BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 1760408 · Received July 13, 2010

    Report

    Report Number
    2017233-2010-00329
    Event Type
    Injury
    Date Received
    July 13, 2010
    Report Date
    July 12, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B) (6)2010, A PT WAS IMPLANTED WITH A GORE PROPATEN VASCULAR GRAFT IN A FEM-POP BYPASS APPLICATION. AT AN UNK DATE, THE PT PRESENTED WITH A SWOLLEN LEG. ULTRAFILTRATION WAS OBSERVED ALONG THE ENTIRE LENGTH OF THE GRAFT. THE FLUID WAS DRAINED WITH A SYRINGE. AT AN UNK DATE, THE FLUID RETURNED AND THE GRAFT WAS EXPLANTED ON (B) (6)2010.

    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 3090959PP023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention