BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE HYBRID VASCULAR GRAFT

    MDR report key: 2844758 · Received November 1, 2012

    Report

    Report Number
    2017233-2012-00742
    Event Type
    Malfunction
    Date Received
    November 1, 2012
    Date of Event
    October 4, 2012
    Report Date
    October 4, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    DSY
    PMA / PMN Number
    K093934
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED WITH LEFT LOWER EXTREMITY HEAVILY CALCIFIED OCCLUSIVE DISEASE. A GORE HYBRID VASCULAR GRAFT WAS USED DURING A LEFT ILIAC TO FEMORAL ARTERY BYPASS PROCEDURE. WHEN THE PACKAGING WAS OPENED, THE NITINOL REINFORCED SECTION (NRS) DEPLOYMENT LINE APPEARED SLIGHTLY UNRAVELED. THE USER DECIDED TO USE THE GRAFT. THE NRS WAS POSITIONED IN THE TARGETED VESSEL USING THE OVER THE WIRE TECHNIQUE. DURING DEPLOYMENT OF THE NRS, THE NRS EXPANDED SLIGHTLY BUT WAS UNABLE TO COMPLETE DEPLOYMENT. THE NRS CAME OUT OF THE TARGETED VESSEL AND THE PHYSICIAN WAS NOT ABLE TO POSITION THE NRS BACK INTO THE VESSEL. ANOTHER HYBRID GRAFT WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THE PT DID NOT EXPERIENCE ANY ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE HYBRID VASCULAR GRAFT DSY/PROSTHESIS, VASCULAR GRAFT DSY W.L. GORE & ASSOCIATES 10534385

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR