BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11581540 · Received March 29, 2021

    Report

    Report Number
    3004742232-2021-00098
    Event Type
    Injury
    Date Received
    March 29, 2021
    Date of Event
    May 25, 2020
    Report Date
    March 29, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. CSI CONTACTED THE CORRESPONDING AUTHOR OF THE ARTICLE, WHO STATED THAT THE INFORMATION REQUESTED BY CSI (CAUSES OF THE EVENTS, ATTRIBUTABILITY TO CSI DEVICE, LOT NUMBERS, ETC.) WAS NOT AVAILABLE. 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. BARRETT C, WARSAVAGE T, KOVACH C, MCGUINN E, PLOMONDON ME, ARMSTRONG EJ, WALDO SW. COMPARISON OF ROTATIONAL AND ORBITAL ATHERECTOMY FOR THE TREATMENT OF CALCIFIC CORONARY LESIONS: INSIGHTS FROM THE VA CLINICAL ASSESSMENT REPORTING AND TRACKING (CART) PROGRAM. CATHETER CARDIOVASC INTERV. 2021 FEB 1;97(2):E219-E226. DOI: 10.1002/CCD.28971. EPUB 2020 MAY 25. PMID: 32449836. (B)(4).

    Description of Event or Problem · 1

    BARRETT ET AL., 2020 - A LITERATURE ARTICLE WAS PUBLISHED AND INDICATED THAT THREE MYOCARDIAL INFARCTIONS, 16 PERFORATIONS, 13 NO REFLOW EVENTS, 25 DISSECTIONS AND THREE ACUTE CLOSURE EVENTS OCCURRED. BALLOON TAMPONADE, STENTING, AND MEDICAL TREATMENT WAS LIKELY ADMINISTERED TO RESOLVE SOME OF THE EVENTS. PER THE PHYSICIAN, IT IS UNKNOWN IF THE NO REFLOW, DISSECTIONS, ACUTE CLOSURE AND MYOCARDIAL INFARCTION EVENTS WERE RELATED TO THE CSI DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479192 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other