BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK¿ PLAQUE EXCISION SYSTEM

    MDR report key: 2153687 · Received July 7, 2011

    Report

    Report Number
    2183870-2011-00130
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    May 5, 2010
    Report Date
    June 8, 2011
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PART OF OUR DEFINITIVE LE STUDY: A COVERED PERFORATION OCCURRED DURING THE PROCEDURE. THE SUBJECT COMPLAINED 1 DAY AFTER THE RE-INTERVENTION OF PAIN IN THE TREATED AND RE-TREATED LIMB. A COVERED STENT WAS DEPLOYED WITH HEPARIN. THE SYMPTOMS RESOLVED AFTER THE COVERED STENT WAS DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBOHAWK¿ PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. TH-LX-C 7819003

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention VIABAHN COVERED STENT