BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVERCROSS¿ PTA BALLOON

    MDR report key: 2072719 · Received April 29, 2011

    Report

    Report Number
    2183870-2011-00083
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    January 24, 2011
    Report Date
    March 31, 2011
    Manufacturer
    EV3 INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THERE WAS NO LOT NUMBER AVAILABLE.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PART OF THE (B)(6) STUDY: THE PATIENT PRESENTED WITH BILATERAL ILIAC DISEASE, THEREFORE, KISSING ANGIOPLASTY WAS PERFORMED. A PERFORATION WAS NOTED WITH THE EVERCROSS, WITH RECOIL AND SUBOPTIMAL PTA RESULTS REQUIRING KISSING STENTS. THE PERFORATION RESOLVED WITH THE DEPLOYMENT OF THE KISSING STENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EVERCROSS¿ PTA BALLOON CATHETER, PERCUTANEOUS DQY EV3 INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention