BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 8932336 · Received August 26, 2019

    Report

    Report Number
    2025587-2019-02655
    Event Type
    Injury
    Date Received
    August 26, 2019
    Date of Event
    March 28, 2019
    Report Date
    August 26, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GHEORGHE L ET AL. TRANSCATHETER TRICUSPID VALVE INTERVENTIONS: AN EMERGING FIELD. CURR CARDIOL REP. 2019 MAR 28;21(5):37. DOI: 10.1007/S11886-019-1119-7. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. 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 THE 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 AN OVERVIEW AND CLINICAL PERSPECTIVE ON NOVEL TRANSCATHETER TRICUSPID VALVE INTERVENTIONS. ALL DATA WERE COLLECTED FROM A META-ANALYSIS REVIEW OF PREVIOUSLY PUBLISHED STUDIES. THE OVERALL STUDY POPULATION INCLUDED AN UNSPECIFIED NUMBER OF PATIENTS (DEMOGRAPHICS NOT PROVIDED), AN UNDISCLOSED NUMBER OF WHICH WERE IMPLANTED WITH MEDTRONIC MELODY BIOPROSTHETIC VALVES IN THE TRICUSPID POSITION (NO SERIAL NUMBERS PROVIDED). AMONG ALL 306 PATIENTS INCLUDED IN THE TRANSCATHETER TRICUSPID VALVE REPLACEMENT SUBSET (USING THE MELODY VALVE AND NON-MEDTRONIC TRANSCATHETER AORTIC VALVES), APPROXIMATELY 52 DEATHS OCCURRED DURING THE 3-YEAR FOLLOW-UP PERIOD. NO OTHER DETAILS WERE PROVIDED. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL 306 PATIENTS INCLUDED IN THE TRANSCATHETER TRICUSPID VALVE REPLACEMENT SUBSET, ADVERSE EVENTS INCLUDED: MODERATE PARAVALVULAR LEAK AND REINTERVENTION ON THE TRICUSPID VALVE. SPECIFIC NATURE OF REINTERVENTION WAS NOT REPORTED. 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
    726688 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention