Report

    Report Number
    3011299751-2020-00002
    Event Type
    Injury
    Date Received
    January 15, 2020
    Date of Event
    December 12, 2019
    Report Date
    January 15, 2020
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ARTICLE CITATION: GUPTA, C., MATHEWS, D. XEN® STENT COMPLICATIONS: A CASE SERIES. BMC OPHTHALMOL 19, 253 (2019) DOI:10.1186/S12886-019-1267-Y, PAGES 1-5. THE EVENT OF INCORRECT PLACEMENT 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 CORRESPONDING AUTHOR REGARDING THE EVENT, PRODUCT, AND PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    IN THE ARTICLE "XEN® STENT COMPLICATIONS: A CASE SERIES, BMC OPHTHALMOL 19, 253" IT WAS NOTED A PATIENT HAD COMBINED RIGHT EYE CATARACT SURGERY WITH XEN 45 GEL STENT INSERTION AND MMC. ONE DAY POST-OPERATIVELY IT WAS NOTED THAT THE TIP WAS TENTING BENEATH THE BLEB THEREFORE THE STENT WAS PULLED FROM THE SUBCONJUNCTIVAL END IN CLINIC. SEVERAL ATTEMPTS WERE MADE TO POSITION THE IMPLANT CORRECTLY AND ACHIEVE A 3MM LENGTH SUBCONJUNCTIVALLY. HOWEVER DURING MANIPULATION, IT WAS NOTED THAT THE IMPLANT HAD FRAGMENTED INTO MULTIPLE PIECES WITHIN THE SUBCONJUNCTIVA SPACE. THE PATIENT WAS LISTED FOR FURTHER XEN STENT AND MMC, WHICH WAS INSERTED ADJACENT TO THE INITIAL IMPLANT, WITH NO COMPLICATIONS. THE FRAGMENTED PIECES WERE NOT REMOVED. PATIENT REMAINS ON NO GLAUCOMA MEDICATIONS AND HAS MAINTAINED THEIR VISION AT - 0.06 LOGMAR AND IOP AT 12MMHG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56305 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other| R