BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1983586 · Received February 2, 2011

    Report

    Report Number
    2017233-2011-00052
    Event Type
    Death
    Date Received
    February 2, 2011
    Date of Event
    January 22, 2011
    Report Date
    February 1, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PT UNDERWENT TREATMENT WITH A GORE TAG THORACIC ENDOPROSTHESIS FOR A TRAUMATIC AORTIC TRANSECTION JUST DISTAL TO THE LEFT SUBCLAVIAN ARTERY. THE PT DID WELL, BUT WAS LOST TO FOLLOW-UP AFTER (B)(6) 2009 (AS DESCRIBED BY THE PHYSICIAN). ON (B)(6) 2011, THE PT PRESENTED WITH ISCHEMIA AND LOSS OF SENSATION FROM THE MID-CHEST DOWN. THE AORTA WAS OCCLUDED DUE TO PROXIMAL STENT-GRAFT COLLAPSE, AND AN EXPLORATORY LAPAROTOMY SHOWED THE BOWELS WERE DEAD. THE PHYSICIAN DECIDED TO PROVIDE COMFORT MEASURES ONLY, AND THE PT EXPIRED THE SAME DAY. THE PHYSICIAN WAS UNCERTAIN WHAT CAUSED THE DEVICE COLLAPSE; THERE WAS NO AUTOPSY, AND THE STENT-GRAFT WAS LEFT IN THE PT. FURTHER INVESTIGATION IS BEING CONDUCTED.

    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 WLG426 05915959

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| H