BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 6912557 · Received October 3, 2017

    Report

    Report Number
    3004742232-2017-00099
    Event Type
    Death
    Date Received
    October 3, 2017
    Date of Event
    September 5, 2017
    Report Date
    October 3, 2017
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED BY THE FACILITY; THEREFORE, AN ANALYSIS OF THE ACTUAL COMPLAINT DEVICE IS NOT POSSIBLE. THE LOT NUMBER WAS NOT RECORDED AND COULD NOT BE OBTAINED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ORBITAL ATHERECTOMY PROCEDURE, THE PATIENT CODED AND REQUIRED ADDITIONAL INTERVENTION. THE TARGET LESION WAS TREATED WITH A CSI ORBITAL ATHERECTOMY DEVICE (OAD) AND THE PHYSICIAN FOLLOWED-UP WITH BALLOON ANGIOPLASTY. ANGIOGRAPHY DID NOT REVEAL ANY COMPLICATIONS AND THE PATIENT WAS STABLE. AT THAT POINT, A DRUG COATED STENT WAS ADVANCED INTO THE PATIENT AND DEPLOYED, BUT THE PATIENT CODED. A DISSECTION/CONTAINED PERFORATION WAS IDENTIFIED AND THE PHYSICIAN DEPLOYED A COVERED STENT ACROSS IT IN AN EFFORT TO RESOLVE. THE PATIENT STABILIZED AND WAS TRANSFERRED TO HOLDING. APPROXIMATELY ONE HOUR LATER, THE PATIENT CODED AND WAS BROUGHT BACK TO THE CATH LAB. A CLOT WAS OBSERVED WITHIN THE SECOND STENT, BUT THE PHYSICIAN REMOVED THE CLOT. THE PATIENT CODED A FEW MORE TIMES DURING THE INTERVENTION AND WAS ADMINISTERED PROTAMINE TO RESOLVE THE STENT CLOT. THE PATIENT WAS MONITORED IN THE FACILITY, BUT EXPIRED TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691570 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| L| R