BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11661062 · Received April 13, 2021

    Report

    Report Number
    3004742232-2021-00129
    Event Type
    Death
    Date Received
    April 13, 2021
    Report Date
    April 21, 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 · 0

    CORRECTED FIELD: B4. THE INITIAL MDR WAS SUBMITTED WITH AN INCORRECT DATE OF REPORT, THE DATE OF REPORT FOR THE INITIAL REPORT SHOULD HAVE BEEN 14-APR-2020. CSI ID: (B)(4).

    Additional Manufacturer Narrative · 1

    CSI CONTACTED (B)(4) (DISTRIBUTOR) IN THE GEOGRAPHY WHERE THESE EVENTS OCCURRED IN ORDER TO ATTEMPT TO OBTAIN THE COMPLAINT DEVICES AND EVENT INFORMATON, AND ADDITIONAL INFORMATION HAS NOT YET BEEN RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. YUTAKA TANAKA, SHOHEI YOKOTA, TAKAHIRO HAYASHI, HIROKAZU MIYASHITA, HIROAKI YOKOYAMA, KAZUKI TOBITA, KOKI SHISHIDO, SHINGO MIZUNO, FUTOSHI YAMANAKA, SAEKO TAKAHASHI, AND SHIGERU SAITO. PROCEDURAL AND CLINICAL OUTCOMES WITH THE DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM: A CLASSIC CROWN WITH GLIDEASSIST AND VIPERWIRE ADVANCE FLEXTIP J AM COLL CARDIOL. 2020 MAR, 75 (11_SUPPLEMENT_1) 1237. SERIOUS INJURY INFORMATION RECEIVED IN THIS LITERATURE ARTICLE IS REPORTED IN MDR 3004742232-2021-00130. CSI ID: (B)(4).

    Description of Event or Problem · 1

    TANAKA ET AL. 2020 - A LITERATURE ARTICLE WAS PUBLISHED 24 MARCH 2020 AND INDICATED THAT CARDIAC DEATHS WAS 2.1%. PER THE PHYSICIAN, THE CSI DEVICES AND WIRES DID NOT CAUSE THE MYOCARDIAL INFARCTION, TARGET VESSEL REVASCULARIZATION OR CARDIAC DEATHS BUT MAY HAVE CONTRIBUTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    558378 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125

    Patients

    Seq Age Sex Outcome Treatment
    1 Death