BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE PROPATEN VASCULAR GRAFT

    MDR report key: 1972233 · Received January 21, 2011

    Report

    Report Number
    2017233-2011-00037
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    November 1, 2010
    Report Date
    January 21, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    DSY
    PMA / PMN Number
    K062161
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2010, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WERE TWO DEVICES INVOLVED IN THIS EVENT. A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONCLUDED. THE REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE HISTOLOGICAL ANALYSIS STATED THAT THE HISTOLOGICAL RESPONSE APPEARS CONSISTENT WITH A SEROMA.

    Description of Event or Problem · 1

    A PATIENT WAS IMPLANTED WITH TWO GORE PROPATEN VASCULAR GRAFTS IN THE ABDOMEN. IT WAS REPORTED TO GORE THAT THE PATIENT EXPERIENCED PERSISTENT SEROMA. AFTER GRAFT PLACEMENT, THE PATIENT HAD TO CONTINUALLY RETURN TO HAVE THE FLUID DRAINED. IT WAS REPORTED TO BE UP TO 300CC'S PER WEEK. ON (B)(6) 2010, THE GRAFT WAS EXPLANTED AND REPLACED WITH A DACRON GRAFT AND WAS RETURNED TO GORE FOR EVALUATION. IT IS UNKNOWN WHICH GRAFT WAS INVOLVED IN THE EVENT.

    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,INC WLG450 3174616PP027

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention GORE PROPATEN VASCULAR GRAFT (LOT # 3199732PP001)