BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 5583481 · Received April 17, 2016

    Report

    Report Number
    2025587-2016-00528
    Event Type
    Injury
    Date Received
    April 17, 2016
    Date of Event
    April 1, 2014
    Report Date
    May 14, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    TITLE: ANTIMINERALIZATION TREATMENT AND PATIENT-PROSTHESIS MISMATCH ARE MAJOR DETERMINANTS OF THE ONSET AND INCIDENCE OF STRUCTURAL VALVE DEGENERATION IN BIOPROSTHETIC HEART VALVES CITATION: J THORAC CARDIOVASC SURG. 2014 APR;147(4):1219-24. AUTHORS: WILLEM FLAMENG, MD, PHD, FILIP REGA, MD, PHD, MONIQUEVERCALSTEREN, RN, PAUL HERIJGERS, MD, PHD, AND BART MEURIS, MD, PHD 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 THIS EVENT HAS BEEN PREVIOUSLY REPORTED. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE PHYSICIAN/AUTHOR STATED THAT NONE OF THE OBSERVED DEATHS OR ADVERSE EVENTS WERE CAUSED OR CONTRIBUTED TO BY MEDTRONIC PRODUCT. NO DEVICES WERE AVAILABLE FOR RETURN. NO SERIAL NUMBERS WERE PROVIDED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING A STUDY PERFORMED TO EVALUATE THE ONSET AND INCIDENCE OF VALVE DEGENERATION IN AORTIC BIOPROSTHESES THROUGH ECHOCARDIOGRAPHIC FOLLOW-UP. THE STUDY POPULATION INCLUDED 648 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 73.8 +/- 4.9 YEARS), 148 OF WHICH WERE IMPLANTED WITH MEDTRONIC MOSAIC (SERIAL NUMBERS NOT PROVIDED) AND 64 OF WHICH WERE IMPLANTED WITH MEDTRONIC FREESTYLE VALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS 37 IN-HOSPITAL DEATHS AND 26.3% MORTALITY AT 10 YEARS OCCURRED; NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCTS. DURING THE FOLLOW-UP PERIOD (MEAN 7.5 YEARS +/- 3.2 YEARS), THESE ADVERSE EVENTS WERE OBSERVED: 20 ACUTE BACTERIAL ENDOCARDITIS (WHO WERE EXCLUDED FROM FURTHER ANALYSIS), 4.2% THROMBOEMBOLIC AND/OR MAJOR ANTICOAGULATION-RELATED BLEEDING, AND 5.6% RE-OPERATIONS. ECHOCARDIOGRAPHIC FOLLOW-UP ALSO NOTED: 44 STENOSIS, 29 REGURGITATION, AND AN UNKNOWN NUMBER OF INCREASED GRADIENTS ASSOCIATED WITH STENOSIS AND/OR REGURGITATION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238642 FREESTYLE AORTIC ROOT BIOPROSTHESIS HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 995

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention