BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 7024950 · Received November 13, 2017

    Report

    Report Number
    2025587-2017-02098
    Event Type
    Injury
    Date Received
    November 13, 2017
    Date of Event
    December 14, 2016
    Report Date
    November 13, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MOK, S. MD. ET AL. TWENTY-FIVE YEAR OUTCOMES FOLLOWING COMPOSITE GRAFT AORTIC ROOT REPLACEMENT. JOURNAL OF CARDIOVASCULAR SURGERY (2017) FEB;32(2):99-109; DOI 10.1111/JOCS.12875 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 EARLY AND LATE SURVIVAL, LONG-TERM FREEDOM FROM REOPERATION AND THE INCIDENCE OF LATE ADVERSE EVENTS. ALL DATA WERE COLLECTED FROM A SINGLE PHYSICIAN BETWEEN 1995 AND 2015. THE STUDY POPULATION INCLUDED 449 PATIENTS, WHICH WERE IMPLANTED WITH A MECHANICAL, BIOLOGICAL OR TISSUE VALVE OR A MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS. SERIAL NUMBERS WERE NOT PROVIDED. THE STUDY POPULATION WAS PREDOMINANTLY MALE; MEAN AGE 56.1 ± 14 YEARS. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: BLEEDING, CEREBROVASCULAR ACCIDENT/TRANSIENT ISCHEMIC ACCIDENT, RAPID ATRIAL FIBRILLATION, PERICARDIAL EFFUSION, INFECTION AND REOPERATION. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO A MEDTRONIC PRODUCT. HOWEVER AS MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    805254 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention