BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS 3F AORTIC BIOPROSTHESIS

    MDR report key: 1669110 · Received April 16, 2010

    Report

    Report Number
    2031780-2010-00002
    Event Type
    Other
    Date Received
    April 16, 2010
    Date of Event
    February 22, 2010
    Report Date
    March 22, 2010
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION IN PROCESS. WILL FILE FOLLOW-UP REPORT ONCE ANALYSIS IS COMPLETE. VALVE HAS BEEN RETURNED TO CONTRACT PATHOLOGY LAB FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS VALVE CONFIRMED THAT IT MET ALL SPECIFICATIONS AND PASSED ALL INSPECTIONS PRIOR TO RELEASE.

    Description of Event or Problem · 1

    REPORTEDLY, 3F VALVE WAS EXPLANTED DUE TO AORTIC INSUFFICIENCY. FURTHER EXAMINATION REVEALED TWO AREAS OF PARAVALVULAR LEAKAGE. AT EXPLANT, THE DOCTOR FOUND THAT THE NATIVE TISSUE SURROUNDING THE VALVE WAS INFECTED, BUT THE 3F VALVE LOOKED FINE. VALVE WAS REPLACED WITH A MEDTRONIC 31MM VALVE CONDUIT. THE DOCTOR DOES NOT ATTRIBUTE THE INFECTION TO THE 3F VALVE. PATIENT IS REPORTEDLY DOING FINE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention