BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 2480216 · Received February 24, 2012

    Report

    Report Number
    3004742232-2012-00031
    Event Type
    Injury
    Date Received
    February 24, 2012
    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 #29 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 CONFIRM II PREDATOR POST-APPROVAL STUDY THAT DURING AN ORBITAL ATHERECTOMY (OA) TREATMENT PROCEDURE, A MACRO-EMBOLISM EVENT OCCURRED IN THE POPLITEAL (POP) ARTERY POST-ATHERECTOMY. THE LESION BEING TREATED EXTENDED FROM THE COMMON FEMORAL ARTERY (CFA) INTO THE SFA. IT WAS 85% STENOTIC, MILDLY CALCIFIED, AND 100MM IN LENGTH WITH A 2 PATENT RUN-OFF VESSELS PRIOR TO THERAPY. THE LESION WAS TREATED WITH A 1.5MM SOLID CROWN OAD WHICH WAS SPUN FOR ONE RUN AT LOW SPEED (49SEC), AT MEDIUM SPEED FOR ONE RUN (47SEC), AND AT HIGH SPEED FOR ONE RUN (53SEC) FOR A TOTAL RUN TIME OF 2MIN, 30 SEC. THE RESIDUAL STENOSIS WAS 30%. PER THE PHYSICIAN, CLOT WAS NOT APPRECIATED ON PRE-PROCEDURE ANGIO; CLOT WAS NOTED IN THE POP ARTERY AND WAS RESOLVED WITH AN ANGIOJET ASPIRATION CATHETER. THE LESION WAS THEN TREATED WITH A 6.0X80MM BALLOON FOR ONE INFLATION FOR A TOTAL INFLATION TIME OF 1MIN. THE RESIDUAL STENOSIS WAS 15%. NO STENTS WERE PLACED DURING THIS PROCEDURE. 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 84 YR Required Intervention