BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V

    MDR report key: 2223122 · Received August 16, 2011

    Report

    Report Number
    2223122
    Event Type
    Death
    Date Received
    August 16, 2011
    Date of Event
    August 6, 2011
    Report Date
    August 16, 2011
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD DIAGNOSTIC CORONARY ANGIOGRAM, LEFT HEART CATH AND LEFT VENTRICULOGRAM WITH ANGIOPLASTY. DURING PLACEMENT OF OVERLAPPING XIENCE 2.75 X 18 MM DES STENT (DISTAL) AND XIENCE 3.5 X 28 MM DES (PROXIMAL), THE 3.5 X 28 MM STENT BALLOON SHEARED OFF THE DEPLOYED STENT AND LODGED IN THE LEFT MAINSTEM AND PROXIMAL LEFT CIRCUMFLEX ARTERY. NUMEROUS ATTEMPTS WERE MADE TO RETRIEVE THE DISLODGED BALLOON WITHOUT SUCCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V CARDIAC CATHETER NIQ ABBOTT VASCULAR XIENCE V 1021841

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death