BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLAIR

    MDR report key: 4020860 · Received August 1, 2014

    Report

    Report Number
    MW5037727
    Event Type
    Injury
    Date Received
    August 1, 2014
    Date of Event
    July 15, 2014
    Report Date
    July 31, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS END STAGE RENAL DISEASE AND UNDERWENT FISTULOGRAM BECAUSE OF A LEFT UPPER ARM ARTERIOVENOUS GRAFT WITH SLOW FLOW AND ABNORMAL PHYSICAL EXAM (HYPERPULSATILE). THE FISTULOGRAM SHOWED A 90% AXILLARY VEIN STENOSIS. A 8MM BALLOON ANGIOPLASTY WAS PERFORMED WITH FULL EFFACEMENT OF THE BALLOON BUT THERE WAS SIGNIFICANT RECOIL. WE PLACED AN APPROPRIATE SHEATH IN DEPLOYED THE BARD FLAIR 8X70 STRAIGHT STENT GRAFT BUT THE STENT GRAFT JAMMED AND WOULD NOT DEPLOY. WITH INCREASING PRESSURE THE COVER ON THE STENT GRAFT TORE AND THE STENT PARTIALLY DEPLOYED. THE PARTIALLY DEPLOYED STENT/SHAFT/AND INTRODUCER WERE REMOVED TOGETHER AND WE DEPLOYED SUCCESSFULLY A DIFFERENT STENT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451651 FLAIR STENT GRAFT MIH BARD PERIPHERAL VASCULAR FAS08070 ANXK0651

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R