BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE HEMOBAHN® ENDOPROSTHESIS

    MDR report key: 4953502 · Received July 30, 2015

    Report

    Report Number
    2017233-2015-00478
    Event Type
    Injury
    Date Received
    July 30, 2015
    Report Date
    July 30, 2015
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    THE GORE® HEMOBAHN® ENDOPROSTHESIS WAS NEVER APPROVED FOR DISTRIBUTION IN THE US. THEREFORE, THIS EVENT IS NOT REPORTABLE. THIS SUPPLEMENTAL SERVES AS A RETRACTION OF MEWDATCH 2017233-2015-00478.

    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. THE ARTICLE REPORTED THAT OVER A SIX YEAR PERIOD, ENDING IN 2012, THE GORE HEMOBAHN® ENDOPROSTHESIS WAS IMPLANTED IN 1 CASE FOR ENDOVASCULAR REPAIR OF POPLITEAL ARTERY ANEURYSMS. IT WAS REPORTED THE PATIENT SHOWED THROMBOSIS OF THE HEMOBAHN AND ISCHEMIA OF MODERATE TO SEVERE INTENSITY ON DAY 30 POSTOPERATIVELY, UNDERGOING A SUCCESSFUL FEMOROPOPLITEAL BRIDGE WITH A POLYTETRAFLUOROETHYLENE PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497119 GORE HEMOBAHN® ENDOPROSTHESIS NIP W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention