BEUDAMED
    FDA Adverse Event Death Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 10903783 · Received November 25, 2020

    Report

    Report Number
    2025587-2020-03621
    Event Type
    Death
    Date Received
    November 25, 2020
    Date of Event
    March 30, 2015
    Report Date
    November 25, 2020
    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

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: FINCH W, ET AL. TRANSCATHETER MELODY VALVE PLACEMENT IN LARGE DIAMETER BIOPROSTHESES AND CONDUITS: WHAT IS THE OPTIMAL ¿LANDING ZONE¿? CATHETER CARDIOVASC INTERV. 2015 NOV;86(5):E217-23. DOI: 10.1002/CCD.25922. EPUB 2015 MAR 30. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE AND DEATH DATE. 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 · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING USE OF TRANSCATHETER VALVES WITHIN FAILED BIOPROSTHETIC VALVES (BPV) LOCATED IN THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). THE AIM WAS DETERMINING THE OPTIMAL SIZE OF THE BPV CONDUIT PRIOR TO CONDUCTING TRANSCATHETER IMPLANTATION FOR BEST OUTCOMES. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN OCTOBER 2010 AND JUNE 2014. THE STUDY POPULATION INCLUDED 52 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 21 YEARS), ALL OF WHOM WERE IMPLANTED WITH MEDTRONIC MELODY BIOPROSTHETIC VALVES (NO SERIAL NUMBERS PROVIDED). AMONG ALL MEDTRONIC MELODY PATIENTS, ONE DEATH OCCURRED DIRECTLY DUE TO INFECTIVE ENDOCARDITIS INVOLVING THE MELODY VALVE. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE DEATH. AMONG ALL MEDTRONIC MELODY PATIENTS, ADVERSE EVENTS INCLUDED: ONE CASE OF FEMORAL ARTERY DISSECTION DURING IMPLANTATION AND TRIVIAL-MILD PULMONARY VALVE REGURGITATION NOTED DURING LONG-TERM FOLLOW-UP. BASED ON THE AVAILABLE INFORMATION 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
    1368532 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Death