BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 3203694 · Received June 24, 2013

    Report

    Report Number
    2017233-2013-00389
    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 INVESTIGATE THIS EVENT.

    Description of Event or Problem · 1

    IN A LITERATURE ARTICLE, IT WAS REPORTED TO GORE THAT THERE WERE SEVEN CASES OF EARLY GRAFT OCCLUSION WITH THE GORE PROPATEN VASCULAR GRAFT. IN SIX OF THE PTS, THE OCCLUSION WAS RESOLVED BY A SIMPLE EMBOLECTOMY AND IN THE OTHER BY EMBOLECTOMY AND COMMON FEMORAL ANGIOPLASTY WITH PATCH. RE-THROMBOSIS REQUIRED AMPUTATION IN FOUR PTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    285887 GORE PROPATEN VASCULAR GRAFT DSY / PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention