BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS - 3

    MDR report key: 9242407 · Received October 25, 2019

    Report

    Report Number
    2017233-2019-01090
    Event Type
    Injury
    Date Received
    October 25, 2019
    Date of Event
    November 23, 2018
    Report Date
    October 28, 2019
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE COMPLETED AS NO LOT NUMBER INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ADDITIONAL INFORMATION ABOUT THIS EVENT COULD NOT BE OBTAINED. AS A RESULT, NO CONCLUSION CAN BE DRAWN. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING.

    Description of Event or Problem · 1

    THE FOLLOWING ARTICLE WAS REVIEWED: "ENDOVASCULAR RECONSTRUCTION OF SUBCLAVIAN ARTERY ANEURYSMS IN PATIENTS WITH ATRIAL THORACIC OUTLET SYNDROME" (MEENA ARCHIE, M.D.; HUGH GELAGERT, M.D.; PRESENTED AT THE SOUTHERN CALIFORNIA VASCULAR SURGICAL SOCIETY 2018 MEETING IN LOS ANGELES; ANN VASC SURG 2019; 57: 10-15; PUBLISHED ONLINE: 23 NOVEMBER 2018) WAS REVIEWED. THE ARTICLE IDENTIFIES 1 PATIENT WHO HAD A HEMODYNAMICALLY SIGNIFICANT STENOSIS AT 26 MONTHS PER SURVEILLANCE ULTRASOUND. THE STENOSIS WAS TREATED WITH PACLITAXEL-COATED BALLOON ANGIOPLASTY. NOTE: BOTH WALLSTENT¿ ENDOPROSTHESIS (BOSTON SCIENTIFIC, NEWTON, MA) AND GORE® VIABAHN® ENDOPROSTHESIS (W.L.GORE, FLAGSTAFF, AZ) WERE IMPLANTED DURING THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033002 GORE VIABAHN ENDOPROSTHESIS - 3 NIP PFV W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention