BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11465416 · Received March 11, 2021

    Report

    Report Number
    3004742232-2021-00075
    Event Type
    Injury
    Date Received
    March 11, 2021
    Date of Event
    April 16, 2019
    Report Date
    March 11, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CSI CONTACTED MEDIKIT (DISTRIBUTOR) IN THE GEOGRAPHY WHERE THESE EVENTS OCCURRED IN ORDER TO ATTEMPT TO OBTAIN THE COMPLAINT DEVICES AND MORE INFORMATION ABOUT THE EVENTS REPORTED. THE DISTRIBUTOR STATED, "KYOTO KATSURA HOSPITAL IS NOT ABLE TO DISCLOSE THOSE INFORMATION ON THE CLINICAL STUDY THAT IS CONFIDENTIAL MATTERS." 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. KOIKE, J., FUNATSU, A., KOBAYASHI, T., & NAKAMURA, S. (2019, APRIL 23). CLINICAL EXPERIENCE OF PERCUTANEOUS CORONARY INTERVENTION FOR SEVERELY CALCIFIED CORONARY ARTERY LESION WITH DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM. JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY, 73(15), S25-S26. DOI:HTTPS://DOI.ORG/10.1016/J.JACC.2019.03.076 SEE MDR 3004742232-2021-00074 FOR REPORTS OF SI. CSI ID: (B)(4).

    Description of Event or Problem · 1

    KOIKE ET AL., 2019 - A LITERATURE ARTICLE WAS PUBLISHED 16 APRIL 2019 AND INDICATED THE FOLLOWING: "CORONARY PERFORATION OCCURRED IN 1% LESION AND PERSISTENT SLOW FLOW IN 2%. THERE WERE 1 CARDIAC DEATH (0.5%), 23 NONQ MI (8%) AND NO TLR AS IN HOSPITAL MACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358130 DIAMONDBACK CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death