BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK XEN STENT

    MDR report key: 12869960 · Received November 24, 2021

    Report

    Report Number
    3011299751-2021-03095
    Event Type
    Injury
    Date Received
    November 24, 2021
    Date of Event
    July 24, 2021
    Report Date
    November 24, 2021
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    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

    (B)(4). ARTICLE CITATION: SCHELLHASE, HANNAH, ET AL. ¿FAILURE OF XEN GEL STENT IMPLANTATION AS A STAND-ALONE PROCEDURE IN CONGENITAL GLAUCOMA: CASE REPORT OF SECONDARY CONGENITAL GLAUCOMA IN NEUROFIBROMATOSIS TYPE 1.¿ CASE REPORTS IN OPHTHALMOLOGICAL MEDICINE, VOLUME 2021, 24 JUL 2021, PP. 1¿4. CROSSREF, DOI:10.1155/2021/9947167. THE REPORTER HAS DECLINED TO PROVIDE ALLERGAN FURTHER INFORMATION REGARDING EVENT, PRODUCT, OR PATIENT DETAILS. THE EVENTS OF VISION LOSS, AND HIGH INTRAOCULAR PRESSURE ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS. EVENTS OF HIGH INTRAOCULAR PRESSURE AND DEVICE MIGRATION ARE KNOWN ADVERSE EVENTS ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    THE ARTICLE "FAILURE OF XEN GEL STENT IMPLANTATION AS A STAND-ALONE PROCEDURE IN CONGENITAL GLAUCOMA: CASE REPORT OF SECONDARY CONGENITAL GLAUCOMA IN NEUROFIBROMATOSIS TYPE 1" NOTED A PATIENT HAD AN UNKNOWN XEN GTS IMPLANTED IN THE LEFT EYE. ONE MONTH POST-OP, STENT WAS REPELLED INTO THE ANTERIOR CHAMBER DUE TO THE ELASTICITY OF TENON¿S LAYER. REVISION SURGERY PERFORMED WITH EXCISION OF TENON'S LAYER BUT UNSUCCESSFUL. THE FIRST DEVICE WAS REMOVED AND REPLACED WITH A 2ND XEN. 5 MONTH AFTER 2ND IMPLANT, A 2ND REVISION SURGERY WAS PERFORMED DUE TO AN ENCAPSULATED TENON CYST WITH INSUFFICIENT INTRAOCULAR PRESSURE (IOP) CONTROL. HOWEVER, WHILE REMOVING THE SCARRING TENON¿S LAYER, THE IMPLANT WAS DISLOCATED COMPLETELY INTO THE ANTERIOR CHAMBER. SIX MONTHS AFTER IMPLANTATION, THE STENT WAS STILL HIGHLY MOBILE INSIDE THE SCLERA. ANOTHER XEN GEL STENT (THE THIRD XEN GEL STENT) WAS IMPLANTED. AT THAT TIME, A PROGRESSIVE UPPER EYELID SWELLING WAS APPARENT AND SO AN EYELID HISTOPATHOLOGICAL BIOPSY LED TO THE DIAGNOSIS OF NEUROFIBROMATOSIS TYPE 1, DEEMED NOT RELATED TO THE DEVICE. IOP WAS UNDER CONTROL FOR ANOTHER 6 MONTHS WITH MEDICATION USE BUT WAS THEN FOUND AGAIN TO BE ELEVATED TO 32 MMHG. LASER CILIODESTRUCTIVE PROCEDURE WAS PERFORMED. LOSS OF LIGHT PERCEPTION WAS NOTED DURING CHEMOTHERAPY. AT LAST FOLLOW-UP, IOP WAS 28 MMHG UNDER MEDICATION. THIS IS THE SAME ARTICLE REPORTED UNDER MDR ID# 3011299751-2021-03079 (ALLERGAN COMPLAINT #PR (B)(4) AND 3011299751-2021-03087 (ALLERGAN COMPLAINT #PR (B)(4). THIS MDR IS BEING SUBMITTED FOR THE 2ND DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769067 UNK XEN STENT IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Female Required Intervention| S TRAVOPROST AND DORZOLAMIDE-TIMOLOL