BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 15900764 · Received December 1, 2022

    Report

    Report Number
    3011299751-2022-00195
    Event Type
    Injury
    Date Received
    December 1, 2022
    Date of Event
    November 2, 2022
    Report Date
    December 5, 2022
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    01240000000405
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: SEO, J. H., LIM, S. H. "MANAGEMENT OF XEN GEL STENT EXPOSURE WITH CONJUNCTIVAL EROSION VIA ROTATIONAL CONJUNCTIVAL FLAP AND AMNIOTIC MEMBRANE TRANSPLANTATION - A CASE REPORT." MEDICINA. 2022 NOV 2;58(11):1581. DOI: 10.3390/MEDICINA58111581. PMID: 36363538. 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.

    Description of Event or Problem · 0

    REPORTED EVENTS OF POSTOPERATIVELY, PATIENT EXPERIENCED AVASCULAR BLEB, PERIOCULAR PAIN, VISUAL ACUITY DETERIORATION FROM 20/50 TO 20/100, WEAKLY POSITIVE SEIDEL TEST, AND A SMALL DEFECT IN THE CONJUNCTIVA LEADING TO CONJUNCTIVAL EROSION OF THE STENT (EROSION OCCURRED AT POM18). TOPICAL ANTIBIOTICS, LUBRICANTS, AND AUTOLOGOUS SERUM EYE DROPS WERE PROVIDED TO FACILITATE WOUND HEALING. HOWEVER, MEDICAL TREATMENT WAS UNSUCCESSFUL AND SURGICAL BLEB REVISION WAS PERFORMED; ROTATION OF CONJUNCTIVAL FLAP WITH AMNIOTIC MEMBRANE TRANSPLANT TO RESOLVE THE EROSION. 3 MONTHS AFTER REVISION, IOP IS STABLE AT 15 MMHG WITH USE OF LATANOPROST MEDICATION. AT 6 MONTHS AFTER REVISION, VISUAL FIELD WAS STABLE WITHOUT PROGRESSION. THE EVENTS OF EXPOSURE AND BLEB LEAKAGE HAVE RESOLVED; WERE NOTED IN THE ARTICLE: "MANAGEMENT OF XEN GEL STENT EXPOSURE WITH CONJUNCTIVAL EROSION VIA ROTATIONAL CONJUNCTIVAL FLAP AND AMNIOTIC MEMBRANE TRANSPLANTATION-A CASE REPORT." MEDICINA (KAUNAS). 2022 NOV 2;58(11):1581.

    Description of Event or Problem · 0

    REPORTED EVENTS OF POSTOPERATIVELY, PATIENT EXPERIENCED AVASCULAR BLEB, PERIOCULAR PAIN, VISUAL ACUITY DETERIORATION FROM 20/50 TO 20/100, WEAKLY POSITIVE SEIDEL TEST, AND A SMALL DEFECT IN THE CONJUNCTIVA LEADING TO CONJUNCTIVAL EROSION OF THE STENT (EROSION OCCURRED AT POM18). TOPICAL ANTIBIOTICS, LUBRICANTS, AND AUTOLOGOUS SERUM EYE DROPS WERE PROVIDED TO FACILITATE WOUND HEALING. HOWEVER, MEDICAL TREATMENT WAS UNSUCCESSFUL AND SURGICAL BLEB REVISION WAS PERFORMED; ROTATION OF CONJUNCTIVAL FLAP WITH AMNIOTIC MEMBRANE TRANSPLANT TO RESOLVE THE EROSION. 3 MONTHS AFTER REVISION, IOP IS STABLE AT 15 MMHG WITH USE OF LATANOPROST MEDICATION. AT 6 MONTHS AFTER REVISION, VISUAL FIELD WAS STABLE WITHOUT PROGRESSION. THE EVENTS OF EXPOSURE AND BLEB LEAKAGE HAVE RESOLVED; WERE NOTED IN THE ARTICLE: "MANAGEMENT OF XEN GEL STENT EXPOSURE WITH CONJUNCTIVAL EROSION VIA ROTATIONAL CONJUNCTIVAL FLAP AND AMNIOTIC MEMBRANE TRANSPLANTATION-A CASE REPORT." MEDICINA (KAUNAS). 2022 NOV 2;58(11):1581.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2329162 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI 01240000000405

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention| S