BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC VALVE

    MDR report key: 11016863 · Received December 16, 2020

    Report

    Report Number
    2025587-2020-03812
    Event Type
    Injury
    Date Received
    December 16, 2020
    Date of Event
    July 1, 2020
    Report Date
    December 15, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GONG F., ET AL. OPTIMAL IMAGING GUIDANCE DURING TRANSCATHETER MITRAL VALVE-IN-VALVE REPLACEMENT IN BIOPROSTHESES WITH RADIOLUCENT SEWING RINGS. J AM COLL CARDIOL CASE REP., 2020 JULY; 2(8):1129¿1134. DOI.ORG/10.1016/J.JACCAS.2020.05.073. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. MEDTRONIC PRODUCTS REFERENCED: MOSAIC (PMA# P990064, PRODUCT CODE: DYE). 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 OF A CASE REPORT REGARDING OPTIMAL IMAGING GUIDANCE FOR VALVE-IN-VALVE TRANSCATHETER MITRAL VALVE REPLACEMENT (VIV TMVR). A (B)(6)-YEAR-OLD MALE PATIENT WITH PRIOR AORTIC/MITRAL BIOPROSTHETIC VALVE REPLACEMENTS PRESENTED TO THE HOSPITAL WITH A ONE-YEAR HISTORY OF DYSPNEA ON EXERTION. TRANSTHORACIC AND TRANSESOPHAGEAL ECHOCARDIOGRAMS (TTE/TEE) REVEALED SEVERE MITRAL REGURGITATION DUE TO A FLAIL LEAFLET INVOLVING THE 29-MM MEDTRONIC MOSAIC VALVE, REDUCED LEFT VENTRICULAR SYSTOLIC FUNCTION, MODERATE RIGHT VENTRICULAR IMPAIRMENT AND SEVERE PULMONARY HYPERTENSION (NO SERIAL NUMBER PROVIDED). HE UNDERWENT VIV TMVR USING A NON-MEDTRONIC VALVE WITH GOOD RECOVERY AND FOLLOW-UP. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482154 MOSAIC MITRAL BIOPROSTHETIC VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION 310-29

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| R