BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ ®EVERFLEX¿ SELF EXPANDING NITINOL STENT

    MDR report key: 2022892 · Received March 18, 2011

    Report

    Report Number
    2183870-2011-00043
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED ON THE LEFT ILIAC, VIA A RIGHT FEMORAL ACCESS SITE. THE PHYSICIAN PUT A SHEATH UP AND OVER THE BIFURCATION., PLANNING TO STENT THE LEFT INTERNAL ILIAC. THE PHYSICIAN FELT A LOT OF RESISTANCE GOING OVER BIFURCATION WITH THE PROTEGE EVERFLEX. ONCE STENT WAS DEPLOYED, THE PHYSICIAN BEGAN TO PULL BACK THE DEPLOYMENT SYSTEM. AT THAT TIME, THE DISTAL TIP OF CATHETER AND THE PROXIMAL MARKER BROKE OFF INSIDE PATIENT. THE PHYSICIAN ATTEMPTED TO SNARE THE CATHETER BUT WAS NOT SUCCESSFUL. AN IMMEDIATE CUT DOWN WAS PERFORMED TO REMOVE TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTÉGÉ ®EVERFLEX¿ SELF EXPANDING NITINOL STENT CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. PRB35-05-080-120 9062962

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 6F ANSEL SHEATH| GLIDEWIRE