BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2850978 · Received November 19, 2012

    Report

    Report Number
    2017233-2012-00764
    Event Type
    Injury
    Date Received
    November 19, 2012
    Date of Event
    June 1, 2012
    Report Date
    October 25, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS AN EVENT DATE IS NOT AVAILABLE, THE DATE OF EVENT WILL BE NOTED AS (B)(6) 2012 [PUBLICATION DATE ("JUN 2012") NOTED N THE CITED WORK]. THE ROOT CAUSE OF THE PROXIMAL TYPE I ENDOLEAK IS UNKNOWN. JOHNSON, PAMELA T., JAMES H. BLACK, STEFAN L. ZIMMERMAN, AND ELLIOT K. FISHMAN. "THORACIC ENDOVASCULAR AORTIC REPAIR: LITERATURE REVIEW WITH EMPHASIS ON THE ROLE OF MULTIDETECTOR COMPUTED TOMOGRAPHY." SEMIN ULTRASOUND CT MR. 2012 JUN; 33(3): 247-64. DOI: 10.1053/J.SULT.2012.01.004.

    Description of Event or Problem · 1

    AN ARTICLE IN THE SEMINARS IN ULTRASOUND CT AND MRI PRESENTED A REVIEW OF THE CURRENT LITERATURE PERTAINING TO THORACIC ENDOVASCULAR AORTIC REPAIR (TEVAR), WITH EMPHASIS ON THE ROLE OF INTRAVENOUS CONTRAST-ENHANCED MULTI-DETECTOR COMPUTED TOMOGRAPHY (CT), WHICH IS THE PRIMARY PRE- AND POSTOPERATIVE IMAGING TOOL. THIS ARTICLE DESCRIBES A (B)(6) MAN WITH CHEST PAIN DUE TO A TYPE B DISSECTION, REPAIRED BY TEVAR AT OUTSIDE INSTITUTION. PERSISTENT SEVERE PAIN PROMPTED POSTOPERATIVE IMAGING. AN IV CONTRAST-ENHANCED CT REVEALED A TYPE I ENDOLEAK FROM THE PROXIMAL GRAFT, WHICH ENLARGED ON REPEAT CT 4 DAYS LATER, CAUSING REPERFUSION OF THE FALSE-LUMEN. DEFINITIVE SURGICAL REPAIR WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R