BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 13515559 · Received February 11, 2022

    Report

    Report Number
    3011299751-2022-00034
    Event Type
    Injury
    Date Received
    February 11, 2022
    Date of Event
    June 13, 2019
    Report Date
    February 11, 2022
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    01240000000405
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE MEAN AGE WAS (B)(6) YEARS. IMPLANT DATES RANGE BETWEEN (B)(6) 2014 AND (B)(6) 2015. (B)(4). ARTICLE CITATION: HENGERER, FRITZ H ET AL. ¿COMPARISON OF MINIMALLY INVASIVE XEN45 GEL STENT IMPLANTATION IN GLAUCOMA PATIENTS WITHOUT AND WITH PRIOR INTERVENTIONAL THERAPIES.¿ OPHTHALMOLOGY AND THERAPY VOL. 8,3 (2019): 447-459. DOI:10.1007/S40123-019-0193-7. THE EVENT OF "HIGH INTRAOCULAR PRESSURE" IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE REPORTED EVENTS IN TWO GROUPS: ¿COMPARISON OF MINIMALLY INVASIVE XEN45 GEL STENT IMPLANTATION IN GLAUCOMA PATIENTS WITHOUT AND WITH PRIOR INTERVENTIONAL THERAPIES.¿ OPHTHALMOLOGY AND THERAPY VOL. 8,3. GROUP A: "13 EYES REQUIRED NEEDLING," "1 EYE EXPERIENCED HYPHEMA," "3 EYES REQUIRED A 2ND XEN45 GEL STENT," AND "1 EYE EXPERIENCED HYPOTONY AT 1 MONTH." GROUP B: "36 EYES REQUIRED NEEDLING," "1 EYE EXPERIENCED SUBCONJUNCTIVAL HEMORRHAGE INTRAOPERATIVELY," "8 EYES REQUIRED A 2ND XEN45 GEL STENT," AND "6 EYES EXPERIENCED HYPOTONY AT 1 MONTH, 2 OF THE EYES REQUIRED FILLING OF THE ANTERIOR CHAMBER." THIS IS THE SAME ARTICLE REPORTED UNDER MDR ID# 3011299751-2022-00033 (ALLERGAN COMPLAINT # (B)(4)). THIS MDR IS BEING SUBMITTED FOR GROUP B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91299 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI 01240000000405

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention ANTIGLAUCOMA MEDICATIONS