BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 7028061 · Received November 14, 2017

    Report

    Report Number
    3004742232-2017-00130
    Event Type
    Death
    Date Received
    November 14, 2017
    Date of Event
    October 17, 2017
    Report Date
    December 21, 2017
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO CSI, THEREFORE AN ANALYSIS OF THE REPORTED DEVICE IS NOT POSSIBLE. THE LOT NUMBER WAS NOT RECORDED AND COULD NOT BE OBTAINED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY PROCEDURE UTILIZING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), THE PATIENT EXPIRED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE TARGET LESION WAS SEVERELY CALCIFIED AND LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE LESION WAS TREATED WITH THE OAD USING THREE PASSES ON LOW SPEED. WHEN STENTS WERE DEPLOYED AFTER TREATMENT WITH THE OAD, THE VESSEL BEGAN TO SHUT DOWN. BALLOON ANGIOPLASTY WAS PERFORMED AND VASODILATORS WERE ADMINISTERED, HOWEVER FLOW WAS UNABLE TO BE RESTORED AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807285 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Death