BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 19510629 · Received June 11, 2024

    Report

    Report Number
    3011299751-2024-00090
    Event Type
    Injury
    Date Received
    June 11, 2024
    Date of Event
    May 21, 2024
    Report Date
    June 11, 2024
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    01240000000405
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION TO D.6A. IMPLANT DATE: (B)(6) 2022. ARTICLE CITATION: ELBABLY A, RICHARDSON-MAY J, AMERASINGHE N, IMONIKHE R, STRINGA F, SAMPATH S, JACOB A. XEN-DS: A NOVEL TECHNIQUE OF AB EXTERNO XEN IMPLANTATION AUGMENTED WITH A MODIFIED DEEP SCLERECTOMY FOR SURGICAL TREATMENT OF GLAUCOMA. EYE (LOND). 2024 MAY 21. DOI: 10.1038/S41433-024-03146-6. 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. THE EVENT OF HIGH INTRAOCULAR PRESSURE IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE, XEN-DS: A NOVEL TECHNIQUE OF AB EXTERNO XEN IMPLANTATION AUGMENTED WITH A MODIFIED DEEP SCLERECTOMY FOR SURGICAL TREATMENT OF GLAUCOMA, HEALTHCARE PROFESSIONAL REPORTED EVENTS OF "6 PATIENTS HAD PREVIOUS AB-EXTERNO XEN SURGERY WITH INADEQUATE REDUCTION IN IOP; WHICH WERE REPLACED DURING THE IMPLANTATION PROCEDURE OF THE STUDY. 20 PATIENTS UNDERWENT AB-EXTERNO XEN IMPLANTATION COMBINED WITH DEEP SCLERECTOMY IN UNKNOWN EYES. POST-OPERATIVELY, 7 EYES REQUIRED GLAUCOMA MEDICATION; 2 EYES REQUIRED REVISION SURGERY WITH XEN REPLACEMENT DUE TO BLOCKAGE OF THE ORIGINAL STENT; 4 EYES HAD CONGESTED BLEB; 1 EYE HAD TRANSIENT MICROHYPHEMA; 4 EYES HAD TRANSIENT LOW IOP (< 5 MMHG); 2 EYES HAD TRANSIENT CHOROIDAL EFFUSIONS." THIS IS THE SAME ARTICLE REPORTED UNDER PATIENT IDENTIFIER (B)(6) . THIS MDR IS BEING SUBMITTED FOR THE 20 PATIENTS WHO UNDERWENT AB-EXTERNO XEN IMPLANTATION COMBINED WITH DEEP SCLERECTOMY IN UNKNOWN EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1170614 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI 01240000000405

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention