BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 10590787 · Received September 25, 2020

    Report

    Report Number
    2953161-2020-01023
    Event Type
    Injury
    Date Received
    September 25, 2020
    Date of Event
    September 2, 2020
    Report Date
    September 25, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    UDI-DI
    00733132618552
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUCTIONS FOR USE (IFU) FOR THE GORE® EXCLUDER® AAA ENDOPROSTHESIS STATES, ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO: ENDOPROSTHESIS: MIGRATION. IMAGES WERE PROVIDED TO GORE FOR EVALUATION AND SHOWED THE FOLLOWING: ONE TIME-POINT AVAILABLE FOR EVALUATION: POST-IMPLANTATION CTA DATED 2 SEP 2020. THE CONTRALATERAL LIMB APPEARS TO END WITHIN THE ANEURYSMAL PORTION OF THE PROXIMAL LCI, SO THERE IS LACK OF DEVICE APPOSITION IN THE LCI. THE LENGTH FROM THE DISTAL CONTRALATERAL LIMB TO THE LEFT ILIAC BIFURCATION APPEARS TO BE ~5.4CM, BY OUTER CURVE LENGTH. CANNOT CONFIRM MIGRATION WITH ONE TIME-POINT. THERE APPEARS TO BE 15MM OF SEAL ZONE IN THE DISTAL LCI WITH DIAMETERS RANGING FROM 12.8MM ¿ 18.7MM.

    Description of Event or Problem · 1

    ON SEPTEMBER 4, 2020, FOLLOW-UP IMAGES WERE PROVIDED TO THE FIELD SALES ASSOCIATE. THE PHYSICIAN REPORTS THAT THE CONTRALATERAL LIMB SEEMS TO BE SITTING UP A LITTLE HIGH AND MAY HAVE MIGRATED PROXIMALLY. NO OTHER ISSUES WERE REPORTED. ON (B)(6) 2020, THE PATIENT UNDERWENT REINTERVENTION AND THE CONTRALATERAL SIDE WAS IMPLANTED WITH AN ADDITIONAL CONTRALATERAL LEG COMPONENT TO PROVIDE ADDITIONAL COVERAGE TO THE COMMON ILIAC ARTERY DUE TO PROXIMAL MIGRATION OF INITIAL GRAFT UP WITHIN THE ANEURYSM SAC. THE PATIENT TOLERATED THE PROCEDURE WITH GOOD RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1051687 GORE EXCLUDER AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. PLC201400 00733132618552

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O| R