BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XEN 45 GTS

    MDR report key: 19689812 · Received July 8, 2024

    Report

    Report Number
    3011299751-2024-00099
    Event Type
    Injury
    Date Received
    July 8, 2024
    Date of Event
    May 17, 2024
    Report Date
    August 1, 2024
    Manufacturer
    ALLERGAN (IRVINE)
    Product Code
    KYF
    PMA / PMN Number
    K161457
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ARTICLE CITATION: RICARDO AUGUSTO PALETTA GUEDES, VANESSA MARIA PALETTA GUEDES AND DANIELA MARCELO GRAVINA ET AL. "REAL-WORLD INITIAL RESULTS OF THE XEN 45 GEL STENT IN THE BRAZILIAN POPULATION (RESULTADOS INICIAIS DE MUNDO REAL DO XEN 45 GEL STENT NA POPULAÇÃO BRASILEIRA)." REVISTA BRASILEIRA DE OFTALMOLOGIA. 2024. VOL. 83. DOI: 10.37039/1982.8551.20240025. 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.

    Additional Manufacturer Narrative · 0

    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

    THE ARTICLE "REAL-WORLD INITIAL RESULTS OF THE XEN 45 GEL STENT IN THE BRAZILIAN POPULATION" FROM THE JOURNAL REVISTA BRASILEIRA DE OFTALMOLOGIA REPORTED THE EVENTS OF "EYE DROPS REQUIRED IN UNKNOWN EYES" AND " 6 EYES HAD BLEB FAILURE REQUIRING SECONDARY SURGICAL INTERVENTION."

    Description of Event or Problem · 0

    IN THE ARTICLE, "REAL-WORLD INITIAL RESULTS OF THE XEN® 45 GEL STENT IN THE BRAZILIAN POPULATION" FROM THE JOURNAL REVISTA BRASILEIRA DE OFTALMOLOGIA, IT WAS REPORTED "ONE EYE EXPERIENCED CONJUNCTIVAL PERFORATION BY THE STENT DURING IMPLANTATION REQUIRING CONJUNCTIVA-TENON DISSECTION AND SUTURE; 6 EYES HAD FILTERING BLEB FAILURE, 5 EYES UNDERWENT UNSUCCESSFUL NEEDLING AND ALL 6 EYES REQUIRED OPEN SURGICAL REVISION VIA CONJUNCTIVA-TENON FLAP DISSECTION WITH MMC; AND AT FINAL VISIT 4 EYES REQUIRED ONE MEDICATION AND 2 EYES REQUIRED TWO MEDICATIONS." DEVICES REMAIN IMPLANTED. EVENTS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167645 XEN 45 GTS IMPLANT, EYE VALVE KYF ALLERGAN (IRVINE) NI

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention