BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 12805790 · Received November 12, 2021

    Report

    Report Number
    2025587-2021-03431
    Event Type
    Injury
    Date Received
    November 12, 2021
    Date of Event
    February 15, 2021
    Report Date
    November 12, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ZABLAH JE, ET AL. NOVEL MINIMAL RADIATION APPROACH FOR PERCUTANEOUS PULMONARY VALVE IMPLANTATION. PEDIATR CARDIOL. 2021 AP R;42(4):926-933. DOI: 10.1007/S00246-021-02564-7. EPUB 2021 FEB 15. 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 FROM A LITERATURE ARTICLE REGARDING THE IMPACT OF USING MULTIMODALITY IMAGING TECHNOLOGY TO MINIMIZE RADIATION EXPOSURE DURING PERCUTANEOUS PULMONARY VALVE IMPLANTATION (PPVI). ALL DATA WAS RETROSPECTIVELY COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 2018 AND DECEMBER 2019. OF THE 76 PATIENTS INCLUDED IN THE STUDY POPULATION (PREDOMINANTLY MALE; MEDIAN AGE 16.5 YEARS; MEDIAN WEIGHT 52.8 KG), 14 UNDERWENT PPVI WITH A MEDTRONIC MELODY TRANSCATHETER PULMONARY VALVE SYSTEM. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: UNSTABLE PULMONARY VALVE AFTER AN INITIAL DEPLOYMENT REQUIRING RE-STENTING AND IMPLANT OF A SECOND PULMONARY VALVE DURING THE PPVI PROCEDURE (ONE CASE); HEMOMEDIASTINUM DIAGNOSED ON COMPUTED TOMOGRAPHY ONE MONTH AFTER PPVI THAT REQUIRED REINTERVENTION (ONE CASE); HOSPITAL RE-ADMISSION FOR CHEST PAIN AND ATELECTASIS THAT RESOLVED WITH MEDICAL MANAGEMENT (ONE CASE); AND ACCESS-SITE HEMATOMA (ONE CASE, NO INTERVENTION WAS REPORTED TO HAVE BEEN PERFORMED AS A RESULT). MEDTRONIC PRODUCT MAY HAVE BEEN 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
    1705303 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Male Hospitalization| R