BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN GEL STENT

    MDR report key: 20172491 · Received September 6, 2024

    Report

    Report Number
    MW5159350
    Event Type
    Injury
    Date Received
    September 6, 2024
    Date of Event
    August 31, 2023
    Report Date
    September 4, 2024
    Manufacturer
    ALLERGAN SALES, LLC
    Product Code
    KYF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE XEN GEL STENT WAS SURGICALLY IMPLANTED IN THE LEFT EYE FOR THE TREATMENT OF GLAUCOMA. THE EYE HAD 20/20 VISION PRIOR TO THE SURGERY. THE PROCEDURE RESULTED IN TOTAL BLINDNESS IN THE EYE UPON WAKING FROM SURGICAL ANESTHESIA. IT APPEARS THE BLINDNESS WAS CAUSED BY THE MITOMYCIN IMBEDDED IN THE STENT, WHICH CAUSED THE CILIARY BODY WITHIN THE EYE TO SHUT DOWN. THIS CAUSED ZERO EYE PRESSURE AND BLINDNESS. SUBSEQUENT EFFORTS TO FLUSH THE MITOMYCIN AND RESTORE EYE PRESSURE WITH GAS AND THEN SILICONE WERE NOT SUCCESSFUL. IT WAS HOPED THAT THE CILIARY BODY WOULD ITSELF RESUME FUNCTION WITHIN A YEAR'S TIME. THAT DID NOT HAPPEN. OPHTHALMOLOGIC CONSULTATION LOCALLY AND SEPARATELY AT MASS GENERAL DID NOT OFFER ADDITIONAL TREATMENT OPTIONS. PICTURES OF THE PATIENT IMPLANT CARD WERE SENT TO (B)(4) OF THE FDA SEPARATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329923 XEN GEL STENT IMPLANT, EYE VALVE KYF ALLERGAN SALES, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R| S| H