BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 3131408 · Received May 7, 2013

    Report

    Report Number
    2017233-2013-00289
    Event Type
    Injury
    Date Received
    May 7, 2013
    Date of Event
    April 18, 2013
    Report Date
    May 1, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS REQUESTED. IMAGES WERE SENT TO GORE FOR ANALYSIS AND THE RESULT OF THE INVESTIGATION WILL BE PROVIDED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE IS BEING CONDUCTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE PT WAS IMPLANTED WITH A CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A TYPE B DISSECTION. IT WAS REPORTED THAT THE PT HAD A BOVINE ARCH. THE LEFT SUBCLAVIAN ARTERY WAS REVASCULARIZED. DURING THE DEPLOYMENT, THE DEVICE MOVED 1 TO 2 CM AND PARTIALLY COVERED THE BRACHIOCEPHALIC ARTERY, HOWEVER, THE ARTERY REMAINED PERFUSED. NO CLINICAL SEQUELA WAS NOTED. ON (B)(6) 2013, A COMPUTED TOMOGRAPHY SCAN REVEALED A RETROGRADE TYPE A DISSECTION. ON (B)(6) 2013, THE PT UNDERWENT A SURGICAL PROCEDURE TO TREAT THE TYPE A DISSECTION. THE PT TOLERATED THE PROCEDURE. FURTHER INFORMATION WAS REQUESTED. IMAGES WERE SENT TO GORE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200154 GORE TAG THORACIC ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 11181753

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R