BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK¿ PLAQUE EXCISION SYSTEM

    MDR report key: 2066922 · Received April 22, 2011

    Report

    Report Number
    2183870-2011-00074
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 2011
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    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 DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO REPORTED EVENT.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PART OF THE DEFINITIVE LE STUDY: DURING THE TREATMENT OF THE RIGHT LOWER EXTREMITY, THERE WAS A PERFORATION OF THE SFA, FOLLOWING ATHERECTOMY WITH THE LX-M TURBOHAWK. THE PERFORATION WAS TREATED USING HEPARIN COATED, COVERED STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBOHAWK¿ PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. TH-LX-M 9382504

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention VIABAHN HEPARIN COATED COVERED STENT