BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 6898560 · Received September 27, 2017

    Report

    Report Number
    2025587-2017-01700
    Event Type
    Injury
    Date Received
    September 27, 2017
    Date of Event
    October 1, 2001
    Report Date
    September 15, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: DEEB, MICHAEL, M.D. ET AL. REOPERATION FOR FREESTYLE STENTLESS AORTIC VALVES. SEMINARS IN THORACIC AND CARDIOVASCULAR SURGERY (2001) VOL 13 NO 4. 16-23. DOI: I 0.1053/S LCJ.2001.2970-1 EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE.   NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS 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 REVIEW REGARDING REOPERATION FOR FREESTYLE STENTLESS AORTIC VALVES. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN 1992 AND 2001. THE STUDY POPULATION INCLUDED 10 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 53.5 ± 14.1 YEARS), ALL OF WHICH WERE IMPLANTED WITH MEDTRONIC FREESTYLE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: REOPERATION DUE TO ENDOCARDITIS, AORTIC ANEURYSM, VALVE DEHISCENCE WITH MODERATE AORTIC INSUFFICIENCY, AND SUBVALVULAR OUTFLOW TRACT STENOSIS/OBSTRUCTION WITH PANNUS AND INCREASED GRADIENT MEASUREMENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676542 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention