BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHER PULMONARY VALVE

    MDR report key: 6641327 · Received June 14, 2017

    Report

    Report Number
    2025587-2017-00971
    Event Type
    Injury
    Date Received
    June 14, 2017
    Date of Event
    February 25, 2016
    Report Date
    May 31, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: GHOBRIAL J, ABOULHOSN J. IMPACT OF RIGHT-SIDED-CATHETER-BASED VALVE IMPLANTATION ON DECISION-MAKING IN CONGENITAL HEART DISEASE. CURR CARDIOL REP. 2016 APR;18(4):33. DOI: 10.1007/S11886-016-0712-2. EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE META-ANALYSIS REGARDING THE IMPACT OF RIGHT-SIDED CATHETER BASED VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS. THE STUDY POPULATION INCLUDED AN UNDETERMINED AMOUNT OF PATIENTS IMPLANTED WITH MEDTRONIC MELODY TRANSCATHETER PULMONARY VALVES (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: MODERATE STENOSIS, INCREASED GRADIENT, ENDOCARDITIS, VALVE-IN-VALVE IMPLANTATION, PULMONARY ARTERY RUPTURE, CORONARY ARTERY COMPRESSION, AORTIC COMPRESSION, AND VALVE EMBOLIZATION. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422262 MELODY TRANSCATHER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention