BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOVASCULAR SYSTEM, INC. (CSI) DIAMOND BACK CORONARY OAS

    MDR report key: 11607782 · Received April 1, 2021

    Report

    Report Number
    MW5100503
    Event Type
    Death
    Date Received
    April 1, 2021
    Date of Event
    March 2, 2021
    Report Date
    March 19, 2021
    Manufacturer
    CARDIOVASCULAR SYSTEM, INC. (CSI)
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PHYSICIAN PERFORMED AN ATHERECTOMY ON LEFT MAIN CORONARY ARTERY WITH 1.25 MM DIAMOND BACK CSI DEVICE. THE DEVICE SHEARED OFF THE TIP OF THE VIPERWIRE ADVANCE, AND IT REMAINED IN THE BODY. PERFORATION OCCURRED WITH RUPTURE OF THE PROXIMAL AND DISTAL RAMUS PARTIALLY TREATED WITH THE PLACEMENT OF A COVERED STENT. PERSISTENT EXTRAVASATION, THE DISTAL LEFT MAIN INTO THE CIRCUMFLEX HAD A COVERED STENT OBSTRUCTING FLOW INTO THE RAMUS. THE PATIENT REQUIRED AN INTRA-AORTIC BALLOON PUMP. THE INTRA-AORTIC BALLOON PUMP WAS REMOVED AND REPLACED WITH AN IMPELLA DEVICE. THE PATIENT WAS TRANSFERRED TO THE CRITICAL CARE UNIT. THE PATIENT'S CLINICAL CONDITION DETERIORATED, THE FAMILY AFTER DISCUSSION WITH THE PROVIDERS WITHDREW CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501244 CARDIOVASCULAR SYSTEM, INC. (CSI) DIAMOND BACK CORONARY OAS CATHETER, PERIPHERAL, ATHERECTOMY MCW CARDIOVASCULAR SYSTEM, INC. (CSI) DEBC-125 332139

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death