BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 10354711 · Received August 3, 2020

    Report

    Report Number
    2017233-2020-01071
    Event Type
    Injury
    Date Received
    August 3, 2020
    Date of Event
    February 22, 2019
    Report Date
    August 3, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PFV
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE PERFORMED AS DEVICE ITEM/LOT NUMBERS WERE NOT AVAILABLE. THE IMAGES AND DEVICE WERE NOT AVAILABLE, THE IMAGING EVALUATION AND ENGINEERING EVALUATION COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION WAS REVIEWED: " ENDOVASCULAR AORTIC REPAIR IS A VIABLE STRATEGY FOR TREATMENT OF PRIMARY INFECTED ABDOMINAL AORTIC ANEURYSM¿ RECEIVED THROUGH ANN VASC SURG 2020; 63: 117¿128. THE AUTHORS: XIAO DI, CHANGWEI LIU, RONG ZENG, AND LENG NI. THE ARTICLE AIMED THAT INFECTED ABDOMINAL AORTIC ANEURYSM (IAAA) IS RARE, AND INFORMATION IS LIMITED WHETHER ENDOVASCULAR AORTIC REPAIR (EVAR) CAN BE CONSIDERED A PERMANENT TREATMENT OR IS A TEMPORARY FIX PRECEDING OPEN SURGERY. THIS RETROSPECTIVE STUDY REVIEWED THE SHORT- AND LONGTERM OUTCOMES OF OPEN SURGERY, EMERGENT EVAR, AND ELECTIVE EVAR IN THE TREATMENT OF PRIMARY IAAA. THE STUDY POPULATION COMPRISED 19 PATIENTS TREATED FOR IAAA AT PEKING UNION MEDICAL COLLEGE HOSPITAL BETWEEN JANUARY 2008 AND JANUARY 2017. THE PATIENT (PATIENT 5) HAD LEFT IA STENOSIS, LEFT FA OCCLUSION(IMPLANTED WITH FENESTRATED GORE 23-12-120, LEFT FA VIABAHN 11-100; RIGHT FA VIABAHN 10-100) AND UNDERWENT AN ILIAC ARTERY STENT PLACEMENT WITH FEMORAL ARTERY ENDARTERECTOMY, 2 WEEKS AFTER THE FIRST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    819863 GORE VIABAHN ENDOPROSTHESIS ENDOVASCULAR GRAFT, ARTERIOVENOUS DIALYSIS ACCESS CIRCUIT STENOSIS TREATMENT PFV W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention