BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 7063418 · Received November 28, 2017

    Report

    Report Number
    3004742232-2017-00139
    Event Type
    Death
    Date Received
    November 28, 2017
    Date of Event
    November 8, 2017
    Report Date
    December 20, 2017
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10852528005169
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE FACILITY, THEREFORE AN ANALYSIS OF THE REPORTED DEVICE IS NOT POSSIBLE. THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ORBITAL ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A PERFORATION OCCURRED AND THE PATIENT EXPIRED. THE TARGET LESION WAS 90% STENOSED AND A VENTRICULAR ASSIST DEVICE WAS UTILIZED DURING THE PROCEDURE. THE INITIAL NON-CSI GUIDEWIRE WAS REPLACED WITH A CSI VIPERWIRE GUIDEWIRE AND THE LESION WAS TREATED WITH TWO PASSES OF THE OAD ON LOW SPEED. WHEN THE OAD WAS REMOVED, THE LESION WAS RE-WIRED AND THREE STENTS WERE PLACED. DYE WAS INJECTED AND A PERFORATION WAS NOTED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE PATIENT STATUS BEGAN TO DECLINE AND RESUSCITATION EFFORTS WERE PERFORMED, HOWEVER THE PATIENT EXPIRED.

    Description of Event or Problem · 1

    IN ADDITION TO THE PERFORATION AND PATIENT DEATH, IT WAS REPORTED THAT A VESSEL SPASM OCCURRED DISTAL TO THE REGION OF OAD TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    842656 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 198945 10852528005169

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Death