BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT FLEXSTAR XL BILIARY STENT

    MDR report key: 1243786 · Received November 24, 2008

    Report

    Report Number
    9681442-2008-00183
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    November 11, 2008
    Report Date
    November 11, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    FGE
    PMA / PMN Number
    K060487
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE STENT REMAINS IMPLANTED, THEREFORE, NO SAMPLE EVALUATION COULD BE DONE. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BILARY STENT WAS IMPLANTED, IN THE PROXIMAL POPLITEAL TO DISTAL SFA, AND A 7X60 STENT WAS ALSO PLACED IN AN OVERLAPPING FASHION, PROXIMAL TO THE BILIARY STENT. THE REASON FOR THE STENT IMPLANT WAS REPORTED TO BE "SUBOPTIMAL PTA, HEAVILY CALCIFIED VESSEL." THE PROCEDURE TOOK PLACE 5 MONTHS AGO, AND THE BILIARY STENT WAS NOW ALLEGED TO BE FRACTURED. THE PATIENT PRESENTED AT THE EMERGENCY ROOM. CIRCULATION WAS AFFECTED FROM THE KNEE DOWN AND THE PATIENT HAD A COLD FOOT. THE PHYSICIAN USED PTA BALLOONS TO OPEN THE STENT AND PLACED ONE 7X150 STENT TO MEND THE FRACTURED AREA. THE PATIENT WAS HOSPITALIZED FOR ONE NIGHT. FLOW WAS RESTORED AND IT AS A SUCCESSFUL RECANNALIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT FLEXSTAR XL BILIARY STENT FGE ANGIOMED GMBH & CO. MEDIZINTECHNIK 58503367

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R