BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MOSAIC AORTIC BIOPROSTHETIC HEART VALVE

    MDR report key: 10983540 · Received December 10, 2020

    Report

    Report Number
    2025587-2020-03736
    Event Type
    Injury
    Date Received
    December 10, 2020
    Date of Event
    July 7, 2020
    Report Date
    December 10, 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: SMALL A., ET AL. COMBINED TRANSCATHETER TRICUSPID AND PULMONARY VALVE REPLACEMENT. WORLD J PEDIATR CONGENIT HEART SURG, 2020 JUL;11(4):432-437. DOI: 10.1177/2150135120918777. PMID: 32645786. FIRST PUBLISHED JULY 7, 2020. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. MEDTRONIC PRODUCTS REFERENCED: MOSAIC (PMA# P990064, PRODUCT CODE: DYE), MELODY (PMA# P140017, PRODUCT CODE: NPV). 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 COMBINED TRANSCATHETER REPLACEMENT OF THE TRICUSPID AND PULMONIC VALVES IN PATIENTS WITH CONGENITAL HEART DISEASE OR CARCINOID SYNDROME. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER. THE STUDY POPULATION INCLUDED 5 PATIENTS (MEAN AGE 46 YEARS), 2 OF WHOM WERE IMPLANTED WITH 22-MM MEDTRONIC MELODY BIOPROSTHETIC VALVES AT THE TRICUSPID AND PULMONIC VALVE POSITIONS (NO SERIAL NUMBERS PROVIDED). ONE PATIENT IN THE STUDY HAD PREVIOUSLY BEEN IMPLANTED WITH 29-MM MEDTRONIC MOSAIC BIOPROSTHETIC VALVES AT THE TRICUSPID AND PULMONIC POSITIONS (NO SERIAL NUMBER PROVIDED). ONE PATIENT IMPLANTED WITH MEDTRONIC MELODY VALVES EXPIRED FROM REFRACTORY HEART FAILURE 2.5 YEARS AFTER INITIAL COMBINED VALVE REPLACEMENTS. TWELVE MONTHS AFTER INITIAL VALVE REPLACEMENTS, THE PATIENT DEVELOPED PROGRESSIVE SEVERE TRICUSPID REGURGITATION WITH AN ECHOGENIC MASS NOTED ON THE ANNULUS. THE PATIENT WAS TREATED WITH ANTICOAGULANTS AND INTRAVENOUS ANTIBIOTICS FOR SUSPECTED VALVE THROMBOSIS AND ENDOCARDITIS. THE PATIENT REQUIRED REPEAT TRICUSPID TRANSCATHETER VALVE REPLACEMENT AT THAT TIME. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE DEATH. FOR THE PATIENT PREVIOUSLY IMPLANTED WITH THE MEDTRONIC MOSAIC VALVES, ADVERSE EVENTS INCLUDED: MODERATE TRICUSPID REGURGITATION, SEVERE PULMONARY REGURGITATION AND RIGHT VENTRICULAR SYSTOLIC DYSFUNCTION, REQUIRING VALVE REPLACEMENT AT BOTH POSITIONS WITH NON-MEDTRONIC VALVES. 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
    1451057 MOSAIC AORTIC BIOPROSTHETIC HEART VALVE HEART-VALVE, REPLACEMENT DYE MEDTRONIC HEART VALVES DIVISION 30519

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Life Threatening| R UNKNOWN IPG