BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 9758289 · Received February 26, 2020

    Report

    Report Number
    2025587-2020-00588
    Event Type
    Injury
    Date Received
    February 26, 2020
    Date of Event
    August 19, 2019
    Report Date
    February 26, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SIMONATO M ET AL. CURRENT GENERATION BALLOON-EXPANDABLE TRANSCATHETER VALVE POSITIONING STRATEGIES DURING AORTIC VALVE-IN-VALVE PROCEDURES AND CLINICAL OUTCOMES. JACC CARDIOVASC INTERV. 2019 AUG 26;12(16):1606-1617. DOI: 10.1016/J.JCIN.2019.05.057. AVAILABLE ONLINE 19 AUGUST 2019. 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 AN EVALUATION OF POSITIONING STRATEGIES WITH A NON-MEDTRONIC TRANSCATHETER BIOPROSTHETIC VALVE FOR TRANSCATHETER AORTIC VALVE-IN-VALVE IMPLANTATION. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM THE VALVE-IN-VALVE INTERNATIONAL DATA REGISTRY. THE STUDY POPULATION INCLUDED 113 PATIENTS AND WAS PREDOMINANTLY MALE WITH A MEAN AGE OF 77 YEARS AND A MEAN WEIGHT OF 80 KG. OF THOSE, 21 WERE IDENTIFIED AS HAVING BEEN PREVIOUSLY IMPLANTED WITH MEDTRONIC SURGICAL AORTIC VALVES: HANCOCK II (2) AND MOSAIC (19). NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: TRANSCATHETER VALVE-IN-VALVE IMPLANTATION DUE TO STENOSIS, MILD-MODERATE-SEVERE AORTIC REGURGITATION, OR A COMBINATION OF STENOSIS AND REGURGITATION; AND ELEVATED MEAN GRADIENTS (35 TO 60 MMHG). BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220519 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION 30519

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention