BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT XL VASCULAR & BILIARY 7X100

    MDR report key: 1981174 · Received January 24, 2011

    Report

    Report Number
    MW5019281
    Event Type
    Injury
    Date Received
    January 24, 2011
    Date of Event
    January 13, 2011
    Report Date
    January 20, 2011
    Manufacturer
    BARD PERIPHERAL VASCULAR
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    LIFESTENT WAS DEPLOYED IN ILIAC ARTERY UNDER FLUOROSCOPIC VISUALIZATION. WHEN DEPLOYMENT DEVICE WAS PULLED, IT WAS NOT SEPARABLE FROM THE WIRE; THE STENT WAS ENTRAPPED INSIDE THE SHEATH. THE STENT HAD TO BE REMOVED BY SURGICAL ARTERIOTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT XL VASCULAR & BILIARY 7X100 ARTERIAL STENT FGE BARD PERIPHERAL VASCULAR EX071003CS ANUI2457

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention