BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 2480214 · Received February 24, 2012

    Report

    Report Number
    3004742232-2012-00030
    Event Type
    Injury
    Date Received
    February 24, 2012
    Date of Event
    October 25, 2010
    Report Date
    October 25, 2010
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, AN ANALYSIS OF THE ACTUAL COMPLAINT DEVICE IS NOT POSSIBLE. THE DEVICE HISTORY RECORD FOR THIS DEVICE WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. THE ROOT CAUSE FOR THE REPORTED EVENT IS UNKNOWN. A RECENT ANALYSIS OF CSI'S POST MARKET CLINICAL STUDIES IDENTIFIED EVENTS THAT SHOULD HAVE PREVIOUSLY BEEN REPORTED TO FDA. THIS IS REPORT #28 OF 48 EVENTS IDENTIFIED DURING THIS REVIEW. THIS REPORT CONTAINS LIMITED INFORMATION REGARDING THE INTERVENTION AND ROOT CAUSE OF THE EVENT, BUT THIS EVENT IS NOT CONSIDERED UNUSUAL, UNIQUE OR UNCOMMON AND DOES NOT INVOLVE A DEVICE WHICH IS THE SUBJECT OF A REMEDIAL ACTION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CLINICAL REPORT FORM FROM THE (B)(4) STUDY THAT DURING AN ORBITAL ATHERECTOMY (OA) TREATMENT PROCEDURE, A VESSEL DISSECTION OCCURRED IN THE POPLITEAL (POP) ARTERY POST-ATHERECTOMY. THREE LESIONS WERE TREATED; TWO LESIONS WERE LOCATED IN THE SFA AND ONE LESION WAS LOCATED IN THE POP ARTERY. THE FIRST SFA LESION WAS 99% STENOTIC, MILDLY CALCIFIED, AND FOCAL IN LENGTH. THE SECOND SFA LESION WAS 80% STENOTIC, MILDLY CALCIFIED, AND 30MM IN LENGTH. THE POP LESION WAS 85% STENOTIC, MILDLY CALCIFIED, AND 20MM IN LENGTH. THREE PATENT RUN-OFF VESSELS WERE PRESENT PRIOR TO THERAPY. THE FOCAL SFA LESION WAS TREATED WITH A 2.25MM SOLID CROWN OAD WHICH WAS SPUN FOR ONE RUN AT LOW SPEED (10SEC), AT MEDIUM SPEED FOR ONE RUN (10SEC), AND AT HIGH SPEED FOR ONE RUN (5SEC) FOR A TOTAL RUN TIME OF 25SEC. THE RESIDUAL STENOSIS WAS 50%. THE SECOND SFA LESION WAS TREATED WITH A 2.25MM SOLID CROWN OAD WHICH WAS SPUN FOR ONE RUN AT LOW SPEED (10SEC), AT MEDIUM SPEED FOR ONE RUN (10SEC), AND AT HIGH SPEED FOR ONE RUN (10SEC) FOR A TOTAL RUN TIME OF 30SEC. THE RESIDUAL STENOSIS WAS 40%. THE POP LESION WAS TREATED WITH A 2.25MM SOLID CROWN OAD WHICH WAS SPUN FOR ONE RUN AT LOW SPEED (10SEC), AT MEDIUM SPEED FOR ONE RUN (10SEC), AND AT HIGH SPEED FOR ONE RUN (10SEC) FOR A TOTAL RUN TIME OF 30SEC. THE RESIDUAL STENOSIS WAS 40%. AT THIS POINT, THE POP DISSECTION WAS NOTED. THE FOCAL SFA LESION WAS TREATED WITH A 6.0X40MM BALLOON FOR ONE INFLATION AT 4ATMS FOR A TOTAL INFLATION TIME OF 1MIN. THE RESIDUAL STENOSIS WAS 10%. THE SECOND SFA LESION WAS TREATED WITH A 6.0X40MM BALLOON FOR ONE INFLATION AT 4ATMS FOR A TOTAL INFLATION TIME OF 1MIN. THE RESIDUAL STENOSIS WAS 15%. THE POP LESION WAS TREATED WITH A 6.0X40MM BALLOON FOR ONE INFLATION AT 4ATMS FOR A TOTAL INFLATION TIME OF 1MIN. THE RESIDUAL STENOSIS WAS 15%. A 6.0X60MM STENT WAS PLACED IN THE POP ARTERY TO SUCCESSFULLY TREAT THE DISSECTION. THE EXPECTATIONS FOR THE CASE WERE MET. NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention
    2