BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTEGE STENT

    MDR report key: 602506 · Received May 12, 2005

    Report

    Report Number
    2134479-2005-00009
    Event Type
    Injury
    Date Received
    May 12, 2005
    Date of Event
    April 8, 2005
    Report Date
    May 12, 2005
    Manufacturer
    EV3 INC
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    WHILE TRYING TO DEPLOY THE STENT, THE PHYSICIAN WAS UNABLE TO UNSHEATH THE PROXIMAL ONE THIRD OF THE STENT. ATTEMPTED TO PULL BACK ENTIRE ASSEMBLY AND STENT CAME THROUGH PUNCTURE SITE. THE PHYSICIAN PERFORMED A SURGICAL CUT DOWN OF THE COMMON FEMORAL ARTERY TO REMOVE PROXIMAL END THE PROTRUDING STENT. THE DEVICE ASSEMBLY WAS THROWN AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE STENT SELF-EXPANDING NITINOL STENT FGE EV3 INC SE7-7-150-120 566323

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention