BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN® ENDOPROSTHESIS

    MDR report key: 4954858 · Received July 30, 2015

    Report

    Report Number
    2017233-2015-00483
    Event Type
    Injury
    Date Received
    July 30, 2015
    Date of Event
    April 22, 2014
    Report Date
    August 26, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    JCT
    PMA / PMN Number
    K013648
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS NO LOT NUMBER INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED. CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. ALL INFORMATION HAS BEEN PLACED ON FILE FOR USE IN TRACKING AND TRENDING. DATE WHEN THE ARTICLE WAS ACCEPTED ((B)(6) 2014) HAS BEEN USED AS THE DATE THE INCIDENT OCCURRED.

    Description of Event or Problem · 1

    THE RETROSPECTIVE ARTICLE, ¿ENDOVASCULAR TREATMENT OF POPLITEAL ARTERY ANEURYSM. EARLY AND MIDTERM RESULTS¿ (REV. COL. BRAS. CIR. 2015; 42(1): 037-041) WAS REVIEWED. OVER A SIX YEAR PERIOD, ENDING IN 2012, THE GORE VIABAHN® ENDOPROSTHESIS WAS IMPLANTED IN 12 CASES FOR ENDOVASCULAR REPAIR OF POPLITEAL ARTERY ANEURYSMS. IT WAS REPORTED IN THE ARTICLE THAT ONE PATIENT DEVELOPED ACUTE ARTERIAL OBSTRUCTION ON THE FIRST DAY AFTER SURGERY AND WAS TREATED SUCCESSFULLY WITH THROMBOLYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496155 GORE VIABAHN® ENDOPROSTHESIS PROSTHESIS, TRACHEAL, EXPANDABLE JCT W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention