BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 14456996 · Received May 20, 2022

    Report

    Report Number
    2025587-2022-01406
    Event Type
    Injury
    Date Received
    May 20, 2022
    Date of Event
    September 11, 2021
    Report Date
    May 19, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: HADDAD, R. ET AL. A NEW SOLUTION FOR STENTING LARGE RIGHT VENTRICULAR OUTFLOW TRACTS BEFORE TRANSCATHETER PULMONARY VALVE REPLACEMENT. CANADIAN JOURNAL OF CARDIOLOGY. 2022. 38(1):31-40 DOI:10.1016/J.CJCA.2021.08.021. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT 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 · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING A MALE PATIENT WITH PULMONARY ATRESIA-INTACT VENTRICULAR SEPTUM WHO UNDERWENT IMPLANT OF A MEDTRONIC MELODY TRANSCATHETER PULMONARY VALVE (TPV) THAT WAS IMPLANTED WITHIN A SURGICAL BIOPROSTHETIC CONDUIT. UNIQUE DEVICE IDENTIFIER NUMBERS WERE NOT PROVIDED. AT 25 YEARS OF AGE, THE TPV HAD BECOME STENOSED WITH REGURGITATION. THE TPV WAS PRE-STENTED IN ORDER TO PLACE AN ADDITIONAL NON-MEDTRONIC TPV. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1618453 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Required Intervention