BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 16844961 · Received May 1, 2023

    Report

    Report Number
    3011299751-2023-00079
    Event Type
    Injury
    Date Received
    May 1, 2023
    Date of Event
    April 25, 2018
    Report Date
    May 1, 2023
    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

    CONTINUED H.6. HEALTH EFFECT - IMPACT CODES: F2303, F2301. ARTICLE CITATION: LEE, IAN BS, ET AL. "SHORT-TERM OUTCOMES OF XEN 45 GEL STENT AB INTERNO VERSUS AB EXTERNO TRANSCONJUNCTIVAL APPROACHES." J GLAUCOMA. 2023 MAR 13. DOI: 10.1097/IJG.0000000000002208. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE EVENT IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A PATIENT WAS IMPLANTED WITH A XEN®45 GTS IN THE LEFT EYE. PATIENT WOULD HAVE A WOUND LEAKAGE ON POST OP DAY 1 THAT RESOLVED BY POST-OP WEEK 1. IT WAS NOTED ON POST OP WEEK 1, HOWEVER, THAT THE IRIS WAS PLUGGING THE XEN WITH AN IOP OF 34 AND SEVERE ENCAPSULATION. THIS REQUIRED A LASER IRIDOPLASTY. ON POST OP WEEK 2-3, PATIENT HAD AN IOP OF 20MMHG THAT REQUIRED STARTING OF 3 IOP MEDICATIONS. PATIENT ULTIMATELY WOULD HAVE AN IOP OF 51MMHG AROUND POST-OP MONTH 6-8 THAT WAS NOT CONTROLLED ON A TOTAL OF 4 IOP MEDICATIONS, REQUIRING PLACEMENT OF AN AHMED VALVE. DEVICE REMAINS IMPLANTED. THIS LITERATURE ARTICLE WAS PREVIOUSLY REPORTED UNDER MDR ID #3011299751-2023-00040. THIS MDR IS BEING SUBMITTED FOR SPECIFICALLY FOR THIS PATIENT THAT WAS ADDITIONALLY PROVIDED BY THE AUTHOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275192 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) 5513-001 NI 10888628032439

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention