BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT VASCULAR

    MDR report key: 4643621 · Received March 27, 2015

    Report

    Report Number
    4643621
    Event Type
    Death
    Date Received
    March 27, 2015
    Date of Event
    March 13, 2015
    Report Date
    March 16, 2015
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    MGB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS IN CATH LAB FOR HEART CATH AND STENT PLACEMENTS, FOLLOWING THE END OF THE PROCEDURE, THE DR ATTEMPTED A PER-CLOSE DEVICE WHICH FAILED WITH TO EARLY DEPLOYMENT OF THE FOOT PLATES. A SECOND ONE WAS DEPLOYED AND WAS SUCCESSFUL. THERE WAS COPIOUS AMOUNTS OF BLOOD FLOW. PRESSURE WAS BEING HELD AND A SURGEON WAS CALLED IN. THE PT BEGAN HAVING ST ELEVATION AND WAS ACCESSED ON THE OTHER SIDE. PT ARRESTED AND CPR WAS STARTED, PT DIED ON THE CATH LAB TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204771 ABBOTT VASCULAR PRECLOSE MGB ABBOTT VASCULAR 0 8717645 01308 9 40929K1

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death