BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 8964968 · Received September 5, 2019

    Report

    Report Number
    3011299751-2019-00236
    Event Type
    Injury
    Date Received
    September 5, 2019
    Date of Event
    October 24, 2018
    Report Date
    September 5, 2019
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ARTICLE CITATION: AYESHA KARIMI, DAN LINDFIELD, ANDREW TURNBULL, CHRYSOSTOMOS DIMITRIOU, BHAIRAVI BHATIA, MAHMOUD RADWAN, PIETER GOUWS, ABDUL HANIFUDIN, NISHANI AMERASINGHE, & ABY JACOB. "A MULTI-CENTRE INTERVENTIONAL CASE SERIES OF 259 AB-INTERNO XEN GEL IMPLANTS FOR GLAUCOMA, WITH AND WITHOUT COMBINED CATARACT SURGERY." THE ROYAL COLLEGE OF OPHTHALMOLOGISTS 2018, EYE (2019) 33:469¿477 HTTPS://DOI.ORG/10.1038/S41433-018-0243-8. THE REPORTED EVENTS OF HYPOTONY MACULOPATHY, BLEB-RELATED LEAKAGE, HIGH INTRAOCULAR PRESSURE, VISION LOSS, EXPOSURE, ENDOPHTHALMITIS, LOW INTRAOCULAR PRESSURE, BLEB-RELATED ISSUES, BLEB-RELATED LEAKAGE, CHOROIDAL EFFUSION, CENTRAL RETINAL VEIN OCCLUSION AND A CYCLODIALYSIS CLEFT ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. FURTHER INFORMATION FROM THE AUTHOR REGARDING THE EVENTS, PRODUCTS, AND PATIENT DETAILS HAS BEEN REQUESTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. DEVICE LABELING: THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 1

    REPORTED EVENTS OF HYPOTONY, IOP SPIKE, TRANSIENT XEN OCCLUSION, LESS THAN 2 SNELLEN LINES VISON LOSS LASTING MORE THAN ONE MONTH, LARGE DYAESTHETIC BLEB, EXPOSURE, HYPOTONOUS MACULOPATHY, CHOROIDAL EFFUSION, ENDOPHTHALMITIS, CENTRAL RETINAL VEIN OCCLUSION AND CYCLODIALYSIS CLEFT WERE NOTED IN THE ARTICLE: "A MULTI-CENTRE INTERVENTIONAL CASE SERIES OF 259 AB-INTERNO XEN GEL IMPLANTS FOR GLAUCOMA, WITH AND WITHOUT COMBINED CATARACT SURGERY." IN TOTAL, 259 CONSECUTIVE SURGERIES OF 226 PATIENTS WERE REVIEWED. IN ALL, 40.9% OF CASES REQUIRED POSTOPERATIVE BLEB NEEDLING OR ANTIMETABOLITE INJECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760469 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention