BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 10498438 · Received September 6, 2020

    Report

    Report Number
    2017233-2020-01238
    Event Type
    Injury
    Date Received
    September 6, 2020
    Date of Event
    January 1, 2020
    Report Date
    September 7, 2020
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)-THE ITEM NUMBER AND LOT NUMBER OF THE DEVICE COULD NOT BE PROVIDED, SO NO MANUFACTURING EVALUATION COULD NOT BE PERFORMED. (B)(4)-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
    962666 GORE TAG THORACIC ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention