BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 10409648 · Received August 14, 2020

    Report

    Report Number
    2025587-2020-02608
    Event Type
    Injury
    Date Received
    August 14, 2020
    Date of Event
    October 1, 2019
    Report Date
    August 14, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ADAMSON G., ET AL. SECONDARY REPAIR OF INCOMPETENT PULMONARY VALVES AFTER PREVIOUS SURGERY OR INTERVENTION: PATIENT SELECTION AND OUTCOMES. JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY, JUNE 2020; 159(6):2383-2392. DOI:HTTPS://DOI.ORG/10.1016/J.JTCVS.2019.06.110. AVAILABLE AHEAD OF PRINT OCT 1, 2019. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. [MEDTRONIC PRODUCTS REFERENCED: MOSAIC (PMA# P990064, PRODUCT CODE DYE). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#.] 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 SECONDARY REPAIR OF INCOMPETENT PULMONARY VALVES (PV) AFTER PRIOR SURGERY OR INTERVENTION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2010 AND 2017. THE STUDY POPULATION INCLUDED 85 PATIENTS (31 FOR PV REPAIR AND 54 FOR PV REPLACEMENT). ALL 54 PATIENTS WHO UNDERWENT PV REPLACEMENT (PREDOMINANTLY MALE, MEAN AGE 18 YEARS) WERE IMPLANTED WITH MEDTRONIC MOSAIC PORCINE BIOPROSTHETIC VALVE (NO SERIAL NUMBERS PROVIDED). AMONG ALL MEDTRONIC MOSAIC PATIENTS, ADVERSE EVENTS INCLUDED: MODERATE-SEVERE PULMONARY REGURGITATION AND MODERATE-SEVERE PULMONARY STENOSIS, REQUIRING RE-INTERVENTION. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN 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
    873608 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION 30519

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Life Threatening| R