BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT

    MDR report key: 8520174 · Received April 12, 2019

    Report

    Report Number
    8520174
    Event Type
    Death
    Date Received
    April 12, 2019
    Date of Event
    March 28, 2019
    Report Date
    April 11, 2019
    Manufacturer
    ABBOTT
    Product Code
    NKM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO THE OPERATING ROOM ON (B)(6) 2019 FOR A MITRACLIP INSERTION. THE CLIP WAS DEPLOYED. AS PER PROTOCOL THE LOCK WAS TESTED UNDER FLUOROSCOPY. THE LOCK FAILED, AND THE CLIP ARMS OPENED. MULTIPLE ATTEMPTS TO RECLOSE THE DEVICE WERE UNSUCCESSFUL. THE MITRACLIP WAS UNABLE TO SAFELY BE REMOVED FROM THE PT, THEREFORE THE DELIVERY SYSTEM WAS ANCHORED TO THE GROIN WITH A TEGADERM AND THE PT REQUIRED EMERGENT REDO STERNOTOMY FOR MITRAL VALVE SURGERY AND REMOVAL OF MITRACLIP. THE PT REQUIRED AN IABP AND ECMO AND WAS TRANSPORTED TO NURSE UNIT FOR POST OP CARE. HE SUBSEQUENTLY DEVELOPED BLEEDING, SHOCK, AKI AND LEFT LOWER EXTREMITY ISCHEMIA. WHEN IT WAS DETERMINED THERE WERE NO FURTHER EFFECTIVE TREATMENTS TO OFFER THE PT, SUPPORT WAS WITHDRAWN PER FAMILY WISHES AND THE PT EXPIRED ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305078 ABBOTT MITRAL VALVE CLIP NKM ABBOTT MITRACLIP XTR UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death