BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 2513622 · Received March 12, 2012

    Report

    Report Number
    9681442-2012-00029
    Event Type
    Malfunction
    Date Received
    March 12, 2012
    Date of Event
    February 9, 2012
    Report Date
    February 15, 2012
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE HAS NOT BEEN PROVIDED. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE STENT REMAINS IMPLANTED. THEREFORE, A DEVICE EVAL COULD NOT BE PERFORMED. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES PMA# P070014. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT FRACTURE WAS IDENTIFIED AFTER IMPLANTATION IN THE FEMORAL ARTERY AND ANGIOPLASTY WAS PERFORMED. THE STENT REMAINS IMPLANTED. NO PT INJURY WAS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1