BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT VASCULAR STENT SYSTEM

    MDR report key: 2254045 · Received August 10, 2011

    Report

    Report Number
    9681442-2011-00045
    Event Type
    Malfunction
    Date Received
    August 10, 2011
    Date of Event
    May 26, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    FGE
    PMA / PMN Number
    P070014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE STENT REMAINS IMPLANTED. THE DELIVERY SYSTEM WAS DISCARDED BY THE USER FACILITY. THEREFORE, A SAMPLE EVAL COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER CROSSING A CALCIFIED STENOSIS WITH 80% OCCLUSION IN THE SUPERFICIAL FEMORAL ARTERY, THE PHYSICIAN ENCOUNTERED RESISTANCE DURING REMOVAL OF THE DELIVERY SYSTEM AND THE DISTAL TIP OF THE DELIVERY SYSTEM DETACHED. PENDING ADD'L INFO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT VASCULAR STENT SYSTEM FGE ANGIOMED GMBH & CO. MEDIZINTECHNIK KG ANVC1059

    Patients

    Seq Age Sex Outcome Treatment
    1