BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM

    MDR report key: 1861965 · Received October 5, 2010

    Report

    Report Number
    9681442-2010-00097
    Event Type
    Injury
    Date Received
    October 5, 2010
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    NIP
    PMA / PMN Number
    P070014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IMPLANTED AND THE DELIVERY SYSTEM WAS DISCARDED BY USER FACILITY. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TWISTED STENT AND A FRACTURE WERE IDENTIFIED. REPORTEDLY, THE PATIENT UNDERWENT IMPLANT OF A 6X170 STENT IN THE DISTAL SFA AND A 6X60 STENT IN THE PROXIMAL SFA. APPROXIMATELY, ONE MONTH POST STENT IMPLANT, THE PATIENT PRESENTED WITH A COLD LEG. IMAGING WAS PERFORMED AND THE 6X170MM STENT APPEARED TO BE TWISTED AND FRACTURED. THE PHYSICIAN ATTEMPTED TO ADVANCE A WIRE THROUGH THE STENT BUT WAS UNABLE. THE PATIENT HAD A FEM-POP BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK ANUH0099

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention