BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 12277882 · Received August 4, 2021

    Report

    Report Number
    2025587-2021-02454
    Event Type
    Injury
    Date Received
    August 4, 2021
    Date of Event
    April 29, 2021
    Report Date
    August 4, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BREATNACH CR ET AL. PROCEDURAL TECHNIQUE FOR HYBRID PULMONARY VALVE REPLACEMENT IN INFANTS AND SMALL CHILDREN. EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY. 2021; 59:823-830. DOI: 10.1093/EJCTS/EZAA410. 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 RETROSPECTIVE ANALYSIS INTO A HYBRID TECHNIQUE OF PULMONARY VALVE REPLACEMENT IN A PEDIATRIC POPULATION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN MAY 2017 AND APRIL 2019. THE STUDY POPULATION INCLUDED 10 PATIENTS (PREDOMINANTLY FEMALE, MEDIAN AGE 1.5 YEARS, MEDIAN WEIGHT 8.8 KG), ALL OF WHOM WERE IMPLANTED WITH MEDTRONIC MELODY TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL MEDTRONIC MELODY PATIENTS, ADVERSE EVENTS INCLUDED: SEPSIS LEADING TO INFECTIVE ENDOCARDITIS (1 PATIENT), WOUND INFECTION (1 PATIENT), SEVERE PULMONARY REGURGITATION (1 PATIENT), AND PARAVALVULAR LEAK (2 PATIENTS) REQUIRING BALLOON ANGIOPLASTY OR A SECOND VALVE. 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
    1174303 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 18 MO Hospitalization| R