BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 2142892 · Received June 22, 2011

    Report

    Report Number
    2017233-2011-00301
    Event Type
    Injury
    Date Received
    June 22, 2011
    Date of Event
    May 24, 2011
    Report Date
    June 21, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REVIEW OF THE DEVICE MANUFACTURING RECORD HISTORY. INVESTIGATION IS CURRENTLY IN PROGRESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GRAFT SNAPPED APART AND WAS EXPLANTED. THE EVENT DID NOT HAPPEN AS A RESULT OF SUTURE TEAR. FURTHER INVESTIGATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE PROPATEN VASCULAR GRAFT DSY / PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER DSY W.L. GORE & ASSOCIATES WLG450 3150478PP019

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention