BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 6764494 · Received August 3, 2017

    Report

    Report Number
    2025587-2017-01285
    Event Type
    Injury
    Date Received
    August 3, 2017
    Date of Event
    July 28, 2016
    Report Date
    July 6, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GHONEIM A ET AL. MANAGEMENT OF SMALL AORTIC ANNULUS IN THE ERA OF SUTURELESS VALVES: A COMPARATIVE STUDY AMONG DIFFERENT BIOLOGICAL OPTIONS. J THORAC CARDIOVASC SURG. 2016 OCT;152(4):1019-28. DOI: 10.1016/J.JTCVS.2016.06.058. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. (B)(4). A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING MANAGEMENT OF SMALL AORTIC ANNULUS IN THE ERA OF SUTURELESS PROSTHETIC VALVES. ALL DATA WERE COLLECTED RETROSPECTIVELY FROM A SINGLE CENTER BETWEEN JANUARY 2007 AND DECEMBER 2014. THE STUDY POPULATION INCLUDED 351 PATIENTS; 23 OF THESE PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 64.8 YEARS) WERE IMPLANTED WITH MEDTRONIC FREESTYLE STENTLESS PROSTHESES (SERIAL NUMBERS NOT PROVIDED). AMONG ALL FREESTYLE PATIENTS THREE DEATHS OCCURRED. BASED ON THE AVAILABLE INFORMATION, NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL FREESTYLE PATIENTS ADVERSE EVENTS INCLUDED: BLEEDING REQUIRING INTERVENTION, STROKE, ACUTE KIDNEY INJURY, AND PERMANENT PACEMAKER IMPLANT. BASED ON THE AVAILABLE INFORMATION, THESE ADVERSE EVENTS MAY HAVE BEEN ATTRIBUTED TO MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    544183 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention