BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERFLEX¿ SELF EXPANDING PERIPHERAL STENT SYSTEM

    MDR report key: 2852997 · Received November 30, 2012

    Report

    Report Number
    2183870-2012-00225
    Event Type
    Injury
    Date Received
    November 30, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 1, 2012
    Manufacturer
    EV3 INC.
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE STENT WAS IMPLANTED ON (B)(6 )2012. IT WAS THEN REPORTED THAT THE STENT FRACTURED WITHIN A CALCIFIED VESSEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVERFLEX¿ SELF EXPANDING PERIPHERAL STENT SYSTEM CATHETER, BILIARY, DIAGNOSTIC FGE EV3 INC. PRB35-08-100-120 9609728

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 6F ANSEL SHEATH