BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 2480166 · Received February 24, 2012

    Report

    Report Number
    3004742232-2012-00007
    Event Type
    Injury
    Date Received
    February 24, 2012
    Date of Event
    March 25, 2010
    Report Date
    March 25, 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
    CT, 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 #5 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 SLOW FLOW EVENT OCCURRED POST-ATHERECTOMY. TWO OCCLUSIONS MADE UP DIFFUSE DISEASE EXTENDING 40CM IN LENGTH IN THE LEFT SFA. THE LESIONS BEING TREATED WERE 95% STENOTIC AND SEVERELY CALCIFIED. ONE PATENT RUN-OFF VESSEL WAS PRESENT PRIOR TO THERAPY. THE LESIONS WERE TREATED WITH A 2.0, 30 MICRON, SOLID CROWN OAD WHICH WAS SPUN AT HIGH SPEED, BUT THE SPECIFIC RPMS AND TOTAL RUN TIME ARE UNKNOWN. AFTER THE SFA WAS SANDED TO <50% RESIDUAL STENOSIS, EMBOLI WAS NOTED IN THE DORSALIS PEDIS ARTERY RESULTING IN SLOW FLOW TO THE TPT, AT AND DP ARTERIES. HEPARIN AND TPA WERE INFUSED IN AN EFFORT TO ELIMINATE THE EMBOLI, BUT WERE UNSUCCESSFUL; THEREFORE, THE PATIENT WILL UNDERGO EMBOLECTOMY AND ENDARTERECTOMY. 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 86 YR Required Intervention