BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 2050543 · Received March 15, 2011

    Report

    Report Number
    9681442-2011-00007
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Report Date
    February 17, 2011
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    PMA / PMN Number
    P070014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE IS UNK. THE DEVICE REMAINS IMPLANTED. THE INVESTIGATION IS UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT RESTENOSIS WITHIN THE STENT, IMAGING DEMONSTRATED A STENT FRACTURE. THE IN-STENT RESTENOSIS WAS RESOLVED WITH ANGIOPLASTY, BUT THE FRACTURE WAS LEFT UNRESOLVED WITH NO PLANS TO INTERVENE. THE PROCEDURE ENDED WITH GOOD FLOW THROUGH 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1