BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIATORR TIPS ENDOPROSTHESIS

    MDR report key: 1052406 · Received April 21, 2008

    Report

    Report Number
    2017233-2008-00278
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    April 23, 2008
    Report Date
    May 21, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIR
    PMA / PMN Number
    P040027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    DURING A TIPS PROCEDURE, THE GORE TIPS ENDOPROSTHESIS WAS MISTAKENLY DEPLOYED IN THE IVC, WHICH RESULTED IN THE DEVICE BEING IN THE RIGHT ATRIUM. THE DEVICE WAS RETRIEVED USING A GOOSENECK CATHETER VIA FEMORAL ARTERY ACCESS. AFTER DEVICE REMOVAL, THE PROCEDURE WAS DISCONTINUED WITH PLANS TO PERFORM THE PROCEDURE AT A LATER DATE. THE PHYSICIAN WAS REPORTED TO BE AN INEXPERIENCED TIPS USER, WHICH WAS NOT ALLOWED TO PERFORM DEVICE INSERTION WITHOUT THE PRESENCE OF AN EXPERIENCED COLLEAGUE. THE PHYSICIAN BELIEVED THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE VIATORR TIPS ENDOPROSTHESIS NONE MIR W. L. GORE & ASSOCIATES, INC. WLG315 05145644

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention