BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 13832098 · Received March 20, 2022

    Report

    Report Number
    2025587-2022-00745
    Event Type
    Injury
    Date Received
    March 20, 2022
    Date of Event
    January 24, 2022
    Report Date
    March 19, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: SAMAYOA J., ET AL. ECHOCARDIOGRAPHIC ASSESSMENT OF MELODY VERSUS SAPIEN VALVES FOLLOWING TRANSCATHETER PULMONARY VALVE REPLACEMENT. JACC CARDIOVASC INTERV. 2022 JAN 24;15(2):165-175. DOI: 10.1016/J.JCIN.2021.11.002. PMID: 35057987 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. 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 THE INTERMEDIATE/MID-TERM PERFORMANCE OF TWO COMPETITOR TRANSCATHETER PULMONARY VALVES, BASED UPON ECHOCARDIOGRAPHY. ALL DATA WERE RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN 2011 AND 2020. THE STUDY POPULATION INCLUDED 328 PEDIATRIC AND ADULT PATIENTS, WITH 202 OF THEM IMPLANTED WITH MEDTRONIC MELODY BIOPROSTHETIC VALVES (PREDOMINANTLY MALE, MEAN AGE 14.4 YEARS, MEAN WEIGHT 49.1 KG; UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL MEDTRONIC MELODY PATIENTS, ADVERSE EVENTS INCLUDED: TWO CASES OF ENDOCARDITIS WITH HIGH TRANSVALVULAR GRADIENTS AND PULMONARY STENOSIS (PS), REQUIRING SURGICAL EXPLANTATION AND PULMONARY VALVE REPLACEMENT. THE TIMELINE OF ENDOCARDITIS DEVELOPMENT WAS NOT REPORTED WITHIN THE ARTICLE. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT MAY HAVE BEEN ASSOCIATED WITH THE ADVERSE EVENTS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518227 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Required Intervention| L