BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2857971 · Received November 15, 2012

    Report

    Report Number
    2017233-2012-00768
    Event Type
    Injury
    Date Received
    November 15, 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 (THE PUBLICATION DATE ["JUN 2012"] NOTED IN THE CITED WORK). 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: 10.4053/J.SUIT 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 A DESCENDING THORACIC AORTIC DISSECTION REPAIRED BY TEVAR. AN MPR FROM IV CONTRAST-ENHANCED CT AFTER TEVAR IMAGES SHOW A STENT POSITIONED IN THE ARCH AND DESCENDING AORTA WITH NO COMPLICATIONS. RESIDUAL DISSECTION IS SEEN IN THE ABDOMINAL AORTA. THE PATIENT WAS NONCOMPLIANT WITH MEDICATION, AND THE PATIENT RETURNED 6 MONTHS LATER WITH RETROGRADE TYPE A DISSECTION AND ASCENDING THORACIC AORTIC PSEUDOANEURYSM, NECESSITATING SURGICAL REPAIR. CORONAL VOLUME RENDERING SHOWS A SURGICALLY REPAIRED ASCENDING AORTA.

    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 59 YR Hospitalization| R