BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK LX-M PLAQUE EXCISION SYSTEM

    MDR report key: 1604675 · Received February 9, 2010

    Report

    Report Number
    2183870-2010-00018
    Event Type
    Injury
    Date Received
    February 9, 2010
    Date of Event
    November 19, 2009
    Report Date
    November 19, 2009
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THIS PROCEDURE WAS ATHERECTOMY OF IN-STENT RESTENOSIS: DURING FIRST PASS OF THE SILVER HAWK LX-M, THE DEVICE ENCOUNTERED THE MARKER BANDS ON THE PROXIMAL SIDE OF THE STENT. THE PHYSICIAN ASKED TECH TO TURN OFF DEVICE CATCHING THE STRUT IN THE CUTTER HEAD OPENING. THE PHYSICIAN ATTEMPTED VARIOUS TECHNIQUES TO TRY AND DISLODGE THE STRUT FROM THE STENT WITH NO RESOLUTION. THE PT DID GET THE DEVICE REMOVED WITH A 'SIMPLE' SURGERY AND DID FINE. NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK LX-M PLAQUE EXCISION SYSTEM MCW EV3 INC. P4055 7741860

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention