BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 5319006 · Received December 22, 2015

    Report

    Report Number
    2025587-2015-01368
    Event Type
    Injury
    Date Received
    December 22, 2015
    Date of Event
    November 30, 2013
    Report Date
    December 4, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TITLE: INFECTIVE ENDOCARDITIS FOLLOWING PERCUTANEOUS PULMONARY VALVE REPLACEMENT: DIAGNOSTIC CHALLENGES AND APPLICATION OF INTRA-CARDIAC ECHOCARDIOGRAPHY CITATION: INTERNATIONAL JOURNAL OF CARDIOLOGY 169 (2013) 425¿429 .AUTHORS: GARY CHEUNG, NIELS VEJLSTRUP, NIKOLAJ IHLEMANN, SAMER ARNOUS, OLAF FRANZEN, HENNING BUNDGAARD, LARS SØNDERGAARD. DATE OF PUBLISH WAS 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW THAT A RETROSPECTIVE STUDY WAS PERFORMED TO EVALUATE ENDOCARDITIS AFTER THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC PULMONARY VALVE. THE STUDY WAS CONDUCTED BETWEEN NOVEMBER 2006 AND NOVEMBER 2012. THE STUDY POPULATION INCLUDED 42 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 25 YEARS), AND 43 IMPLANTS OF A MEDTRONIC MELODY DEVICE. SERIAL NUMBERS WERE NOT REPORTED. THE REASON FOR THE 43RD VALVE WAS NOT REPORTED. ACROSS ALL PATIENTS, ONE DEATH, DUE TO SUDDEN CARDIAC DEATH, OCCURRED TWO YEARS AFTER THE DIAGNOSIS OF ENDOCARDITIS. THERE WAS NO ALLEGATION THAT THE ENDOCARDITIS NINE MONTHS POST IMPLANT AND DEATH TWO YEARS POST IMPLANT WAS CAUSED BY THE DEVICE. ACROSS ALL PATIENTS, THE FOLLOWING ADVERSE EVENTS OCCURRED; 6 INCIDENTS OF SUSPECTED ENDOCARDITIS. UPON TRANSTHORACIC AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) FOLLOW UP, ENDOCARDITIS COULD NOT BE CONFIRMED AND THEREFORE WERE DIAGNOSED WITH POSSIBLE CASES OF ENDOCARDITIS PER THE MODIFIED (B)(4) CRITERIA. UPON INTRA-CARDIAC ECHOCARDIOGRAM OF TWO PATIENTS WHO DID NOT RESPOND TO ANTIBIOTIC TREATMENT, VEGETATIONS WERE CONFIRMED. THESE 2 PATIENTS WERE TREATED WITH SURGICAL EXPLANT. THE OTHER 4 PATIENTS WERE TREATED WITH ANTIBIOTICS. THE EARLIEST CASE OF ENDOCARDITIS WAS NINE MONTHS POST-IMPLANT. OTHER ADVERSE EVENTS INCLUDED; 3 INCIDENTS OF MODERATE PULMONARY STENOSIS, 2 INCIDENTS OF MILD STENOSIS. THE REPORTED ORGANISMS WERE STAPHYLOCOCCUS AUREUS (2), STAPHYLOCOCCUS EPIDERMIDIS (1) AND STREPTOCOCCUS PNEUMONIAE (1), NON-HAEMOLYTIC STREPTOCOCCI AND STREPTOCOCCUS GORDONII (1). CONTEGRA IT WAS REPORTED THAT ONE MELODY DEVICE WAS IMPLANTED, VALVE-IN-VALVE, INTO A CONTEGRA DUE TO STENOSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843061 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB1016

    Patients

    Seq Age Sex Outcome Treatment
    1 00025 YR Required Intervention