BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 14526939 · Received May 27, 2022

    Report

    Report Number
    2025587-2022-01503
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    January 28, 2019
    Report Date
    May 27, 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: YOON SH; ET AL. PREDICTORS OF LEFT VENTRICULAR OUTFLOW TRACT OBSTRUCTION AFTER TRANSCATHETER MITRAL VALVE REPLACEMENT. JACC CARDIOVASC INTERV., 2019 JAN 28;12(2):182-193. PMID: 30678797. DOI: 10.1016/J.JCIN.2018.12.001. EARLIEST DATE OF PUBLICATION 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. 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 PREDICTORS OF LEFT VENTRICULAR OUTFLOW TRACT (LVOT) OBSTRUCTION AFTER TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR). ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN FEBRUARY 2009 AND JANUARY 2018. THE STUDY POPULATION INCLUDED 194 PATIENTS WHO UNDERWENT PRE-PROCEDURAL COMPUTED TOMOGRAPHY (CT) SCANS AND ECHOCARDIOGRAPHIC STUDIES FOR TMVR PLANNING. THE PATIENTS WERE PREDOMINANTLY FEMALE WITH A MEAN AGE OF 76 YEARS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. AMONG ALL PATIENTS, ONE PATIENT UNDERWENT TRANSCATHETER VALVE-IN-VALVE (VIV) IMPLANTATION USING A MEDTRONIC MELODY BIOPROSTHETIC VALVE (UNIQUE DEVICE IDENTIFIER NUMBER NOT PROVIDED). IT WAS NOTED THAT NO PROCEDURAL DEATHS OCCURRED IN THE PATIENTS WHO UNDERWENT TRANSCATHETER VIV TMVR. AMONG ALL VIV TMVR PATIENTS, ADVERSE EVENTS INCLUDED: LVOT OBSTRUCTION, REQUIRINGMEDICAL MANAGEMENT AND VENTRICULAR SEPTAL WALL ALCOHOL ABLATION. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202330 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Life Threatening| R