BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 14418464 · Received May 17, 2022

    Report

    Report Number
    2025587-2022-01375
    Event Type
    Injury
    Date Received
    May 17, 2022
    Date of Event
    August 10, 2021
    Report Date
    May 16, 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: MCELHINNEY D.; ET AL. MULTICENTER STUDY OF ENDOCARDITIS AFTER TRANSCATHETER PULMONARY VALVE REPLACEMENT. J AM COLL CARDIOL., 2021 AUG 10; 78(6):575-589. DOI: 10.1016/J.JACC.2021.05.044. PMID: 34353535. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: MELODY (PMA# P140017, PRODUCT CODE: NPV); CONTEGRA (PMA# H020003, PRODUCT CODE: MWH). 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 RISK FACTORS AND OUTCOMES OF ENDOCARDITIS AFTER TRANSCATHETER PULMONARY VALVE REPLACEMENT (TPVR). ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN JULY 2005 AND MARCH 2020. THE STUDY POPULATION INCLUDED 2,476 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 20 YEARS AND MEAN WEIGHT OF 61 KG. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. AMONG ALL PATIENTS, 215 PATIENTS HAD AN EXISTING MEDTRONIC CONTEGRA VALVED CONDUIT AS PART OF A PRIOR RIGHT VENTRICULAR OUTFLOW TRACT SURGICAL REPAIR. AMONG ALL PATIENTS, 2,038 PATIENTS UNDERWENT TPVR USING MEDTRONIC MELODY BIOPROSTHETIC VALVES (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). ECHOCARDIOGRAPHY AND DIRECT VISUALIZATION DURING SURGERY, AS WELL AS BLOOD CULTURES, WERE USED TO DIAGNOSE ENDOCARDITIS. AMONG ALL MEDTRONIC MELODY PATIENTS, 10 DEATHS OCCURRED, DUE TO BACTERIAL ENDOCARDITIS. MOST OF THE PATIENTS PRESENTED TO THE HOSPITAL IN EXTREMIS WITH MODERATE-SEVERE RVOT OBSTRUCTION, SEVERE RIGHT VENTRICULAR (RV) DYSFUNCTION WITH A NEED FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND/OR VENTRICULAR ASSIST DEVICE (VAD) SUPPORT. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL MEDTRONIC MELODY PATIENTS, ADVERSE EVENTS INCLUDED: BACTERIAL/FUNGAL ENDOCARDITIS REQUIRING HOSPITALIZATION, ANTIBIOTIC TR EATMENT, HEART CATHETERIZATION WITH STENT PLACEMENT AND SURGICAL/TRANSCATHETER PULMONARY VALVE REPLACEMENT. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE ADVERSE EVENTS. AMONG ALL MEDTRONIC CONTEGRA PATIENTS, ADVERSE EVENTS INCLUDED: BACTERIAL ENDOCARDITIS REQUIRING HOSPITALIZATION, ANTIBIOTIC TREATMENT, HEART CATHETERIZATION WITH STENT PLACEMENT AND SURGICAL/TRANSCATHETER PULMONARY VALVE REPLACEMENT; ELEVATED TRANSVALVULAR GRADIENTS AND MODERATE-SEVERE PULMONARY STENOSIS/OBSTRUCTION/REGURGITATION REQUIRING TPVR. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY 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
    1395859 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Male Hospitalization| R| L UNKNOWN IPG, UNKNOWN ICD