BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS (AUSTRALIA)

    MDR report key: 13213928 · Received January 10, 2022

    Report

    Report Number
    3011299751-2022-00004
    Event Type
    Injury
    Date Received
    January 10, 2022
    Date of Event
    November 23, 2021
    Report Date
    July 18, 2022
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: LAUREN SARTOR; LUKE NORTHEY; MATTHEW WELLS; ANDREW WHITE. "BLEB THESIA FOLLOWING XEN® GEL STENT IMPLANT: REVISION TECHNIQUE USING FIBRIN GLUE." CLIN EXPERIMENT OPHTHALMOL, 49: 873-977. HTTPS://DOI.ORG/10.1111/CEO.14014. MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ALLERGAN HAS RECEIVED NO RESPONSE FROM THE AUTHORS.

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: SARTOR, LAUREN, ET AL. ¿MANAGEMENT OF BLEB DYSESTHESIA FOLLOWING SUBCONJUNCTIVAL MICRO INVASIVE GLAUCOMA SURGERY BY REVISION WITH FIBRIN GLUE.¿ CLINICAL & EXPERIMENTAL OPHTHALMOLOGY, VOL. 50, NO. 4, 2022, PP. 463¿64. CROSSREF, HTTPS://DOI.ORG/10.1111/CEO.14073. THIS IS THE SAME ARTICLE REPORTED UNDER MDR REPORT #3011299751-2022-00053 (ALLERGAN COMPLAINT #PR (B)(4)). THIS MDR IS BEING SUBMITTED TO CAPTURE THE SECOND PATIENT. THE REPORTED EVENTS OF "CATARACT PROGRESSION AND UVEITIS" ARE PHYSIOLOGICAL COMPLICATIONS AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ALLERGAN IN DETERMINING A PROBABLE CAUSE FOR THESE EVENTS.

    Description of Event or Problem · 0

    THE REPORTED EVENTS OF TWO PATIENTS EXPERIENCED A POST-OPERATIVE EVENT DESCRIBED AS "BLEB DYSESTHESIA." SECONDARY SURGERY OF BLEB REVISION WAS PERFORMED AND RESULTED IN EVENT RESOLUTION WERE NOTED IN THE ARTICLE: "BLEB THESIA FOLLOWING XEN® GEL STENT IMPLANT: REVISION TECHNIQUE USING FIBRIN GLUE." CLIN EXPERIMENT OPHTHALMOL, 49: 873-977.

    Description of Event or Problem · 0

    THROUGH AN UPDATED ARTICLE, "MANAGEMENT OF BLEB DYSESTHESIA FOLLOWING SUBCONJUNCTIVAL MICRO INVASIVE GLAUCOMA SURGERY BY REVISION WITH FIBRIN GLUE," IT WAS REPORTED PATIENT NOTED DISCOMFORT WITH AN OVERSIZED BLEB EXTENDING INTO THE MEDIAL PALPEBRAL FISSURE AT 6 WEEKS POST-OP. THE CDVA WAS REDUCED TO 6/120 DUE PROGRESSION OF A CATARACT. 5 MONTHS POST-OP, PATIENT UNDERWENT RIGHT EYE CATARACT SURGERY, INTRAOCULAR LENS IMPLANATION AND BLEB REVISION FOR MANAGEMENT OF CATARACT AND BLEB DYSESTHESIA. 6 WEEKS LATER, CDVA WAS 6/6, IOP WAS 15 MMHG WITHOUT IOP-LOWERING THERAPY, AND THERE WAS A REDUCTION IN DISCOMFORT. 11 MONTHS AFTER REVISION, PATIENT DEVELOPED RECURRENT ANTERIOR UVEITIS REQUIRING A TAPERING COURSE OF TOPICAL DEXAMETHASONE AND FIXED-COMBINATION OF BIMATOPROST-TIMOLOL. A MONTH LATER, INTRAOCULAR PRESSURE (IOP) WAS 14 MMHG AND CDVA 6/5. EVENTS RESOLVED. THIS IS THE SAME PATIENT WITH THE SAME EVENT PREVIOUSLY REPORTED UNDER MDR ID# 3011299751-2022-00054 (ALLERGAN COMPLAINT #PR (B)(4)).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713402 XEN 45 GTS (AUSTRALIA) IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Female Required Intervention