BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN ENDOPROSTHESIS

    MDR report key: 10565032 · Received September 22, 2020

    Report

    Report Number
    2017233-2020-01278
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    January 1, 2020
    Report Date
    September 22, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ITEM NUMBER AND LOT NUMBER OF THE DEVICE COULD NOT BE PROVIDED, SO NO MANUFACTURING EVALUATION COULD NOT BE PERFORMED. THE DEVICE REMAINS IMPLANTED. THEREFORE, DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    THE FOLLOWING PUBLICATION WAS REVIEWED: "OFF-THE-SHELF DEVICES FOR TREATMENT OF THORACIC AORTIC DISEASES: MIDTERM FOLLOW-UP OF TEVAR WITH CHIMNEYS OR PHYSICIAN-MADE FENESTRATIONS" RECEIVED THROUGH "JOURNAL OF ENDOVASCULAR THERAPY 2020, VOL. 27(1) 132¿142". THE AUTHORS: LEI ZHANG, MD, PHD, MENG-TAO WU, MD, PHD, GUANG-LANG ZHU, MD, ET AL. THE ARTICLE AIMED TO EVALUATE THE MIDTERM OUTCOMES OF THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR) USING CHIMNEY GRAFTS (CH-TEVAR) OR THORACIC STENT-GRAFTS WITH FENESTRATIONS MADE ON THE BACK TABLE (F-TEVAR) TO TREAT THORACIC AORTIC DISSECTION (TAD) AND THORACIC AORTIC ANEURYSM (TAA). A RETROSPECTIVE ANALYSIS WAS CONDUCTED OF 474 CONSECUTIVE PATIENTS (MEAN AGE 62.3±10.7 YEARS; 346 MEN) TREATED WITH EITHER F-TEVAR (N=110) OR CH-TEVAR (N=364) FOR 352 TADS (81 F-TEVAR AND 271 CH-TEVAR) OR 122 TAAS (29 F-TEVAR AND 93 CH-TEVAR) FROM 2008 TO 2016. TAG WAS USED IN CH-TEVAR(96/364), VIABAHN WAS USED IN F-TEVAR(29/75) AND IN CH-TEVAR(260/518). THE RESULTS STATED TYPE I ENDOLEAK WAS IDENTIFIED IN 40 (8.4%) PATIENTS (ONLY 1 F-TEVAR CASE): 18 TAD CASES AND 22 TAA CASES OF THE TOTAL 474 PATIENTS. THIRTY-SIX (7.6%) PATIENTS UNDERWENT REINTERVENTION FOR PROXIMAL TYPE I ENDOLEAK, WITH DIMINISHED FLOW IN 31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1031210 GORE VIABAHN ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention