BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 15170602 · Received August 4, 2022

    Report

    Report Number
    3011299751-2022-00133
    Event Type
    Injury
    Date Received
    August 4, 2022
    Date of Event
    July 6, 2022
    Report Date
    August 4, 2022
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    10888628032439
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IMPLANT DATE: AB INTERNO XEN 45 GEL STENT IMPLANTATION BETWEEN APRIL 2017 AND JANUARY 2019, AB EXTERNO XEN 45 GEL STENT IMPLANTATION BETWEEN JANUARY 2019 AND AUGUST 2019. ARTICLE CITATION: GALLARDO, MARK J., ET AL. ¿COMPARISON OF CLINICAL OUTCOMES FOLLOWING GEL STENT IMPLANTATION VIA AB-EXTERNO AND AB-INTERNO APPROACHES IN PATIENTS WITH REFRACTORY GLAUCOMA.¿ CLINICAL OPHTHALMOLOGY, VOL. VOLUME 16, 2022, PP. 2187¿97. CROSSREF, HTTPS://DOI.ORG/10.2147/OPTH.S354038. 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. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    REPORTED EVENTS OF AB EXTERNO IMPLANTATION APPROACH, STENT RELOADING INTO INJECTOR, HIGH INTRAOCULAR PRESSURE, USAGE OF MEDICATIONS, FIBROSIS OR BLEB FAILURE REQUIRING NEEDLING OR 5-FU INJECTIONS, NUMERICAL AND CLINICAL HYPOTONY, VISION REDUCTION OF 2 LINES OR MORE, HYPOTONY MACULOPATHY, OPTIC DISC EDEMA, SEROUS/HEMORRHAGIC CHOROIDAL EFFUSIONS, MIGRATED XEN, EXPOSED XEN, EXPOSED XEN, ENDOPHTHALMITIS, AND GEL STENT CURLING WERE NOTED IN THE ARTICLE: "COMPARISON OF CLINICAL OUTCOMES FOLLOWING GEL STENT IMPLANTATION VIA AB-EXTERNO AND AB-INTERNO APPROACHES IN PATIENTS WITH REFRACTORY GLAUCOMA" CLIN OPHTHALMOL. 16:2187-2197. THIS IS THE SAME ARTICLE REPORTED UNDER MDR ID #3011299751-2022-00134 (ALLERGAN COMPLAINT #(B)(4)). THIS MDR IS BEING SUBMITTED FOR THE MEDICAL EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1690624 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) 5513-001 NI 10888628032439

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female