BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 13818586 · Received March 19, 2022

    Report

    Report Number
    2025587-2022-00725
    Event Type
    Injury
    Date Received
    March 19, 2022
    Date of Event
    November 18, 2021
    Report Date
    March 18, 2022
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: GUYON, ET AL. EXPANDED USE OF THE ONE-STEP TECHNIQUE FOR SIMULTANEOUS LANDING ZONE STENTING AND PLACEMENT OF THE MELODY TRANSCATHETER PULMONARY VALVE. J INVASIVE CARDIOL. 2021 DEC;33(12):E954-E959. EPUB 2021 NOV 18. PMID: (B)(4). EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: MELODY (PMA# P140017, PRODUCT CODE: NPV). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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. UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING OUTCOMES FROM USING A NEW IMPLANT TECHNIQUE FOR TRANSCATHETER PULMONARY VALVE IMPLANTATION (TPVI). ALL DATA WERE COLLECTED FROM THREE ACADEMIC MEDICAL CENTERS BETWEEN 2017 AND 2020. THE STUDY POPULATION INCLUDED 64 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 21 YEARS), ALL OF WHOM WERE IMPLANTED WITH MEDTRONIC MELODY BIOPROSTHETIC VALVES (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL MEDTRONIC MELODY PATIENTS, ADVERSE EVENTS INCLUDED: JAILED/OCCLUDED RIGHT PULMONARY ARTERY BY THE VALVE, VALVE DISLODGEMENT REQUIRING IMPLANTATION A SECOND MELODY VALVE AND RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) CONDUIT TEAR/FISTULA. 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
    21676 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Male Required Intervention| L