BEUDAMED
    FDA Adverse Event Death Summary report: N

    GORE VIATORR TIPS ENDOPROSTHESIS

    MDR report key: 1702429 · Received May 26, 2010

    Report

    Report Number
    2017233-2010-00251
    Event Type
    Death
    Date Received
    May 26, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 25, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES, INC
    Product Code
    MIR
    PMA / PMN Number
    P040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH UNK. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE PUBLISHING PHYSICIAN. TIPSITIS: INCIDENCE AND OUTCOME - A SINGLE CENTRE EXPERIENCE. NARENDRA KOCHAR, DHIRAJ TRIPATHI, NIKOLASS J. ARESTIS, HAMISH IRELAND, DORIS N. REDHEAD, PETER C. HAYES EUROPEAN JOURNAL OF GASTROENTEROLOGY & HEPATOLOGY 2010; 22:729-735.

    Description of Event or Problem · 1

    A RETROSPECTIVE, SINGLE CENTER STUDY WAS PUBLISHED TO DISCUSS THE INCIDENCE AND OUTCOME OF TIPS PTS WHO DEVELOPED POST-PROCEDURAL INFECTION (TIPSITIS). TWO OF THE PTS WHO DEVELOPED TIPSITIS WERE IMPLANTED WITH A GORE VIATORR TIPS ENDOPROSTHESIS. THE SECOND PT MENTIONED UNDERWENT A TIPS PROCEDURE AND IMPLANTATION OF A VIATORR ENDOPROSTHESIS DUE TO ALCOHOLIC LIVER DISEASE AND BLEEDING ESOPHAGEAL VARICES. THE PT DEVELOPED AN ESCHERICHIA COLI INFECTION 25 MONTHS POST-PROCEDURE AND LATER DIED. DEATH WAS ATTRIBUTED TO "PROBABLE TIPSITIS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIATORR TIPS ENDOPROSTHESIS MIR SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS MIR W.L. GORE & ASSOCIATES, INC WLG315 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Death