BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 11300452 · Received February 9, 2021

    Report

    Report Number
    3004742232-2021-00035
    Event Type
    Death
    Date Received
    February 9, 2021
    Date of Event
    January 11, 2021
    Report Date
    February 9, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10850000491356
    PMA / PMN Number
    P130005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, 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 ID# (B)(4).

    Description of Event or Problem · 1

    A DIAMONDBACK CORONARY ORBITAL ATHERECTOMY DEVICE (OAD) WAS SELECTED FOR USE IN A CALCIFIED, 99% STENOSED LESION IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD). THE VESSEL WAS 3.5-4.0MM IN DIAMETER WITH MODERATE TORTUOSITY DISTAL TO THE LESION. THE OAD WAS PLACED AT THE DISTAL SIDE OF THE LESION USING GLIDEASSIST MODE. MULTIPLE TREATMENTS WERE PERFORMED ON LOW SPEED IN A DISTAL TO PROXIMAL DIRECTION. AFTER TREATMENT, IMAGING SHOWED NO FLOW IN THE LAD. NITROGLYCERIN AND ADENOSINE WERE ADMINISTERED AND LITTLE IMPROVEMENT WAS OBSERVED. BALLOON ANGIOPLASTY WAS PERFORMED, AND A PERFORATION WAS OBSERVED. ADDITIONAL BALLOON TAMPONADE WAS PERFORMED, A STENT WAS PLACED, AND EPINEPHRINE AND LEVOPHED WERE ADMINISTERED. NO COVERED STENT WAS AVAILABLE, AND THE PERFORATION WAS STILL PRESENT. A COVERED STENT WAS CALLED FOR FROM A SEPARATE FACILITY. THE PATIENT EXPERIENCED HYPOTENSION, CONTINUED TO DECOMPENSATE AND CODED MULTIPLE TIMES. A PULSE WAS RECOVERED. THE COVERED STENT ARRIVED AND WAS PLACED AT THE SITE OF THE PERFORATION. AN INTRA-AORTA BALLOON PUMP WAS PLACED, AND THE INTUBATED PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT. THE OPINION OF THE PHYSICIAN WAS THAT THE CSI DEVICE CAUSED THE PERFORATION, AND THAT THE PERFORATION WAS THE CAUSE OF THE NO FLOW. THE PATIENT EXPIRED ON (B)(6)2021. THE CAUSE OF DEATH WAS NOT AVAILABLE, HOWEVER, THE PATIENT'S DISCHARGE DIAGNOSES WERE LISTED AS SEVERE CORONARY ARTERY DISEASE, HYPOTENSION/HYPOVOLEMIC SHOCK, AND PULMONARY EDEMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197290 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 332139 10850000491356

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| R