BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 8081466 · Received November 16, 2018

    Report

    Report Number
    2025587-2018-03089
    Event Type
    Injury
    Date Received
    November 16, 2018
    Date of Event
    January 22, 2018
    Report Date
    November 16, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: BANSAL N ET AL. BILATERAL BRANCH PULMONARY ARTERY VALVE IMPLANTATION IN REPAIRED TETRALOGY OF FALLOT. CATHETER CARDIOVASC INTERV. 2018 APR 1;91(5):911-919. DOI: 10.1002/CCD.27489. EPUB 2018 JAN 22. 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 THE SHORT AND MID-TERM RESULTS OF PATIENTS WITH REPAIRED TETRALOGY OF FALLOT WHO UNDERWENT BILATERAL BRANCH PULMONARY ARTERY VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 2011 AND AN UNDISCLOSED END DATE. THE STUDY POPULATION INCLUDED 8 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 39 YEARS; MEAN WEIGHT 76 KG), 5 OF WHICH HAD THE MEDTRONIC MELODY TRANSCATHETER PULMONARY VALVE IMPLANTED IN 9 BRANCH PULMONARY ARTERIES. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: STENT EMBOLIZATION IN THE MAIN PULMONARY ARTERY REQUIRING A SECOND STENT IMPLANTATION IN THE IPSILATERAL PULMONARY ARTERY AND LOW RIGHT VENTRICLE/LEFT VENTRICLE EJECTION FRACTION. MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN MEDTRONIC PRODUCT AND THE OBSERVED ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919688 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention