BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS 3F AORTIC BIOPROSTHESIS

    MDR report key: 1673919 · Received April 27, 2010

    Report

    Report Number
    2031780-2010-00007
    Event Type
    Other
    Date Received
    April 27, 2010
    Date of Event
    March 25, 2010
    Report Date
    March 29, 2010
    Manufacturer
    ATS MED, 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

    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 AORTIC BIOPROSTHESIS (INSIDE A BIOROOT) WAS EXPLANTED DUE TO STREP FECALIS ENDOCARDITIS AND A PROBABLE ROOT ABSCESS. BIOROOT WAS REMOVED AND REPLACED WITH AN AORTIC HOMOGRAFT. DOCTOR REPORTED THAT THE INFECTION HAS NOTHING TO DO WITH THE VALVE, IT IS AN UNFORTUNATE AND KNOWN RISK. PT IS REPORTEDLY DOING FINE. AT EXPLANT, THE DOCTOR REPORTED THAT THERE WAS A LARGE VEGETATION ON THE NON-CORONARY LEAFLET OF THE 3F BIOPROSTHESIS OPPOSITE THE SMALL AREA OF INFECTED ANNULUS AND DEHISCENCE. THE REMAINDER OF THE VALVE WAS NOT INVOLVED. THE GRAFT WAS FINE. THE PT IS DOING VERY WELL.

    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 72 YR Required Intervention