BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 12075315 · Received June 28, 2021

    Report

    Report Number
    3004742232-2021-00234
    Event Type
    Death
    Date Received
    June 28, 2021
    Date of Event
    June 2, 2021
    Report Date
    June 28, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10850000491356
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 REQUESTED THE PHYSICIAN'S OPINION AS TO WHETHER ATHERECTOMY CONTRIBUTED TO THE EVENT. HOWEVER, THE PHYSICIAN COULD NOT FORM AN OPINION AS TO WHETHER CSI COULD BE RULED OUT AS CONTRIBUTORY. 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. CSI ID: (B)(4).

    Description of Event or Problem · 1

    A PATIENT WHO HAD BEEN UNSUCCESSFULLY TREATED WITH ANGIOPLASTY ON (B)(6) 2021 WAS BROUGHT TO THE CATH LAB FOR ATHERECTOMY WITH A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE ON (B)(6) 2021. THE SEVERELY CALCIFIED TARGET LESION WAS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD), WHICH WAS HIGHLY STENOSED. ATHERECTOMY WAS PERFORMED, AND CATH LAB STAFF DID NOT NOTICE ANY INDICATION OF VESSEL DAMAGE. A GUIDE CATHETER WAS PLACED, AND ANGIOPLASTY WAS PERFORMED. IMAGING THEREAFTER DEMONSTRATED A PERFORATION. THE PATIENT CODED, AND LIFE-SAVING MEASURES WERE UNDERTAKEN. THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    972530 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 373253-1 10850000491356

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death