BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN® VASCULAR GRAFT

    MDR report key: 3912106 · Received July 3, 2014

    Report

    Report Number
    2017233-2014-00349
    Event Type
    Injury
    Date Received
    July 3, 2014
    Report Date
    July 11, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2014 A GORE® PROPATEN® VASCULAR GRAFT WAS IMPLANTED. ON (B)(6) 2014 IT WAS REPORTED TO GORE THAT THE DEVICE OCCLUDED TWICE, DATE UNKNOWN. ON AN UNKNOWN DATE, AN ADDITIONAL PROCEDURE WAS PERFORMED, THE DEVICE IS NOW PATENT AND THE PATIENT WILL BE TREATED WITH THE DIALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390243 GORE PROPATEN® VASCULAR GRAFT PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 4333451PP007

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention