BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 8824373 · Received July 24, 2019

    Report

    Report Number
    2025587-2019-02330
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    January 1, 2017
    Report Date
    July 24, 2019
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: FRIGIOLA A ET AL. SURGICAL MITRAL VALVE REPLACEMENT WITH THE MELODY VALVE IN INFANTS AND CHILDREN: THE ITALIAN EXPERIENCE. EUROINTERVENTION. 2017 APR 20;12(17):2104-2109. DOI: 10.4244/EIJ-D-16-00853. EPUB JANUARY 2017. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE(MONTH AND YEAR VALID). 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 AN ASSESSMENT OF THE USE OF THE MELODY VALVE IN INFANTS WITH CONGENITAL MITRAL VALVE DISEASE WHO HAD UNDERGONE UNSUCCESSFUL SURGICAL MITRAL VALVE REPAIR. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN MARCH 2014 AND OCTOBER 2015. THE STUDY POPULATION INCLUDED 8 PATIENTS (4 MALE, 4 FEMALE; MEAN AGE 31 MONTHS; MEAN WEIGHT 10 KG), ALL OF WHICH WERE IMPLANTED WITH MEDTRONIC MELODY BIOPROSTHETIC VALVES IN THE MITRAL POSITION (NO SERIAL NUMBERS PROVIDED). AMONG ALL PATIENTS, 2 DEATHS OCCURRED. BOTH PATIENTS REQUIRED EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT FOLLOWING TRADITIONAL MITRAL VALVE REPAIR AND EACH OF THEM UNDERWENT SUCCESSFUL MELODY VALVE IMPLANTATION AS A POTENTIAL BAIL-OUT. HOWEVER, BOTH PATIENTS DIED DUE TO MULTI-ORGAN FAILURE. IT WAS REPORTED THE MELODY VALVES WERE FUNCTIONING PROPERLY. BASED ON THE AVAILABLE INFORMATION, MEDTRONIC PRODUCT NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: CATHETER-BASED BALLOON EXPANSION OF THE MELODY VALVE REQUIRED AT 7 MONTHS POST IMPLANT (1 CASE), MILD MITRAL VALVE INSUFFICIENCY (6 CASES), AND PARAVALVULAR LEAK (4 CASES OF UNKNOWN SEVERITY). IT WAS NOTED THAT 3 OF THE 4 CASES OF PARAVALVULAR LEAK RESOLVED OVER TIME. 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
    616182 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 31 MO Required Intervention