BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACIST

    MDR report key: 1074606 · Received July 12, 2008

    Report

    Report Number
    2134243-2008-00004
    Event Type
    Death
    Date Received
    July 12, 2008
    Date of Event
    June 2, 2008
    Report Date
    July 11, 2008
    Manufacturer
    ACIST MEDICAL SYSTEMS
    Product Code
    DXT
    PMA / PMN Number
    K991103
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACIST CONTRAST INJECTION SYSTEM WAS TAKEN OUT OF SERVICE IN THE NEXT DAY OF EVENT, AND RETURNED TO ACIST FOR TESTING ABOUT ONE WEEK LATER. THE SYSTEM IS CURRENTLY UNDERGOING TESTING. THE DISPOSABLE KITS USED DURING THE PROCEDURE WERE DISCARDED BY THE HOSPITAL; THEREFORE, NO ANALYSIS CAN BE PERFORMED ON THESE ITEMS. ON 13-JUN-2008 A MEMBER OF ACIST'S MEDICAL ADVISORY BOARD SPOKE WITH THE PHYSICIAN AND DISCUSSED THE EVENT. DURING THIS DISCUSSION, IT WAS REPORTED THAT THE DISSECTION EVENT RESULTED IN THE PT'S DEATH. ALTHOUGH THIS EVENT IS NOT CONSIDERED DEVICE-RELATED, UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED TO FDA.

    Description of Event or Problem · 1

    NARRATIVE: USER FACILITY REPORTS: DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A CATHETER-INDUCED DISSECTION OF THE LEFT MAIN ARTERY EXTENDING TO THE AORTA WAS NOTICED UPON THE FIRST ANGIOGRAPHIC INJECTION. A STENT DEVICE WAS DEPLOYED AT THE LESION. CT SURGERY CONSULT WAS CALLED AT THE FIRST NOTICE OF THE DISSECTION. AN ASCENDING AORTIC ROOT INJECTION REVEALED A LARGE DISSECTION WITH PRESERVATION OF FLOW IN THE LEFT CORONARY ARTERY AND THE RIGHT CORONARY ARTERY FROM THE TRUE LUMEN. THE PT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE. IT WAS DECIDED TO TAKE THE PT TO URGENT SURGERY TO REPAIR THE DISSECTION, REPLACE THE AORTIC VALVE IF NECESSARY, AND PERFORM CORONARY ARTERY BYPASS SURGERY. IT WAS REPORTED TO ACIST ON 13-JUN-2008 THAT THE EVENT RESULTED IN PT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACIST ANGIOGRAPHIC INJECTION SYSTEM DXT ACIST MEDICAL SYSTEMS CMS2000 NI

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Death