BEUDAMED
    FDA Adverse Event Other Summary report: N

    PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT

    MDR report key: 1932239 · Received December 8, 2010

    Report

    Report Number
    2183870-2010-00190
    Event Type
    Other
    Date Received
    December 8, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    EV3, INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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. THE PROTEGE EVERFLEX STENT DELIVERY CATHETER PASSED THROUGH THE LESION VIA A CONTRALATERAL APPROACH. AFTER CONFIRMING THE POSITION, THE STENT WAS DEPLOYED IN THE RIGHT SFA. AS THE STENT WAS BEING DEPLOYED, THE DELIVERY CATHETER BOUNCED BACK AND FORTH ABNORMALLY. ON ANGIOGRAPHY, THE STENT APPEARED TO BE BUNCHED UP IN THE MIDDLE AND FORESHORTENED. PHYSICIAN HAD DIFFICULTY PASSING BALLOONS AND DEVICES THROUGH THE STENT AFTER DEPLOYMENT. NO INJURY TO THE PT REPORTED. WE COULD NOT CONFIRM ANY SHORTENING OF THE DEPLOYED PROTEGE EVERFLEX STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE EVERFLEX SELF EXPANDING NITINOL STENT FGE EV3, INC. PRB35-07-150-120 9051362

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other