BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCOR/EPIC MITRAL SUPRA SIZER SET

    MDR report key: 1032115 · Received April 18, 2008

    Report

    Report Number
    2126673-2008-00002
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 24, 2008
    Report Date
    April 18, 2008
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE SURGEON NOTICED A TEAR IN THE AORTA DURING SURGERY. THE TEAR WAS NOT PRESENT PRIOR TO SIZING BUT WAS PRESENT PRIOR TO IMPLANTING THE VALVE. THE TORN AORTA WAS REPAIRED, AND THE PT CAME OFF BYPASS WITHOUT CONSEQUENCES. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCOR/EPIC MITRAL SUPRA SIZER SET BIOCOR/EPIC SIZER SET DWS ST. JUDE MEDICAL, INC. B1000

    Patients

    Seq Age Sex Outcome Treatment
    1 NI Hospitalization