BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11761801 · Received May 3, 2021

    Report

    Report Number
    3004742232-2021-00162
    Event Type
    Death
    Date Received
    May 3, 2021
    Date of Event
    February 11, 2021
    Report Date
    June 30, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 PRIOR TO DISTRIBUTION. CSI ID: (B)(4).

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE REPORTED DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. THE DEVICE HISTORY RECORD FOR THE REPORTED OAD WAS UNABLE TO BE REVIEWED, AS THE LOT NUMBER WAS NOT PROVIDED. (B)(4).

    Description of Event or Problem · 1

    FOLLOWING THE USE OF A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE ON HIGH SPEED IN A 2.5MM VESSEL WITH NODULAR CALCIUM, A TYPE C DISSECTION OCCURRED. A STENT WAS PLACED AND CARDIOPULMONARY RESUSCITATION WAS PERFORMED FOR ONE HOUR, HOWEVER THE PATIENT WAS UNABLE TO BE RESUSCITATED. THIS PATIENT HAD MANY CO-MORBIDITIES INCLUDING SEVERE AORTIC STENOSIS, MULTI VESSEL DISEASE, AN EJECTION FRACTION OF 35% AND VERY LITTLE HEMODYNAMIC RESERVE. PER THE OPINION OF THE PHYSICIAN, THIS IS WHAT LED TO THE ULTIMATE DEATH OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658071 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 311150

    Patients

    Seq Age Sex Outcome Treatment
    1 Death