BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT VASCULAR STENT

    MDR report key: 2992986 · Received March 1, 2013

    Report

    Report Number
    9681442-2013-00018
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    December 7, 2012
    Report Date
    January 31, 2013
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    Product Code
    NIP
    PMA / PMN Number
    P070014
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER FOR THE DEVICE IS UNK. THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE STENT REMAINS IMPLANTED. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST 3 MONTHS DEPLOYMENT OF A VASCULAR STENT, THE STENT WAS REPORTED TO BE TWISTED AND PINCHED. A PTA BALLOON GAINED ACCESS INTO THE VASCULAR STENT AND PRE DILATED TO NOMINAL SIZE. ANOTHER STENT WAS DEPLOYED WITHIN THE VASCULAR STENT SUCCESSFULLY. THERE IS NO REPORTED PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89103 LIFESTENT VASCULAR STENT NIP ANGIOMED GMBH & CO. MEDIZINTECHNIK KG

    Patients

    Seq Age Sex Outcome Treatment
    1