BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE TAG THORACIC ENDOPROSTHESIS

    MDR report key: 1910001 · Received November 23, 2010

    Report

    Report Number
    2017233-2010-00516
    Event Type
    Death
    Date Received
    November 23, 2010
    Date of Event
    December 22, 2008
    Report Date
    November 22, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P040043
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MFG AND STERILIZATION RECORDS HAS BEEN CONDUCTED. RESULTS: THE MFG AND STERILIZATION RECORDS REVIEW VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PT UNDERWENT TREATMENT FOR AN ANEURYSM IN THE DESCENDING THORACIC AORTA WITH GORE TAG THORACIC ENDOPROSTHESES. THERE WAS NO PRE-EXISTING INFECTION. ON (B)(6) 2008, THE PT PRESENTED WITH AN INFECTION AROUND THE STENT-GRAFTS. ON (B)(6) 2008, THE PT EXPIRED. THE PHYSICIAN ATTRIBUTED THE DEATH TO THE STENT-GRAFT INFECTION.

    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 05804053

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| H| L ASPIRIN| REMERON| ZETIA| PROZAC| (B)(4)| NAFCILLIN| CRESTOR