BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 2112301 · Received May 23, 2011

    Report

    Report Number
    9681442-2011-00026
    Event Type
    Injury
    Date Received
    May 23, 2011
    Date of Event
    April 25, 2011
    Report Date
    April 25, 2011
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHIK
    Product Code
    NIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS ARE CURRENTLY BEING REVIEWED. THE DEVICE WAS DISCARDED BY THE USER FACILITY; THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY. THIS EVENT IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO PMA #P070014 MARKETED IN THE UNITED STATES. NOTE: THE BALLOON DETACHMENT WAS REPORTED IN MANUFACTURER REPORT# 2020394-2011-00108.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER SUCCESSFUL STENT DEPLOYMENT, A PTA BALLOON BECAME ENTANGLED IN THE STENT AND THE STENT ELONGATED DURING THE ATTEMPT TO REMOVE THE BALLOON. SUBSEQUENTLY, THE ATTEMPTED RETRACTION OF THE BALLOON CATHETER RESULTED IN A BALLOON CATHETER SHAFT BREAK AND DETACHMENT, LEAVING THE BALLOON SEGMENT WITHIN THE PT. THE BALLOON AND PART OF THE STENT WERE SURGICALLY REMOVED. THE PT IS REPORTED TO BE DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT VASCULAR STENT NIP NIP ANGIOMED GMBH & CO. MEDIZINTECHIK ANUI1522

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention