BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 17627775 · Received August 25, 2023

    Report

    Report Number
    3011299751-2023-00131
    Event Type
    Injury
    Date Received
    August 25, 2023
    Date of Event
    April 13, 2023
    Report Date
    August 25, 2023
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    10888628032439
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED E.1. FACILITY NAME: (B)(6). HEALTH EFFECT - IMPACT CODE: F2201, F1903, F1091. ARTICLE CITATION: LIN, BENJAMIN R ET AL. ¿ENDOPHTHALMITIS ASSOCIATED WITH XEN STENT IMPLANTATION.¿ AMERICAN JOURNAL OF OPHTHALMOLOGY VOL. 253 (2023): 37-43. DOI:10.1016/J.AJO.2023.04.006. 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 EVENTS ARE KNOWN POTENTIAL ADVERSE EVENTS ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    THROUGH JOURNAL ARTICLE TITLED ENDOPHTHALMITIS ASSOCIATED WITH XEN STENT IMPLANTATION, HEALTHCARE PROFESSIONAL REPORTED EVENT OF LEFT EYE "PATIENT UNDERWENT XEN45 IMPLANTATION COMBINED WITH CATARACT EXTRACTION WITH INTRAOCULAR LENS IMPLANTATION IN THE LEFT EYE. PATIENT PRESENTED ON POD131, 1 DAY AFTER ONSET OF SYMPTOMS (POD130), WITH BCVA OF HM, IOP OF 40 MMHG, CONJUNCTIVAL INJECTION, STENT EXPOSURE, HYPOPYON, CORNEAL EDEMA, AVASCULAR BLEB, AND SIGNIFICANT PURULENCE VIA SLIT-LAMP. VITREOUS CULTURE RESULTS WERE POSITIVE FOR STREPTOCOCCUS ORALIS AND STREPTOCOCCUS PSEUDOPORCINUS. PATIENT WAS DIAGNOSED WITH ENDOPHTHALMITIS AND RECEIVED INTRAVITREAL INJECTIONS OF VANCOMYCIN/CEFTAZIDIME ON POD131, VANCOMYCIN ON POD132 AND POD134, AND VANCOMYCIN/DEXAMETHASONE ON POD167 IN THE LEFT EYE. PPV WAS DELAYED 36 DAYS (POD167) AFTER PRESENTATION, BECAUSE OF THE IDENTIFICATION OF A POSSIBLE RETINAL DETACHMENT ON A FOLLOW-UP OCULAR ULTRASOUND. DURING THE PPV, IT WAS DETERMINED TO BE A PRERETINAL POST-INFLAMMATORY MEMBRANE. DEVICE WAS EXPLANTED. AT FINAL FOLLOW UP ON POD320, BCVA REMAINED AT HM AND IOP WAS 9 MMHG. THIS IS THE SAME ARTICLE REPORTED UNDER MDR REPORT # 3011299751-2023-00127 (ABBVIE COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR CASE 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2076750 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI 10888628032439

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention