BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1911763 · Received November 23, 2010

    Report

    Report Number
    2017233-2010-00522
    Event Type
    Injury
    Date Received
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED.

    Description of Event or Problem · 1

    ARTICLES WILL BE PUBLISHED ON PTS WHO UNDERWENT TREATMENT OF TRAUMATIC AORTIC TRANSECTIONS AND ACUTE TYPE B DISSECTIONS WITH THE GORE TAG THORACIC ENDOPROSTHESIS. POST-OPERATIVELY, THESE PTS PRESENTED WITH DEVICE COMPRESSION. THE PT CAPTURED IN THIS EVENT WAS TREATED FOR A TRAUMATIC AORTIC TRANSECTION WITH A GORE TAG THORACIC ENDOPROSTHESIS ON (B)(6), 2006. IN (B)(6) OF 2009, F/U ANGIOGRAPHY SHOWED A HEALED AORTIC INJURY, BUT POOR APPOSITION OF THE ENDOGRAFT TO THE AORTIC ARCH. THE PT WAS REPORTEDLY ASYMPTOMATIC AT THIS TIME. IN (B)(6) OF 2009, F/U IMAGING SHOWED DEVICE COLLAPSE. IT WAS REPORTED THE PT PRESENTED WITH COMPLETE BILATERAL LOWER EXTREMITY MOTOR AND SENSORY LOSS AND BOWEL INCONTINENCE. ON (B)(6), 2009, AN INTERVENTION OCCURRED WHEREBY AN ADDITIONAL GORE TAG THORACIC ENDOPROSTHESIS WAS IMPLANTED FOR PROXIMAL EXTENSION. THIS PROCEDURE REPORTEDLY RESOLVED THE COLLAPSE WITH THE PREVIOUSLY IMPLANTED DEVICE, AND THE PT HAD A FULL NEUROLOGIC RECOVERY. HOWEVER, A LACK OF APPOSITION TO THE AORTIC WALL WAS IDENTIFIED WITH NEWLY IMPLANTED GORE TAG THORACIC ENDOPROSTHESIS. ON AN UNK DATE, A CONVERSION WAS PERFORMED WHEREBY THE TWO GORE TAG THORACIC ENDOPROSTHESES WERE EXPLANTED, AND THE DISTAL AORTIC ARCH AND PROXIMAL DESCENDING AORTA WERE REPLACED WITH AN INTERPOSITION TUBE. THE PT TOLERATED THE PROCEDURE. ADDITIONAL INFO HAS BEEN REQUESTED.

    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 WLG326 03969411

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R TG3110/(B)(4)