BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT FLEXSTAR XL VASCULAR STENT SYSTEM

    MDR report key: 1931610 · Received December 10, 2010

    Report

    Report Number
    9681442-2010-00115
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 19, 2010
    Report Date
    November 19, 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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS THE LOT NUMBER WAS UNKNOWN. THE STENT REMAINS IMPLANTED; THEREFORE, IT IS NOT AVAILABLE FOR EVALUATION. THE EVENT INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NINE MONTHS POST IMPLANT, A VASCULAR STENT PLACED IN THE DISTAL SFA/PROXIMAL POPLITEAL ARTERY, WAS OBSERVED TO BE TWISTED AND FRACTURED IN TWO PLACES. REPORTEDLY, THE PATIENT PRESENTED WITH CLAUDICATION AND ATTEMPTS WERE MADE TO RESOLVE THE STENT FRACTURE, BUT WERE UNSUCCESSFUL. A BYPASS PROCEDURE IS PLANNED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention