BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT SOLO

    MDR report key: 2961539 · Received February 6, 2013

    Report

    Report Number
    2961539
    Event Type
    Malfunction
    Date Received
    February 6, 2013
    Date of Event
    December 31, 2012
    Report Date
    February 6, 2013
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NJ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING ANGIOPLASTY AND STENT PLACEMENTS IN THE LEFT SUPERFICIAL FEMORAL ARTERY AND LEFT COMMON ILIAC ARTERY.THE STENT WAS DEPLOYED BUT WOULD NOT RELEASE FROM THE WIRE. EVENTUALLY THE DELIVERY SYSTEM WAS CUT OFF BECAUSE IT WAS FOUND TO BE FRACTURED. THE STENT WAS THEN REMOVED.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?ANGIOPLASTY AND STENT PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50437 LIFESTENT SOLO STENT, SUPERFICIAL FEMORAL ARTERY NIP BARD PERIPHERAL VASCULAR, INC. * ANWK1167

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR