BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 7465043 · Received April 26, 2018

    Report

    Report Number
    3011299751-2018-00053
    Event Type
    Injury
    Date Received
    April 26, 2018
    Date of Event
    March 15, 2018
    Report Date
    April 26, 2018
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT(S): PRED QID POST OP FOR 4 WEEKS; BID, AND QD. A REVIEW OF THE DEVICE HISTORY RECORD HAS BEEN INITIATED. IF ANY NEW, CHANGED OR CORRECTED INFORMATION IS NOTED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. SERIAL NUMBER (B)(4), LOT NUMBER 61779. THE REPORTED EVENTS OF HIGH INTRAOCULAR PRESSURE AND DEVICE MIGRATION ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. DEVICE LABELING: PRECAUTIONS; THE PATIENT¿S IOP SHOULD BE MONITORED POSTOPERATIVELY. IF THE IOP IS NOT ADEQUATELY MAINTAINED AFTER SURGERY, A THERAPEUTIC REGIMEN OR FURTHER INTERVENTION TO REDUCE IOP SHOULD BE CONSIDERED. WARNINGS: THE COMPLICATIONS THAT MAY OCCUR IN CONJUNCTION WITH THE USE OF THE XEN®45 GEL STENT INCLUDE, BUT ARE NOT LIMITED TO, CHOROIDAL EFFUSION, HYPHEMA, HYPOTONY, IMPLANT MIGRATION, IMPLANT EXPOSURE, WOUND LEAK, NEED FOR SECONDARY SURGICAL INTERVENTION AND OTHER KNOWN COMPLICATIONS OF INTRAOCULAR SURGERY (E.G., FLAT OR SHALLOW CHAMBER, CORNEAL EDEMA, ENDOPHTHALMITIS).

    Description of Event or Problem · 1

    HEALTHCARE PROFESSIONAL REPORTED AT 9-WEEK POST OP, IOP WAS AT 48 AND XEN RETRACTED ALL THE WAY BACK INTO THE LEFT EYE (IT WAS HANGING DOWN ACROSS THE ENTIRE ANTERIOR CHAMBER WITH ABOUT 1 MM LODGED STILL IN THE ANGLE). PATIENT WAS PUT ON COMBIGAN BID AND SCHEDULED 2 DAYS LATER FOR REMOVAL WITH TRABECULECTOMY. THE DEVICE HAS BEEN EXPLANTED AND TRABECULECTOMY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309454 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MAXITROL OINTMENT FOR 7 DAYS.