BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 7128480 · Received December 19, 2017

    Report

    Report Number
    3004742232-2017-00163
    Event Type
    Death
    Date Received
    December 19, 2017
    Date of Event
    December 8, 2017
    Report Date
    December 19, 2017
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCX
    UDI-DI
    10852528005169
    PMA / PMN Number
    P130005
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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. (B)(4).

    Description of Event or Problem · 1

    DURING A CORONARY ATHERECTOMY PROCEDURE USING A CSI ORBITAL ATHERECTOMY DEVICE (OAD), A PERFORATION OCCURRED AND THE PATIENT EXPIRED. THE TARGET LESIONS WERE HEAVILY CALCIFIED AND LOCATED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND THE DIAGONAL BRANCH. THE FIRST LESION WAS TREATED WITH THE OAD USING TWO PASSES ON LOW SPEED, AND THE SECOND LESION WAS TREATED USING ONE PASS ON LOW SPEED. IMAGING WAS PERFORMED AND NO COMPLICATIONS WERE NOTED. A NON-CSI GUIDE WIRE WAS INSERTED INTO THE DIAGONAL BRANCH, AND THROMBUS FORMATION WAS NOTED IN THE LAD. THE PRESSURE OF THE PATIENT BEGAN TO DECREASE AND THE PATIENT ENTERED VENTRICULAR FIBRILLATION. DEFIBRILLATION WAS PERFORMED TO RETURN THE PATIENT TO SINUS RHYTHM, AND INTUBATION AND A VENTRICULAR ASSIST DEVICE WERE IMPLEMENTED. BALLOON ANGIOPLASTY AND STENT DEPLOYMENT WERE PERFORMED IN THE DIAGONAL BRANCH. WHEN A SECOND STENT WAS PLACED IN THE LAD, A PERFORATION WAS NOTED. MULTIPLE ATTEMPTS WERE MADE TO TAMPONADE AND PERFORM BALLOON ANGIOPLASTY IN THE AREA OF THE PERFORATION AND A STENT WAS DEPLOYED, HOWEVER THE BLEEDING WAS UNABLE TO BE CONTAINED. A COIL WAS PLACED BEHIND THE STENT, HOWEVER UPON REMOVAL OF THE CATHETER THE COIL EMBOLIZED AND THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910032 DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM CORONARY ATHERECTOMY DEVICE MCX CARDIOVASCULAR SYSTEMS, INC. DBEC-125 202216 10852528005169

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death