BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABBOTT VASCULAR SUPERA

    MDR report key: 5525716 · Received March 22, 2016

    Report

    Report Number
    MW5061248
    Event Type
    Malfunction
    Date Received
    March 22, 2016
    Date of Event
    March 21, 2016
    Report Date
    March 22, 2016
    Manufacturer
    ABBOTT
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    STENT PLACED IN THE RIGHT POPLITEAL ARTERY AND WHEN REMOVING THE SHEATH, THE TIP OF THE SHEATH DISLODGED AND SEPARATED FROM THE BODY OF THE SHEATH, RESULTING IN AN OPEN PROCEDURE TO REMOVE THE TIM FROM THE VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172255 ABBOTT VASCULAR SUPERA STENT NIP ABBOTT S55150120P6 5112361

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR