BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS 3F AORTIC BIOPROSTHESIS

    MDR report key: 1673917 · Received April 27, 2010

    Report

    Report Number
    2031780-2010-00006
    Event Type
    Other
    Date Received
    April 27, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 1, 2010
    Manufacturer
    ATS MED, INC.
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VALVE IS BEING RETURNED TO CONTRACT PATHOLOGY LAB FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS VALVE CONFIRMED THAT IT MET ALL SPECS AND PASSED ALL INSPECTIONS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    REPORTEDLY, 3F VALVE WAS EXPLANTED AT IMPLANT DUE TO TRACE AORTIC INSUFFICIENCY. SURGEON DECIDED TO REPLACE THE VALVE WITH A MEDTRONIC FREESTYLE VALVE. NO PT PROBLEMS WERE REPORTED AS A RESULT OF THIS EVENT. PT IS REPORTEDLY DOING FINE. SALES REP WAS PRESENT FOR THE CASE AND REPORTED THAT THERE DID NOT APPEAR TO BE ANYTHING WRONG WITH THE VALVE. HE FELT THE DOCTOR WAS OVER REACTING TO THE TRACE AI. IT WAS THE DOCTOR'S FIRST 3F IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS 3F AORTIC BIOPROSTHESIS ATS 3F AORTIC BIOPROSTHESIS LWR ATS MED, INC. 1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention