BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 17139834 · Received June 15, 2023

    Report

    Report Number
    3004742232-2023-00162
    Event Type
    Injury
    Date Received
    June 15, 2023
    Date of Event
    May 1, 2023
    Report Date
    June 15, 2023
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT PROVIDED. IF THE LOT NUMBER IS PROVIDED, A DHR REVIEW WILL BE PERFORMED. THE DIAMONDBACK 360® CORONARY ORBITAL ATHERECTOMY SYSTEM INSTRUCTIONS FOR USE MANUAL STATES THAT VESSEL PERFORATION AND VASCULAR DISSECTION ARE POTENTIAL ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION WITH USE OF THE SYSTEM. CSI ID: (B)(4).

    Description of Event or Problem · 0

    A PRESENTATION REPORTED THAT DURING A PROCEDURE THAT INCLUDES ORBITAL ATHERECTOMY, 12 BLEEDING COMPLICATIONS, 3 DISSECTIONS, 5 PERFORATIONS, 5 CARDIOGENIC SHOCKS, 3 HEART FAILURES OCCURRED FROM JANUARY 2014 TO SEPTEMBER 2020. ORBITAL ATHERECTOMY FOR CALCIFIED OSTIAL CORONARY ARTERY DISEASE: A SINGLE-CENTER EXPERIENCE. AMER GHAZZAL, PRESENTER, SELIN SENDIL, AUTHOR, CHRISTIAN ALEJANDRO TORRES, MD, GARLY SAINT CROIX, MD, BRAD J. MARTINSEN, PHD, PRINCE SETHI, RALPH CIPRIANO, AJAY J KIRTANE, M.D., FSCAI, MARTIN B. LEON, M.D., NIRAT BEOHAR, MD. (2) MOUNT SINAI MIAMI MEDICAL CENTER, (2) MOUNT SINAI MEDICAL CENTER OF FLORIDA, CARDIOVASCULAR SYSTEMS, INC., KANSAS UNIVERSITY MEDICAL CENTER - KUMC, NEW YORK - PRESBYTERIAN COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, MOUNT SINAI MEDICAL CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838461 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other