BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT FLEXSTAR VASCULAR STENT SYSTEM

    MDR report key: 2121404 · Received June 7, 2011

    Report

    Report Number
    9681442-2011-00033
    Event Type
    Injury
    Date Received
    June 7, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    PMA / PMN Number
    P070014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE IS UNKNOWN. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS DISCARDED BY THE USER FACILITY. THEREFORE, A SAMPLE EVALUATION COULD NOT BE PERFORMED. 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 PROXIMAL POPLITEAL SFA. UPON DEPLOYMENT, THE STENT ELONGATED AND FRACTURED. THE PATIENT WAS TAKEN TO THE OPERATING ROOM TO SURGICALLY REMOVE THE STENT AND PLACE A COMPETITOR'S STENT IN THE PROFUNDA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention