BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHER PULMONARY VALVE

    MDR report key: 6335591 · Received February 16, 2017

    Report

    Report Number
    2025587-2017-00257
    Event Type
    Injury
    Date Received
    February 16, 2017
    Date of Event
    August 18, 2016
    Report Date
    January 17, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SOSNOWSKI C ET AL. HYBRID PULMONARY ARTERY PLICATION FOLLOWED BY TRANSCATHETER PULMONARY VALVE REPLACEMENT: COMPARISON WITH SURGICAL PVR. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 2016; 88: 804¿810. 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.

    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 REGARDING HYBRID PULMONARY VALVE REPLACEMENT (PVR) COMBINING SURGICAL PLICATION OF THE MAIN PULMONARY ARTERY FOLLOWED BY TRANSCATHETER PVR. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JUNE 2012 AND JUNE 2015. THE STUDY POPULATION INCLUDED 21 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 31 YEARS), 8 OF WHICH WERE IMPLANTED WITH MEDTRONIC MELODY VALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: ONE VALVE DISLODGEMENT AND THREE MILD PULMONARY REGURGITATION. THE VALVE DISLODGEMENT OCCURRED DURING REMOVAL OF DELIVERY CATHETER SYSTEM (DCS) FOLLOWING VALVE DEPLOYMENT WHERE THE ¿CARROT¿ OF THE DCS BECAME CAUGHT ON THE VALVE STENT. VIGOROUS REMOVAL EFFORTS RESULTED IN VALVE MOVEMENT AWAY FROM THE INITIAL IMPLANT SITE. THE VALVE COULD NOT BE OPTIMALLY REPOSITIONED, THEREFORE THE PROCEDURE WAS CONVERTED TO SURGICAL PVR. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119383 MELODY TRANSCATHER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention