BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 19810512 · Received July 23, 2024

    Report

    Report Number
    3011299751-2024-00105
    Event Type
    Injury
    Date Received
    July 23, 2024
    Date of Event
    July 4, 2024
    Report Date
    July 23, 2024
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    UDI-DI
    01240000000405
    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

    ARTICLE CITATION: CARASSA, R.G., CORSINI, G. & TRIOLO, G. LONG-TERM EFFECTIVENESS AND SAFETY OF XEN45 IN OPEN-ANGLE GLAUCOMA PATIENTS. INT OPHTHALMOL 44, 310 (2024). HTTPS://DOI.ORG/10.1007/S10792-024-03234-2. MULTIPLE REQUESTS FOR FURTHER INFORMATION HAVE BEEN MADE. ABBVIE HAS RECEIVED NO RESPONSE FROM THE AUTHORS. THE EVENT IS A PHYSIOLOGICAL COMPLICATION AND ANALYSIS OF THE DEVICE GENERALLY DOES NOT ASSIST ABBVIE IN DETERMINING A PROBABLE CAUSE FOR THIS EVENT. THE EVENTS ARE A KNOWN POTENTIAL ADVERSE EVENT ADDRESSED IN THE PRODUCT LABELING.

    Description of Event or Problem · 0

    REVIEW OF THE ARTICLE "LONG-TERM EFFICACY AND SAFETY OF XEN-45 GEL STENT IMPLANTATION IN PATIENTS WITH NORMAL-TENSION GLAUCOMA" FROM THE JOURNAL BMC OPHTHALMOLOGY NOTED THE FOLLOWING EVENTS "15 EYES HAD HYPHEMA; 13 EYES HAD TRACES OF BLOOD IN AC; 3 EYES HAD BLEB DYSESTHESIA; 6 EYES HAD XEN-IRIS CONTACT; 2 EYES HAD CHOROIDAL DETACHMENT; 2 EYES HAD XEN EXPOSURE; 1 EYE HAD HYPOTONY; 2 EYES HAD SHALLOW AC; 1 EYE HAD XEN OCCLUSION; 2 EYES HAD XEN REPOSITIONING; 4 EYES REQUIRED BLEB REVISION; 2 EYES HAD XEN RUPTURE; 1 EYE HAD ENDOPHTHALMITIS REQUIRING ENUCLEATION; 15 EYES REQUIRED ADDITIONAL SURGERY (5 EYES HAD MICROSHUNT IMPLANT; 5 EYES WITH NON-PENETRATING DEEP SCLERECTOMY; 2 EYES WITH GLAUCOMA DRAINAGE IMPLANT; 1 EYE HAD TRABECULECTOMY; 1 EYE HAD EXPRESS IMPLANT; 1 EYE HAD BLEB REVISION); 81 EYES REQUIRED NEEDLING; MEAN NUMBER OF OCULAR HYPOTENSIVE MEDICATIONS AT FINAL FOLLOW UP WAS 0.9 ± 1.3." DEVICE STATUS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2483368 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI 01240000000405

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Disability| R