BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 2022181 · Received March 11, 2011

    Report

    Report Number
    9681442-2011-00005
    Event Type
    Malfunction
    Date Received
    March 11, 2011
    Date of Event
    January 27, 2011
    Report Date
    February 14, 2011
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO ONE MARKETED IN THE UNITED STATES PMA # P070014. THE STENT REMAINS IMPLANTED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VASCULAR STENT WAS FRACTURED DURING POST-DILATION WITH A PTA BALLOON. A COMPETITOR'S STENT WAS IMPLANTED TO RELINE THE STENT. THERE WAS NO REPORT OF INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK ANUK0274

    Patients

    Seq Age Sex Outcome Treatment
    1