BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 12206648 · Received July 21, 2021

    Report

    Report Number
    3011299751-2021-03045
    Event Type
    Injury
    Date Received
    July 21, 2021
    Date of Event
    June 4, 2021
    Report Date
    July 21, 2021
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ARTICLE CITATION: KIM, JAE GON, AND CHONG EUN LEE. ¿USE OF ND: YAG LASER TO RECANALIZE XEN GEL STENT OCCLUDED BY IRIS PIGMENT.¿ KOREAN JOURNAL OF OPHTHALMOLOGY, VOL. 35, NO. 3, 2021, PP. 242¿43. CROSSREF, DOI:10.3341/KJO.2021.0002. FURTHER INFORMATION FROM THE AUTHOR REGARDING EVENT, PRODUCT, OR PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS A KNOWN ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    THE ARTICLE, "USE OF ND: YAG LASER TO RECANALIZE XEN GEL STENT OCCLUDED BY IRIS PIGMENT" REPORTED A PATIENT HAD A XEN®45 GTS IMPLANTED IN THE LEFT EYE. TWO MONTHS POSTOPERATIVELY, INTRAOCULAR PRESSURE (IOP) INCREASED TO 20 MMHG. NEEDLING PROCEDURE PERFORMED AND IOP DECREASED TO 12 MMHG. FIVE MONTHS POSTOPERATIVELY, IOP INCREASED TO 22 MMHG. TREATMENT WAS NOTED AS A DIGITAL OCULAR COMPRESSION PERFORMED WITHOUT SUCCESS. 3+ CELL WAS SEEN IN THE AC (MOSTLY IRIS PIGMENT) WITH SLIT-LAMP AND ANTERIOR SEGMENT OPTICAL COHERENCE TOMOGRAPHY SHOWED SUSPECTED GEL STENT BLOCKAGE AT THE PROXIMAL (AC SIDE). AC IRRIGATION AND PROPHYLACTIC BLEB NEEDLING WITH SUBCONJUNCTIVAL 5-FLUOROURACIL INJECTION WAS PERFORMED WITHOUT SUCCESS. FINALLY, ND: YAG LASER ABLATION TO THE PROXIMAL END WAS PERFORMED TO REOPEN THE LUMEN AND IOP DECREASED TO 10 MMHG. IOP REMAINED STABLE 5 MONTHS AFTERWARDS. EVENT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1100548 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention