BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK¿ PLAQUE EXCISION SYSTEM

    MDR report key: 2072650 · Received April 29, 2011

    Report

    Report Number
    2183870-2011-00081
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 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 MANUFACTURING RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PART OF THE DEFINITIVE LE STUDY: THE TURBOHAWK LS-C STANDARD TIP ATHERECTOMY DEVICE WAS USED. INITIALLY 4 PASSES AND THE DEVICE WAS REMOVED TO CLEAN. HOWEVER, THE PLAQUE COULD NOT BE REMOVED FROM THE NOSECONE THEREFORE, AND A SECOND TURBOHAWK LS-C WAS THEN USED TO PERFORM AN ADDITIONAL SEVEN PASSES THROUGH THE LESION. ANGIOGRAPHY WAS THEN PERFORMED SHOWING A LINEAR DISSECTION, CAUSING 30-50% RESIDUAL STENOSIS WITH SOME RESIDUAL DYE SEEN IN THE WALL OF THE VESSEL UPON CLEARING OF THE OTHER VOLUME OF ANGIOGRAPHIC DYE DOWNSTREAM. INTRAVASCULAR ULTRASOUND WAS USED TO ANALYZE THE DISSECTION. AT THE SITE OF THE DISSECTION, THERE APPEARED TO BE A MINIMAL LUMINAL DIAMETER. IN ADDITION, THERE WAS EVIDENCE FOR A MOBILE LINEAR DISSECTION IMPINGING ON THE LUMEN OF THE VESSEL. THIS WAS FELT TO REPRESENT A SUBOPTIMAL RESULT SO THEY IMMEDIATELY USED BALLOON ANGIOPLASTY AND STENT IMPLANTATION. FINAL ANGIOGRAPHY WAS PERFORMED SHOWING A SMOOTH 0% RESIDUAL STENOSIS THROUGHOUT THE STENTED SEGMENT OF THE LEFT SUPERFICIAL FEMORAL ARTERY WITH A STEP-UP AND STEP-DOWN ACROSS THE STENT, NO EVIDENCE FOR DISSECTION. PLEASE REFERENCE MDR 2183870-2011-00080 FOR THE OTHER TURBOHAWK LS-C USED IN THE PROCEDURE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention TURBOHAWK THS-LS-C