BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS 3F AORTIC BIOPROSTHESIS

    MDR report key: 1669109 · Received April 16, 2010

    Report

    Report Number
    2031780-2010-00003
    Event Type
    Other
    Date Received
    April 16, 2010
    Date of Event
    March 4, 2010
    Report Date
    March 18, 2010
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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, THE 3F VALVE WAS IMPLANTED UNEVENTFULLY (SINGLE INTERRUPTED SUTURE). TABS HAD BEEN LOCATED IN THE RIGHT HEIGHT AND DISTANCE. AORTA WAS SLIGHTLY NARROWED AT THE SINO-TUBULAR JUNCTION (STJ). THE SURGEON WAS NOT SURE IF HE SHOULD HAVE TAKEN A 19MM VALVE BUT DECIDED TO TAKE A 21MM VALVE AS HE THOUGHT IT WOULD HAVE BEEN ONLY THE STJ THAT WAS TOO NARROW. AFTER CLOSING THE AORTOTOMY, DURING TEE ASSESSMENT, THE ANESTHESIOLOGIST DISCOVERED AN AORTIC INSUFFICIENCY OF 2ND DEGREE, BETWEEN THE RIGHT AND NON-CORONARY COMMISSURES OF THE VALVE. THE HEART WAS RE-OPENED AND THE VALVE WAS REPLACED WITH A MEDTRONIC FREESTYLE MODIFIED SUBCORONARY, 21MM. NO PATIENT PROBLEMS WERE REPORTED AS A RESULT OF THIS EVENT.

    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 78 YR Required Intervention