BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1736080 · Received June 22, 2010

    Report

    Report Number
    2953161-2010-00119
    Event Type
    Death
    Date Received
    June 22, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 21, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK IS BEING CONDUCTED. THE REVIEW OF THE MFG PAPERWORK HAS NOT BEEN COMPLETED. FURTHER INVESTIGATION IS BEING CONDUCTED. ADD'L GORE EXCLUDER DEVICE ASSOCIATED WITH THIS EVENT: (B) (4). GORE TAG DEVICE ASSOCIATED WITH THIS EVENT: (B) (4) (REFER TO MFR REPORT # 2017233-2010-00301).

    Description of Event or Problem · 1

    ON (B) (6) 2006, THE PATIENT WAS IMPLANTED WITH A GORE TAG THORACIC ENDOPROSTHESIS TO TREAT A 4.5 CM SACCULAR ANEURYSM OF THE DESCENDING THORACIC AORTA. CALCIFICATION WAS NOTED WITHIN THE AORTA AND ACCESS VESSELS. THE PATIENT TOLERATED THE PROCEDURE. ON (B) (6) 2010, THE PATIENT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES. THE PATIENT DID WELL DURING THE PROCEDURE BUT THERE WAS NO PULSE IN THE RIGHT LEG UPON CLOSING. AN ENDARECTOMY WAS PERFORMED ON THE RIGHT SIDE. NEITHER THE ILIAC ARTERY NOR THE AORTA WAS RUPTURED; HOWEVER, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNK. AN AUTOPSY WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMETN MIH W. L. GORE & ASSOCIATES WLG325 7513030

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death| H DILTIAZIM| THE PATIENT HAD A PACEMAKER.| XALATAN| MULTI-VITAMIN| COUMADIN| ZEBETA| PRAVACHOL| ULTRAM| ALPRAZOLAM| DIGITEK| MEDICATIONS INCLUDED:| FUROSEMIDE