BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS 3F AORTIC BIOPROSTHESIS

    MDR report key: 1709352 · Received May 25, 2010

    Report

    Report Number
    2031780-2010-00010
    Event Type
    Other
    Date Received
    May 25, 2010
    Date of Event
    May 24, 2010
    Report Date
    May 24, 2010
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWR
    PMA / PMN Number
    P060025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VALVE DESTROYED AT TIME OF EXPLANT. NOTHING TO BE RETURNED TO ATS 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 AORTIC BIOPROSTHESIS WAS EXPLANTED AFTER 7 DAYS IMPLANT DURATION DUE TO SIGNIFICANT AORTIC INSUFFICIENCY AS SEEN ON TEE. THERE WAS A JET COMING THROUGH THE CENTER OF THE VALVE. DOCTOR THOUGHT THAT ONE OF THE TABS MAY HAVE COME LOOSE. AT EXPLANT, DOCTOR FOUND THAT HIS SUTURE HAD BROKEN, ALLOWING ONE OF THE TABS TO COME LOOSE AND WAS FREE TO FLAP. DOCTOR HAD USED A SINGLE SUTURE TECHNIQUE WITH 2 HORIZONTAL AND 1 VERTICLE STITCH AT EACH TAB. BECAUSE, THE TAB HAD STARTED WEARING ON THE NATIVE TISSUE DURING FLAPPING, THE DOCTOR DID NOT FEEL HE SHOULD IMPLANT ANOTHER 3F VALVE. SO, HE CUT OUT THE LEAFLETS AND IMPLANTED A MAGNA, 25MM, INSIDE THE 3F SEWING CUFF. PT 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