BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST JUDE MEDICAL

    MDR report key: 390877 · Received April 10, 2002

    Report

    Report Number
    390877
    Event Type
    Other
    Date Received
    April 10, 2002
    Date of Event
    February 27, 2002
    Report Date
    April 3, 2002
    Manufacturer
    ST JUDE MEDICAL
    Product Code
    FCP
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT RETURNED TO OR WITH COPIOUS BLEEDING INTO MEDIASTINUM POST-OP DAY #2 STATUS POST CAB6X4. BLEED NOTED AT RIGHT-SIDED (PDA) GRAFT PROXIMAL SITE AND SYMMETRY CONNECTOR (ACN 4550) APPEARED TO BE INTACT. IT WAS UNCLEAR WHETHER THE BLEEDING WAS DUE TO FRIABLE AORTA AT THIS SITE OR A DEFECT IN THE SAPHENOUS VEIN GRAFT ITSELF. REPAIR SUCCESSFUL. PT RECEIVED MULTI UNITS PACKED CELLS. POST-OP DAY #4 (2) WHILE ELEVATED BUN AND CREATINE AND POSSIBLE SEPTIC PICTURE, PT ARRESTED. AUTOPSY SHOWED AORTIC PATCH INTACT, POSSIBLE THROMBUS TO ALOM AND PDA GRAFTS, AND COMPLETE DEHISCENCE OF PROXIMAL ANASTOMOSIS OF PLOM GRAFT LIKELY DUE TO RESUSCITATION EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST JUDE MEDICAL SYMMETRY BYPASS SYSTEM (NITINOL AORTIC CONNECTOR) FCP ST JUDE MEDICAL ACN 4550 *

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other ACN (ACN 5560)| ST JUDE SYMMETRY CONNECTORS ALSO PLACED TO...| PLOM (ACN 5055)