BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 16274820 · Received January 31, 2023

    Report

    Report Number
    3011299751-2023-00016
    Event Type
    Injury
    Date Received
    January 31, 2023
    Date of Event
    December 20, 2022
    Report Date
    January 31, 2023
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    01240000000405
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ARTICLE CITATION: VIEIRA R, LEITE J, FIGUEIREDO A, REIS R, SAMPAIO I, MENÉRES MJ. "XEN GEL STENT IMPLANTATION IN EYES WITH PREVIOUS GLAUCOMA FILTERING SURGERIES: A CASE SERIES. CUREUS. 2022 DEC 20;14(12):E32741. DOI: 10.7759/CUREUS.32741. PMID: 36686077; PMCID: PMC9851164. 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

    REPORTED EVENTS OF "INTRAOCULAR PRESSURES (IOP) OF 22, 24, AND 21 AT THE FIRST, THIRD, AND SIXTH MONTH OF FOLLOW UP, RESPECTIVELY. HIGH IOP TREATED WITH HYPOTENSIVE EYEDROPS, ONE EYE WITH PROSTAGLANDIN ANALOGS (PG) SPECIFICALLY. ONE EYE SHOWED SUSTAINED OCULAR HYPERTENSION (OHT) SINCE THE 1ST POSTOPERATIVE MONTH WITH TOPICAL MEDICATION, AND UNDERWENT AN EXPRESS IMPLANT 3 MONTHS AFTER XEN IMPLANTATION. ONE PATIENT SHOWED OHT 3 MONTHS AFTER IMPLANT, A FLAT BLEB WAS OBSERVED ON BIOMICROSCOPY, AND TOPICAL PG AND OCULAR MASSAGES WERE RECOMMENDED; 6 MONTHS AFTER IMPLANT, THE PATIENT WAS TAKEN TO SURGERY WHERE A NONFUNCTIONING OBSTRUCTED DEVICE WAS OBSERVED AND A SECOND XEN® GEL STENT WAS IMPLANTED." WERE NOTED IN THE ARTICLE: XEN GEL STENT IMPLANTATION IN EYES WITH PREVIOUS GLAUCOMA FILTERING SURGERIES: A CASE SERIES. CUREUS. (B)(6) 2022;14(12).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    896098 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI 01240000000405

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention