BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 3203706 · Received June 24, 2013

    Report

    Report Number
    2017233-2013-00390
    Event Type
    Injury
    Date Received
    June 24, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 23, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS FROM THE FOLLOWING LITERATURE ARTICLE: MONACA V, BATTAGLIA G, TURIANO S. SUBPOPLITEAL REVASCULARIZATION. CRITERIA ANALYSIS FOR THE USE OF E-PTFE (PROPATEN) AS FIRST CHOICE CONDUIT. THE ITALIAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY. 2013;20:1-2. NO LOT NUMBER INFORMATION WAS SUPPLIED; THEREFORE, NO REVIEW OF THE MANUFACTURING PAPERWORK COULD BE PERFORMED. THE DEVICE WAS NOT RETURNED; CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE. WITHOUT ADDITIONAL INFORMATION IT IS IMPOSSIBLE TO FURTHER INVESTIGATION THIS EVENT.

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE, IT WAS REPORTED TO GORE THAT THERE WERE FOUR PTS IN WHICH GRAFT OCCLUSION WITH THE GORE PROPATEN VASCULAR GRAFT WAS CAUSED BY A GRAFT INFECTION. THE GRAFTS WERE ALL EXPLANTED AND THE INFECTIONS WERE TREATED BY ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    284768 GORE PROPATEN VASCULAR GRAFT DSY / PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention