BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMMETRY BYPASS SYSTEM

    MDR report key: 491309 · Received October 23, 2003

    Report

    Report Number
    2135392-2003-00137
    Event Type
    Injury
    Date Received
    October 23, 2003
    Date of Event
    May 29, 2003
    Report Date
    October 15, 2003
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    FZP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH UNSTABLE ANGINA PECTORIS AND OPCAB X5 WAS PERFORMED WITH THE LITA-LAD, SVG-DIAGONAL, SVG-OMI, SVG-OM2, AND SVG-PDA. THE DIAGONAL, OM1 AND PDA WERE ANASTOMOSED WITH AORTIC CONNECTORS (ACN-4550 X2, ACN-5560 X 1). POSTOP, THE PATIENT'S RECOVERY WAS UNREMARKABLE AND WAS PRESCRIBED 325 MG ASPIRIN DAILY WITHOUT PLAVIX. CARDIAC CATHETERIZATION 15 DAYS POSTOPERATIVELY DEMONSTRATED THE SVG-DIAGONAL WAS OCCLUDED, THE SVG-OMI WAS OCCLUDED PROXIMALLY, AHD THE SVG-RCA WAS OPEN BUT "DISEASED WITH GRUMOUS MATERIAL" IN THE PROXIMAL TWO-THIRDS, THE SVG-CIRCUMFLEX WAS PATENT, AND THE LITA-LAD WAS PATENT WITH A SMALL "KINK" THAT DID NOT APPEAR TO LIMIT FLOW AND HAD GOOD DISTAL FILLING. ANGIOPLASTY AND STENTS WERE PLACED IN THE DIAGONAL, OM1, OM2, AND RCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMMETRY BYPASS SYSTEM AORTIC CONNECTOR FZP ST. JUDE MEDICAL, INC. ACN-4550 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention