BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 16950044 · Received May 17, 2023

    Report

    Report Number
    3011299751-2023-00084
    Event Type
    Injury
    Date Received
    May 17, 2023
    Report Date
    August 10, 2023
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    01240000000405
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE ANALYSIS: THE GEL STENT WAS PLACED ON A SLIDE AND HYDRATED. THE GEL STENT WAS AMBER IN COLOR. THE INNER CHANNEL OF THE GEL STENT APPEARED CLEAR OF DEBRIS AND UNOBSTRUCTED. ONE END OF THE STENT WAS OBSERVED TO BE FLUSH AND INTACT, WHILE THE OTHER END APPEARED JAGGED AND DAMAGED. LENGTH MEASUREMENT OF THE GEL STENT WAS OBTAINED. BASED ON LENGTH MEASUREMENTS OBTAINED, IT WAS DETERMINED A PORTION OF THE GEL STENT WAS BROKEN OFF AND NOT RETURNED. SINCE A PORTION OF THE GEL STENT WAS RETURNED, A VISUAL INSPECTION OF THE GEL STENT¿S ENTIRE INNER CHANNEL AND PROPER EVALUATION OF THE REPORTED COMPLAINT CONDITION CANNOT BE PERFORMED. THE REPORTED COMPLAINT OF GEL STENT BLOCKAGE IS UNABLE TO CONFIRM SINCE IT WAS DETERMINED THE GEL STENT WAS DAMAGED PRIOR TO SAMPLE RECEIPT AND ONLY A PORTION OF THE GEL STENT WAS RETURNED; THEREFORE, A VISUAL INSPECTION OF THE GEL STENT¿S ENTIRE INNER CHANNEL AND PROPER EVALUATION OF THE REPORTED COMPLAINT CONDITION CANNOT BE PERFORMED. IT IS UNKNOWN HOW THE GEL STENT BECAME DAMAGED; HOWEVER, THE DEVICE WAS REMOVED FROM THE TRAY AND MANIPULATED PRIOR TO RECEIPT; THEREFORE, HANDLING CANNOT BE RULED OUT. NO FURTHER EVALUATION IS REQUIRED.

    Additional Manufacturer Narrative · 0

    FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN COMPLETED. NO DEVIATIONS OR NON-CONFORMANCES NOTED.

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A XEN® GTS EVENT DESCRIBED AS "[XEN] WAS CLOGGED".

    Description of Event or Problem · 0

    HEALTHCARE PROFESSIONAL REPORTED A XEN® GTS EVENT DESCRIBED AS "[XEN] WAS CLOGGED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1696546 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) 63565 01240000000405

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown