BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 18066866 · Received November 3, 2023

    Report

    Report Number
    3011299751-2023-00173
    Event Type
    Injury
    Date Received
    November 3, 2023
    Date of Event
    October 19, 2023
    Report Date
    November 3, 2023
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    01240000000405
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUED H.6. HEALTH EFFECT - IMPACT CODES: F22. ARTICLE CITATION: ZHANG, YAO, ET AL. ¿RECANALIZATION OF XEN45 GEL STENT IMPLANT OCCLUSION USING 10 - 0 NYLON SUTURE IN REFRACTORY GLAUCOMA: A CASE REPORT.¿ BMC OPHTHALMOLOGY, VOL. 23, NO. 1, HTTPS://DOI.ORG/10.1186/S12886-023-03109-7. FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THE EVENT IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    REPORTED EVENTS OF "PATIENT UNDERWENT XEN®45 GTS AB-INTERNO IMPLANTATION IN THE RIGHT EYE. POD1, IOP WAS 5 MMHG WITH A CHOROIDAL DETACHMENT. POD5, IOP WAS 10 MMHG WITH A DIFFUSE BLEB AND CHOROIDAL DETACHMENT HAD RESOLVED. POD6, IOP WAS 40 MMHG AND MATERIAL OCCLUDING THE INTERNAL OSTIUM OF THE STENT. POD12, ND:YAG LASER SHOCKWAVE THERAPY WAS PERFORMED, RESULTING IN AN IOP DECREASE FROM 42 MMHG TO 25 MMHG AND OCCLUSION RESOLVED. THEN 6 HOURS LATER, IOP INCREASED TO 40 MMHG AND MULTIPLE ROUNDS OF SHOCKWAVE THERAPY WITH INCREASING INTENSITY WERE PERFORMED, BUT OCCLUSION REMAINED. IOP REMAINED SIGNIFICANTLY ELEVATED. POD14, REVISION SURGERY WAS PERFORMED VIA CONJUNCTIVAL INCISION WITH FIBROTIC REMOVAL, BUT NO FLOW WAS OBSERVED; FURTHER RECANALIZATION WAS PERFORMED VIA A 10-0 NYLON SUTURE TO THREAD THE STENT RESULTING IN IMMEDIATE FLOW OF AQUEOUS HUMOR AND RESOLVING THE OCCLUSION. POD15, IOP WAS 8 MMHG WITH A FILTERING BLEB. POD21, IOP WAS 10 MMHG, AND REMAINED AT 12 MMHG THROUGH POM6. AT POM11.5, IOP WAS 15 MMHG WITHOUT MEDICATION." WERE NOTED IN THE ARTICLE: "RECANALIZATION OF XEN45 GEL STENT IMPLANT OCCLUSION USING 10¿-¿0 NYLON SUTURE IN REFRACTORY GLAUCOMA: A CASE REPORT." BMC OPHTHALMOL. 2023 OCT 19;23(1):418.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2221577 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI 01240000000405

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Required Intervention