BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11748819 · Received April 29, 2021

    Report

    Report Number
    3004742232-2021-00159
    Event Type
    Death
    Date Received
    April 29, 2021
    Date of Event
    April 5, 2021
    Report Date
    April 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 · 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. CSI: (B)(4).

    Description of Event or Problem · 1

    ORBITAL ATHERECTOMY (OA) WAS SELECTED FOR TREATMENT OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS OPERATED ON LOW SPEED FOR TWO TREATMENT PASSES, WITH ANGIOGRAMS PERFORMED BETWEEN EACH TREATMENT PASS. A SMALL ST ELEVATION WAS NOTED AFTER THE SECOND TREATMENT PASS AND RESOLVED WITHOUT INTERVENTION. DURING THE THIRD TREATMENT PASS IT SOUNDED AS IF THE OAD HAD SEIZED, AND THE PHYSICIAN NOTED A TACTILE CHANGE IN THE DEVICE. DURING THE REMOVAL PROCESS, THE GUIDE WIRE CAME BACK WITH THE OAD AND WIRE ACCESS WAS LOST. THE PATIENT WAS STABLE BUT BECAME HYPOTENSIVE AND A VESSEL PERFORATION WAS IDENTIFIED. THE PERFORATION SIZE INCREASED AND MOVED TOWARD THE PROXIMAL END OF THE VESSEL. THE PATIENT WAS INTUBATED, AND A NON-CSI WIRE WAS INSERTED TO PROTECT THE LEFT CIRCUMFLEX AS ATTEMPTS TO RECANNULATE THE LAD WERE MADE. AN IMPELLA DEVICE WAS PLACED TO ASSIST WITH HEART FUNCTION. THE PATIENT EXPERIENCED CARDIAC TAMPONADE AND SURGERY WAS CONSULTED TO PERFORM A PERICARDIAL WINDOW. THE PATIENT IMPROVED SLIGHTLY, BUT LAD FLOW WAS ABSENT. AN INFLATED BALLOON WAS LEFT IN THE LAD AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT WITH THE IMPELLA DEVICE AND SHEATHS IN PLACE FOR PALLIATIVE CARE. THE PATIENT EXPIRED THE FOLLOWING MORNING. PER THE PHYSICIAN, THE CAUSE OF DEATH WAS CARDIAC TAMPONADE CAUSED BY THE PERFORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645610 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 365615-1 10850000491356

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death