BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED

    MDR report key: 12753837 · Received November 4, 2021

    Report

    Report Number
    2025587-2021-03344
    Event Type
    Injury
    Date Received
    November 4, 2021
    Date of Event
    August 26, 2021
    Report Date
    November 4, 2021
    Product Code
    MWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: SHETH K., ET AL. EARLY MULTICENTER EXPERIENCE OF MELODY VALVE IMPLANTATION IN INDIA. ANN PEDIATR CARDIOL. JUL-SEP 2021;14(3):302-309. DOI: 10.4103/APC.APC_73_21. EPUB 2021 AUG 26. PMID: 34667400 EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: CONTEGRA (PMA# H020003, PRODUCT CODE: MWH); 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 AN INDIAN MULTICENTER EXPERIENCE WITH PERCUTANEOUS PULMONARY VALVE IMPLANTATION (PPVI) FOR PEDIATRIC PATIENTS WITH RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) DYSFUNCTION. ALL DATA WERE COLLECTED FROM FOUR MEDICAL CENTERS STARTING (B)(6) 2018. THE STUDY POPULATION INCLUDED 15 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 23 YEARS, WEIGHT RANGE 26-81 KG (MEDIAN WEIGHT 53.5 KG), ALL OF WHOM WERE IMPLANTED WITH MEDTRONIC MELODY BIOPROSTHETIC VALVES USING THE ENSEMBLE DELIVERY SYSTEM (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). THREE PATIENTS HAD PREVIOUSLY BEEN IMPLANTED WITH MEDTRONIC CONTEGRA VALVED CONDUITS (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL CONTEGRA PATIENTS, ADVERSE EVENTS INCLUDED: DEGENERATED VALVES LEADING TO RIGHT VENTRICULAR DYSFUNCTION, ELEVATED TRANSVALVULAR GRADIENTS AND SEVERE PULMONARY REGURGITATION/STENOSIS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE ADVERSE EVENTS. AMONG ALL MELODY PATIENTS, ONE PATIENT EXPERIENCED FOUR DAYS OF POST-PPVI FEVER ATTRIBUTED TO GLUTARALDEHYDE ELUTION FROM THE MELODY VALVE, WHICH WAS TREATED WITH NON-STEROID ANTI-INFLAMMATORY MEDICATION. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE ADVERSE EVENT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1653428 CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED PULMONIC VALVED CONDUIT MWH 200S

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention