BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11570021 · Received March 25, 2021

    Report

    Report Number
    3004742232-2021-00088
    Event Type
    Death
    Date Received
    March 25, 2021
    Date of Event
    February 24, 2021
    Report Date
    March 29, 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 · 0

    CORRECTION TO INITIAL MDR: THE B4 SECTION FOR DATE OF THIS REPORT WAS ENTERED IN AS 03/26/2021, HOWEVER IT SHOULD HAVE BEEN ENTERED IN AS THE DATE SUBMITTED, 03/25/2021. THIS WAS DISCOVERED THE DAY AFTER ON 03/26/2021. (B)(4)

    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. 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. (B)(4).

    Description of Event or Problem · 1

    ORBITAL ATHERECTOMY TREATMENTS WERE ADMINISTERED TO THE OSTIAL LEFT ANTERIOR DESCENDING (LAD) ARTERY FOR FOUR TREATMENT PASSES ON LOW SPEED. THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS DIFFICULT TO REMOVE, AND UPON REMOVAL A PERFORATION WAS OBSERVED IN THE MID LAD. THE PATIENT'S BLOOD PRESSURE DECREASED, AND A CODE WAS CALLED. CARDIOPULMONARY RESUSCITATION WAS ADMINISTERED, AND AN IMPELLA DEVICE WAS PLACED. ATTEMPTS TO ACCESS THE LAD AGAIN WERE UNSUCCESSFUL. THE PATIENT'S PULSE WAS RESTORED, AND THE PATIENT WAS TRANSFERRED TO SURGERY. A CORONARY ARTERY BYPASS GRAFT WAS PERFORMED, AND THE PATIENT WAS PLACED ON CARDIOPULMONARY BYPASS. HOWEVER, THE PATIENT EXPIRED UPON REMOVAL FROM BYPASS. PER THE OPINION OF THE PHYSICIAN, THE CAUSE OF THE PATIENT'S DEATH WAS A COMBINATION OF THE PERFORATION AND THE PATIENT'S INABILITY TO TOLERATE REMOVAL FROM BYPASS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463898 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 343983-1 10850000491356

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death