BEUDAMED
    FDA Adverse Event Death Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 7422938 · Received April 11, 2018

    Report

    Report Number
    2025587-2018-00840
    Event Type
    Death
    Date Received
    April 11, 2018
    Date of Event
    March 9, 2018
    Report Date
    April 24, 2018
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERILIZATION PROCESS USED BY MEDTRONIC HAS AN ANTI-MICROBIAL KILL ON THE MICROORGANISMS SUCH AS STAPHYLOCOCCUS AND STREPTOCOCCUS SPECIES. WITH THE LIMITED INFORMATION FROM THE ARTICLE, THE POTENTIAL CAUSES OF THE OBSERVATION CANNOT BE DETERMINED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CITATION: MALEKZADEH-MILANI S ET AL. FRENCH NATIONAL SURVEY ON INFECTIVE ENDOCARDITIS AND THE MELODY VALVE IN PERCUTANEOUS PULMONARY VALVE IMPLANTATION. ARCH CARDIOVASC DIS. (B)(6) 2018. PII: S1875-2136(18)30026-3. DOI: 10.1016/J.ACVD.2017.10.007. EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE . NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. 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 A FRENCH NATIONAL SURVEY ON INFECTIVE ENDOCARDITIS AND THE MELODY VALVE IN PERCUTANEOUS PULMONARY VALVE IMPLANTATION. ALL DATA WERE COLLECTED FROM MULTIPLE CENTERS BETWEEN 2008 AND 2016. THE STUDY POPULATION INCLUDED 43 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 26 YEARS), 5 OF WHICH WERE INITIALLY IMPLANTED WITH MEDTRONIC HANCOCK, 11 OF WHICH WERE INITIALLY IMPLANTED WITH MEDTRONIC CONTEGRA, AND 43 OF WHICH WERE IMPLANTED WITH MEDTRONIC MELODY VALVES VALVE-IN-VALVE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS THREE DEATHS OCCURRED. TWO DEATHS WERE DUE TO CARDIOGENIC SHOCK DUE TO RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) OBSTRUCTION AND STAPHYLOCOCCUS INFECTION. ONE DEATH WAS DUE TO SEPTIC SHOCK DUE TO STAPHYLOCOCCUS INFECTION. BASED ON THE AVAILABLE INFORMATION, ENDOCARDITIS WAS DIAGNOSED ACUTELY FOLLOWING THE IMPLANT OF A MEDTRONIC PRODUCT. THE RELATION OF THE PATIENT DEATHS TO THE VALVE WAS POSSIBLE. AMONG ALL PATIENTS IMPLANTED WITH THE HANCOCK CONDUIT, ADVERSE EVENTS INCLUDED: STENOSIS, REGURGITATION, AND AN INCREASED GRADIENT OF 43 MMHG, REQUIRING A VALVE-IN-VALVE IMPLANT. BASED ON THE AVAILABLE INFORMATION, THE STENOSIS, REGURGITATION, AND INCREASED GRADIENT WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS IMPLANTED WITH THE CONTEGRA CONDUIT, ADVERSE EVENTS INCLUDED: STENOSIS, REGURGITATION, AND INCREASED GRADIENT OF 43 MMHG, REQUIRING A VALVE-IN-VALVE IMPLANT. ENDOCARDITIS WAS ALSO REPORTED FIVE YEARS FOLLOWING THE IMPLANT. BASED ON THE AVAILABLE INFORMATION, THE STENOSIS, REGURGITATION, AND INCREASED GRADIENT WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS IMPLANTED WITH THE MELODY TRANSCATHETER PULMONARY BIOPROSTHETIC VALVE (TPBV), ADVERSE EVENTS INCLUDED: ENDOCARDITIS, PULMONARY HYPERTENSION, INCREASED GRADIENT, PULMONARY REGURGITATION, AND RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) OBSTRUCTION REQUIRING A SURGICAL OR PERCUTANEOUS INTERVENTION. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265363 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Death