BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE EVERFLEX SELFEXPANDING NITINOL STENT

    MDR report key: 1707037 · Received May 25, 2010

    Report

    Report Number
    2183870-2010-00094
    Event Type
    Other
    Date Received
    May 25, 2010
    Date of Event
    April 26, 2010
    Report Date
    May 14, 2010
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED ON THE SFA. DURING A PROCEDURE STENTING THE TOTAL SFA, THREE PROTEGE STENTS WERE DEPLOYED SUCCESSFULLY. HOWEVER, THE FOURTH PROTEGE EVERFLEX STENT WAS NOT ABLE TO DEPLOY AND DID NOT UNSHEATH PROPERLY. UPON EVALUATION OF THE DEVICE, THE TIP FROM THE THIRD PROTEGE STENT DEPLOYED WAS FOUND STRUNG TOGETHER WITH THE TIP ON THE UNDEPLOYED PROTEGE EVERFLEX AT THE DISTAL END OF THE OUTER SHEATH OF THE UNDEPLOYED STENT. NO INJURY TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX SELFEXPANDING NITINOL STENT FGE EV3 INC. PRB35-06-100-120 8020972

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other