BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK XEN STENT

    MDR report key: 15089424 · Received July 22, 2022

    Report

    Report Number
    3011299751-2022-00128
    Event Type
    Injury
    Date Received
    July 22, 2022
    Date of Event
    January 4, 2022
    Report Date
    August 11, 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

    IMPLANTATION NOTED BETWEEN (B)(6) 2016 AND (B)(6) 2020 ARTICLE CITATION: CAPPELLI F, CUTOLO CA,OLIVARI S, ET AL. "TRABECULECTOMYVERSUS XEN GEL IMPLANT FOR THE TREATMENT OF OPEN-ANGLE GLAUCOMA: A 3- YEAR RETROSPECTIVE ANALYSIS." BMJOPEN OPHTHALMOLOGY 2022, 7:E000830. DOI:10.1136/BMJOPHTH-2021-000830. 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. THIS IS A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Additional Manufacturer Narrative · 0

    AWARE DATE [PARENT] WAS INITIALLY SENT AS (B)(6) 2022. THE CORRECTED INITIAL AWARE DATE [PARENT] SHOULD BE (B)(6) 2022.

    Description of Event or Problem · 0

    REPORTED EVENTS OF 6 EYES WITH CHOROIDAL DETACHMENTS, 1 EYE POSITIVE SEIDEL TEST, 2 EYES WITH HYPHEMA, 2 EYES REQUIRED ND:YAG LASER SURGICAL TREATMENT TO RESTORE PATENCY, NEEDLING WAS REQUIRED AN AVERAGE OF 2.7 TIMES, 1 EYE REQUIRED BLEB REVISION, AND 7 EYES REQUIRED TRABECULECTOMY WERE NOTED IN THE ARTICLE, "TRABECULECTOMY VERSUS XEN GEL IMPLANT FOR THE TREATMENT OF OPEN-ANGLE GLAUCOMA: A 3-YEAR RETROSPECTIVE ANALYSIS." BMJ OPEN OPHTHALMOLOGY (2022); VOLUME 7.

    Description of Event or Problem · 0

    REPORTED EVENTS OF 6 EYES WITH CHOROIDAL DETACHMENTS, 1 EYE POSITIVE SEIDEL TEST, 2 EYES WITH HYPHEMA, 2 EYES REQUIRED ND:YAG LASER SURGICAL TREATMENT TO RESTORE PATENCY, NEEDLING WAS REQUIRED AN AVERAGE OF 2.7 TIMES, 1 EYE REQUIRED BLEB REVISION, AND 7 EYES REQUIRED TRABECULECTOMY WERE NOTED IN THE ARTICLE, "TRABECULECTOMY VERSUS XEN GEL IMPLANT FOR THE TREATMENT OF OPEN-ANGLE GLAUCOMA: A 3-YEAR RETROSPECTIVE ANALYSIS." BMJ OPEN OPHTHALMOLOGY (2022); VOLUME 7.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    103117 UNK XEN STENT IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention