BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 2850365 · Received November 16, 2012

    Report

    Report Number
    2017233-2012-00762
    Event Type
    Injury
    Date Received
    November 16, 2012
    Date of Event
    June 1, 2012
    Report Date
    October 25, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    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 ON (B)(6) 2012 (THE PUBLICATION DATE "JUNE 2012" NOTED IN THE CITED WORK). THE ROOT CAUSES OF THE STENT GRAFT MIGRATION, CHANGE IN MENTAL STATUS, AND RIGHT SIDE WEAKNESS ARE UNKNOWN. AN ATTEMPT TO ACQUIRE INFORMATION REQUIRED FOR THIS FORM WAS MADE BY GORE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE, OR WAS NOT APPLICABLE. JOHNSON, PAMELA T., JAMES H. BLACK, STEFAN L. ZIMMERMAN, AND ELLLIOT 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 TOMOGRAPH (CT), WHICH IS THE PRIMARY PRE-AND POSTOPERATIVE IMAGING TOOL. THIS ARTICLE DESCRIBES A (B)(6) WOMAN WITH DISTAL AORTIC ARCH AND PROXIMAL DESCENDING THORACIC ANEURYSM, WITH EVIDENCE OF A SACCULAR ANEURYSM AND SURROUNDING PENETRATING ULCER. TEVAR WAS PERFORMED AFTER LEFT SUBCLAVIAN-TO-CAROTID BYPASS TO ALLOW LEFT SUBCLAVIAN ARTERY COVERAGE. AFTER TEVAR, AXIAL IMAGE FROM IV CONTRAST-ENHANCED CT SHOWS THROMBOSIS OF THE ULCER. AFTER THE STENT PLACEMENT, THE PATIENT DEVELOPED AN ACUTE CHANGE IN MENTAL STATUS AND WEAKNESS OF THE RIGHT SIDE OF HER BODY. THE STENT GRAFT HAD MIGRATED TOWARD THE LEFT COMMON CAROTID ARTERY, NECESSITATING PLACEMENT OF A CAROTID STENT. NORMAL CIRCULATION WAS RECOVERED, AND SHE HAD NO RESIDUAL DEFECT THEREAFTER.

    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,INC

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R