BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 8100302 · Received November 24, 2018

    Report

    Report Number
    2025587-2018-03165
    Event Type
    Injury
    Date Received
    November 24, 2018
    Date of Event
    April 3, 2018
    Report Date
    November 24, 2018
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: RODRIGUEZ-GABELLA ET AL. LONG-TERM OUTCOMES FOLLOWING SURGICAL AORTIC BIOPROSTHESIS IMPLANTATION. J AM COLL CARDIOL. 2018 APR 3;71(13):1401-1412. DOI: 10.1016/J.JACC.2018.01.059. 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. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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 LONG-TERM OUTCOMES OF CONSECUTIVE UNSELECTED SURGICAL AORTIC VALVE REPLACEMENT (SAVR) RECIPIENTS WITH A FOCUS ON EVALUATING CLINICAL OUTCOMES AND STRUCTURAL VALVE DEGENERATION (SVD) BASED ON ECHOCARDIOGRAPHIC CRITERIA. THE STUDY POPULATION INCLUDED 672 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 72 YEARS), 234 (34.8%) OF WHICH WERE IMPLANTED WITH MEDTRONIC MOSAIC AND 52 (7.7%) OF WHICH WERE IMPLANTED WITH MEDTRONIC FREESTYLE. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 432 (64.3%) DEATHS HAD OCCURRED AT A MEDIAN FOLLOW-UP OF 10 YEARS. OF THESE DEATHS, 151 (22.5%) WERE DEEMED CARDIAC DEATHS. ALSO 48 (7.1%) EARLY IN-HOSPITAL DEATHS OCCURRED. NO FURTHER DETAILS WERE PROVIDED ON THESE DEATHS. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT DID NOT CAUSE OR CONTRIBUTE THESE DEATHS AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: SVD, NONSTRUCTURAL VALVE DYSFUNCTION, AORTIC REGURGITATION, AORTIC STENOSIS, ENDOCARDITIS, VALVE THROMBOSIS, AORTIC DISSECTION, AND REINTERVENTION FOR VARIOUS REASONS. OVERALL, THE RATE OF CLINICALLY RELEVANT SVD WAS 6.6% AND SUBCLINICAL SVD WAS 30.1%. FOR MOSAIC, THE RATE OF CLINICALLY RELEVANT SVD WAS 5% AND SUBCLINICAL SVD WAS 29%. FOR FREESTYLE, THE RATE OF CLINICALLY RELEVANT SVD WAS 9% AND SUBCLINICAL SVD WAS 10%. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; HOWEVER, BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE CAUSED OR CONTRIBUTED TO THESE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939786 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE HEART VALVES SANTA ANA 305_MOSAIC

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention