BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFESTENT VALEO VASCULAR STENT

    MDR report key: 1081036 · Received July 18, 2008

    Report

    Report Number
    9681442-2008-00104
    Event Type
    Malfunction
    Date Received
    July 18, 2008
    Date of Event
    June 16, 2008
    Report Date
    June 19, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTE
    Product Code
    FGE
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS BEING REPORTED BECAUSE THIS DEVICE IS THE SAME OR SIMILAR TO A DEVICE BEING USED IN THE UNITED STATES. THE EVENT IS CURRENTLY UNDER INVESTIGATION. ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANTATION PROCEDURE (INTRA-ARTERIAL), THE STENT WAS REMOVED FROM THE DELIVERY SYSTEM AND GOT 'LOST'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTENT VALEO VASCULAR STENT FGE ANGIOMED GMBH & CO. MEDIZINTE 58316985

    Patients

    Seq Age Sex Outcome Treatment
    1