BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMMETRY AORTIC CONNECTOR BYPASS SYSTEM

    MDR report key: 893126 · Received August 13, 2007

    Report

    Report Number
    2135392-2007-00003
    Event Type
    Injury
    Date Received
    August 13, 2007
    Date of Event
    August 20, 2001
    Report Date
    August 13, 2007
    Manufacturer
    ST. JUDE MEDICAL ATG, INC.
    Product Code
    NCA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A SIGNIFICANT HISTORY OF ISCHEMIC CAD AND PREVIOUS INTERVENTION IN 2001, (STENTING AND ANGIOPLASTY OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY AND DIAGONAL-D1, WITH IN-STENT RESTENOSIS OF THE ANGIOPLASTY SITE). APPROX THREE MONTHS LATER, THE PATIENT UNDERWENT OFF-PUMP CABG X3 WITH THE LEFT INTERNAL MAMMARY ARTERY (LIMA) TO LAD, AND A SJM SYMMETRY CONNECTOR WAS UTILIZED FOR A SAPHENOUS VEIN GRAFT (SVG) TO THE OBTUSE MARGINAL BRANCH (OMB). APPROX TWO MONTHS LATER,, THE PATIENT EXPERIENCED EARLY SVG FAILURE AND UNDERWENT COMPLEX INTERVENTION. THE SVG TO THE OMB WAS TOTALLY OCCLUDED AND WAS STENTED. THE PATIENT WAS IN STABLE CONDITION POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMMETRY AORTIC CONNECTOR BYPASS SYSTEM AORTIC CONNECTOR NCA ST. JUDE MEDICAL ATG, INC. ACN-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR