BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM

    MDR report key: 2150265 · Received June 6, 2011

    Report

    Report Number
    9681442-2011-00029
    Event Type
    Malfunction
    Date Received
    June 6, 2011
    Date of Event
    May 10, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    PMA / PMN Number
    P070014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS BEEN PROVIDED. A REVIEW OF THE DEVICE HISTORY RECORDS IS CURRENTLY BEING PERFORMED. THE SAMPLE HAS BEEN RETURNED TO THE MFR FOR EVAL. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VASCULAR STENT WAS ADVANCED TO THE TREATMENT SITE IN THE MID-SFA, BUT COULD NOT PASS THROUGH THE LESION TO DEPLOY THE STENT. THERE WAS RESISTANCE DURING RETRACTION OF THE DELIVERY SYSTEM. MOST OF THE STENT DEPLOYED IN THE INTRODUCER SHEATH BUT APPROX 2CM OF THE STENT DEPLOYED IN THE VESSEL. REPORTEDLY, THE SAFETY CLIP WAS NEVER REMOVED. THE DELIVERY SYSTEM AND STENT WERE PULLED THROUGH THE SHEATH WITH NO DAMAGE TO THE VESSEL. A COMPETITOR'S STENT WAS IMPLANTED WITHOUT INCIDENT. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK ANUI0954

    Patients

    Seq Age Sex Outcome Treatment
    1