BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 13252645 · Received January 13, 2022

    Report

    Report Number
    3011299751-2022-00005
    Event Type
    Injury
    Date Received
    January 13, 2022
    Date of Event
    December 27, 2021
    Report Date
    January 13, 2022
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ARTICLE CITATION: TATTI, FILIPPO, ET AL. ¿XEN45 GEL STENT AB INTERNO TRIMMING FOR OSTIUM OCCLUSION: CASE REPORT.¿ BMC OPHTHALMOLOGY, VOL. 21, NO. 1, 2021. CROSSREF, DOI:10.1186/S12886-021-02207-8. 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. THESE ARE KNOWN POTENTIAL ADVERSE EVENTS ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    THE ARTICLE "XEN45 GEL STENT AB INTERNO TRIMMING FOR OSTIUM OCCLUSION: CASE REPORT" NOTED A PATIENT UNDERWENT A XEN®45 GTS IMPLANTATION IN THE RIGHT EYE AND WAS TREATED WITH ANTIBIOTICS AND TOPICAL CORTICOIDS IN A DECREASING DOSAGE FOR ONE MONTH. IOP WAS 6MMHG POST OP DAY 1 AND 10MMHG POST OP DAY 15. ONE MONTH AFTER THE XEN®45 GTS IMPLANTATION, PATIENT RETURNED FOR RETINAL SURGERY IN THE RIGHT EYE TO CLOSE A PRE-EXISTING MACULAR HOLE. OPERATION WAS SUCCESSFUL, HOWEVER 6 DAYS LATER, PATIENT'S IOP SPIKED TO 25MMHG AND EXAMINATION SHOWED A FLATTENING OF THE CONJUNCTIVAL BLEB AND A TRANSLUCENT CLOT OF FIBRIN OCCLUDING THE END OF THE XEN GEL STENT. A YAG LASER PROCEDURE WAS ATTEMPTED, BUT THE STENT REMAINED OCCLUDED AND IOP REMAINED ELEVATED. A REVISION PROCEDURE OF THE XEN 45 GEL STENT WAS PERFORMED AND REMOVAL OF THE FIBRIN WAS ATTEMPTED WHICH FAILED AS THE CLOT WAS STRONGLY ADHERENT TO THE TUBE END. A SECOND PARACENTESIS SITE WAS CREATED AND CURVED SCISSORS WERE USED TO THE SNIP THE PROXIMAL END OF THE XEN STENT. AFTER PROCEDURE, THE DRAINAGE EFFICIENCY WAS VERIFIED AND INCISIONS WERE CLOSED. POST OP DAY 1 AFTER THE PROCEDURE, THE IOP WAS 8MMHG AND A FUNCTIONAL, FILTERING BLEB WAS CONFIRMED. ONE MONTH POST OP, IOP WAS 12, VISUAL ACUITY WAS 20/40, AND AN OPEN, DIFFUSE, FILTERING BLEB WAS PRESENT. EVENTS RESOLVED AND THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785355 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention