BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 7470570 · Received April 27, 2018

    Report

    Report Number
    2025587-2018-01013
    Event Type
    Injury
    Date Received
    April 27, 2018
    Date of Event
    October 1, 1999
    Report Date
    April 27, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BILLIE S. FYFE. PATHOLOGICAL ANALYSIS OF NONSTENTED FREESTYLE AORTIC ROOT BIOPROSTHESES TREATED WITH AMINO OLEIC ACID. SEMINARS IN THORACIC AND CARDIOVASCULAR SURGERY. 1999 OCTOBER; 11(4 SUPPL 1): 151-156. DOI: NOT AVAILABLE 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING PATHOLOGICAL ANALYSIS OF THE FREESTYLE AORTIC ROOT BIOPROSTHESIS TREATED WITH AMINO OLEIC ACID. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS. THE STUDY POPULATION INCLUDED 1,100 PATIENTS, 67 PATIENTS OF WHICH HAD THE FREESTYLE DEVICE EXPLANTED. THE STUDY POPULATION WAS PREDOMINANTELY MALE. SERIAL NUMBERS WERE NOT PROVIDED. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: BLOOD LOSS, IATROGENIC VALVE DAMAGE, ENDOCARDITIS, PARAVALVULAR LEAK (PVL), STENOSIS, REGURGITATION, CALCIFICATION, FISTULA, CUSP TEAR/CUSP SEPARATION, THROMBUS TREATED WITH VALVE EXPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311592 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention