BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTÉGÉ ®GPS¿ SELF EXPANDING NITINOL STENT

    MDR report key: 2090254 · Received May 16, 2011

    Report

    Report Number
    2183870-2011-00099
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    April 16, 2011
    Report Date
    April 19, 2011
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE MIDDLE PART OF THE STENT WAS RUPTURED WHEN THE STENT WAS DEPLOYED.ONE IMAGE OF THE DEPLOYED STENT WAS RECEIVED WITH THE RETURNED DEPLOYMENT SYSTEM. THE RESOLUTION OF THE IMAGE PROVIDED WAS NOT SUFFICIENT TO DETECT ANY STRUT FRACTURES (RUPTURES).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROTÉGÉ ®GPS¿ SELF EXPANDING NITINOL STENT CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. SERP65-12-40-120 9401223

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other EVERCROSS PTA BALLOON