BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 2480211 · Received February 24, 2012

    Report

    Report Number
    3004742232-2012-00029
    Event Type
    Injury
    Date Received
    February 24, 2012
    Date of Event
    September 7, 2010
    Report Date
    September 7, 2010
    Manufacturer
    CARDIOVASCULAR SYSTEMS INC.
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Removal / Correction Number
    NA
    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 #27 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 CLASS C, FLOW-LIMITING DISSECTION EVENT OCCURRED POST ATHERECTOMY. TWO LESIONS WERE TREATED. THE SFA LESION WAS 100% STENOTIC, MILDLY CALCIFIED, AND 100MM IN LENGTH. THE POPLITEAL (POP) ARTERY LESION WAS 80% STENOTIC, MODERATELY CALCIFIED, AND 20MM IN LENGTH. TWO PATENT RUN-OFF VESSELS WERE PRESENT PRIOR TO THERAPY. THE SFA LESION WAS TREATED WITH A 2.0MM SOLID CROWN OAD WHICH WAS SPUN FOR ONE RUN AT LOW SPEED (33SEC), AT MEDIUM SPEED FOR ONE RUN (23 SEC), AND AT HIGH SPEED FOR ONE RUN (30SEC). THE RESIDUAL STENOSIS WAS 65%. THE POP LESION WAS TREATED WITH THE 2.0MM SOLID CROWN OAD WHICH WAS SPUN FOR ONE RUN AT LOW SPEED (15SEC), AT MEDIUM SPEED FOR ONE RUN (15SEC), AND AT HIGH SPEED FOR ONE RUN (17SEC). THE RESIDUAL STENOSIS WAS 50%. AT THIS TIME A POP ARTERY DISSECTION WAS NOTED. THE SFA LESION WAS TREATED WITH A 5.0X100MM BALLOON FOR ONE INFLATION AT 4ATMS AND WAS THEN UPSIZED TO A 6.0X100MM BALLOON FOR ONE INFLATION. THE RESIDUAL STENOSIS WAS >20%. THE POP LESION WAS TREATED WITH A 5.0X100MM BALLOON FOR ONE INFLATION AT 4ATMS AND WAS THEN UPSIZED TO A 6.0X100MM BALLOON FOR ONE INFLATION. THE RESIDUAL STENOSIS WAS >15%. A 7.0X60MM LIFE STENT WAS THEN PLACED IN THE POP ARTERY. 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 58 YR Required Intervention