BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC MITRAL BIOPROSTHETIC VALVE

    MDR report key: 11986344 · Received June 11, 2021

    Report

    Report Number
    2025587-2021-01863
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    April 26, 2021
    Report Date
    June 11, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    LWR
    PMA / PMN Number
    P990064
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GUERRERO M., ET AL. PROSPECTIVE EVALUATION OF TRANSSEPTAL TMVR FOR FAILED SURGICAL BIOPROSTHESIS: MITRAL TRIAL VALVE-IN-RING ARM 1-YEAR OUTCOMES. JACC CARDIOVASC INTERV. 2021 APR 26;14(8):859-872. PMID: 33888231. DOI: 10.1016/J.JCIN.2021.02.027 EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. [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 A CLINICAL TRIAL TO DETERMINE OUTCOMES AFTER TRANS-SEPTAL MITRAL VALVE-IN-RING REPLACEMENT (MVIR) FOR FAILED BIOPROSTHETIC VALVES. ALL DATA WERE PROSPECTIVELY COLLECTED FROM MULTIPLE MEDICAL CENTERS BETWEEN JULY 2016 AND OCTOBER 2017. THE TRANS-SEPTAL MVIR ARM OF THE STUDY POPULATION INCLUDED 30 PATIENTS (PREDOMINANTLY FEMALE, MEAN AGE 78 YEARS). SIX OF THESE PATIENTS HAD PREVIOUSLY UNDERGONE SURGICAL MITRAL VALVE REPLACEMENT USING MEDTRONIC MOSAIC BIOPROSTHETIC VALVES (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL MEDTRONIC MOSAIC PATIENTS, ADVERSE EVENTS INCLUDED: FAILED VALVES, LEADING TO SEVERE MITRAL STENOSIS/REGURGITATION WHICH REQUIRED MITRAL VALVE REPLACEMENTS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY 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
    880522 MOSAIC MITRAL BIOPROSTHETIC VALVE HEART-VALVE, NON-ALLOGRAFT TISSUE LWR MEDTRONIC HEART VALVES DIVISION 310

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R