BEUDAMED
    FDA Adverse Event Other Summary report: N

    ATS 3F AORTIC BIOPROSTHESIS

    MDR report key: 1725404 · Received June 9, 2010

    Report

    Report Number
    2031780-2010-00011
    Event Type
    Other
    Date Received
    June 9, 2010
    Date of Event
    May 5, 2010
    Report Date
    May 16, 2010
    Manufacturer
    ATS MEDICAL, 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 DESTROYED AT THE 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 APPROXIMATELY 8 1/2 MONTHS IMPLANTS DURATION BECAUSE IT REPORTEDLY CAME "LOOSE IN ONE SPOT". IT WAS REPLACED WITH A ST JUDE EPIC VALVE. DURING FOLLOW-UP DISCUSSIONS WITH THE EXPLANTING SURGEON, ATS LEARNED THAT THE LEFT/RIGHT TAB DEHISCED FROM/THROUGH THE AORTIC WALL COMPLETELY. THE VALVE STILL HAD THE TAB INTACT AND STILL HAD THE PLEDGET AND SUTURE CONNECTING THE TWO INTACT. THE SEWING RING DIRECTLY BENEATH THE LEFT/RIGHT TAB HAD ALSO DEHISCED FROM THE ANNULUS. THE DOCTOR COMMENTED THAT "STRUCTUALLY, THE VALVE WAS PERFECT". THE VALVE WAS DISCARDED BY THE HOSPITAL. THE 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