BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTEGE STENT

    MDR report key: 655115 · Received December 15, 2005

    Report

    Report Number
    2134479-2005-00033
    Event Type
    Malfunction
    Date Received
    December 15, 2005
    Date of Event
    November 15, 2005
    Report Date
    November 17, 2005
    Manufacturer
    EV3 INC
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN POSITIONED THE STENT ACROSS THE SFA LESION. UPON DEPLOYMENT OF THE STENT HALF OF THE STENT DEPLOYED, THE OTHER HALF WOULD NOT DEPLOY. THE PHYSICIAN PULLED THE HALF DEPLOYED STENT INTO THE AORTA FEMORAL BIFURCATION GRAFT AND IT WOULD NOT COME ACROSS THE BIFURCATION. ADDITIONALLY, THE STENT DEPLOYED IN THE BIFURCATION HALF ONE SIDE, HALF ON THE OTHER SIDE. THE PHYSICIAN USED A SNARE TO CAPTURE THE STENT AND PULLED IT INTO THE LEFT SIDE OF THE ILIAC, INTO THE BI-FEM GRAFT. THIS WAS A SUCCESSFUL COMPLETION. THE PHYSICIAN THEN FOLLOWED UP WITH ANOTHER PROTEGE STENT IN THE SFA. THIS WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTEGE STENT FGE FGE EV3 INC SERB65-07-120-120 978083

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention