BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 7125627 · Received December 18, 2017

    Report

    Report Number
    2025587-2017-02473
    Event Type
    Injury
    Date Received
    December 18, 2017
    Date of Event
    October 19, 2017
    Report Date
    December 18, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: TAGGART, NM. MD ET AL. OUTCOMES OF TRANSCATHETER TRICUSPID VALVE-IN-VALVE IMPLANTATION IN PATIENTS WITH EBSTEIN ANOMALY. AMERICAN JOURNAL OF CARDIOLOGY (2017) OCT 19. PII: S0002-9149(17)31627-2 DOI 10.1016/J.AMJCARD.2017.10.017 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. (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW REGARDING OUTCOMES AFTER A TRICUSPID VALVE-IN-VALVE IMPLANT INTO A PREVISOUSLY IMPLANTED SURGICAL VALVE. ALL DATA WERE COLLECTED FROM A MULTI-CENTER, MULTI-COUNTRY REGISTRY BETWEEN 2008 AND 2016. THE STUDY POPULATION INCLUDED 81 PATIENTS, 52 OF WHICH WERE IMPLANTED WITH A MELODY TRANSCATHETER BIOPROSTHETIC VALVE. SERIAL NUMBERS WERE NOT PROVIDED. THE STUDY POPULATION WAS PREDOMINANTLY FEMALE; MEAN AGE 23 YEARS; MEAN WEIGHT 67 KG. AMONG ALL PATIENTS ADVERSE EVENTS INCLUDED: STENOSIS, TRICUSPID REGURGITATION, THROMBUS TREATED WITH BALLOON AORTIC VALVULOPLASTY (BAV), SURGICAL REPLACEMENT OR VALVE-IN-VALVE, PATIENT PROSTHESIS MISMATCH, AND RETROPERITONEAL HEMATOMA. OTHER ADVERSE EVENTS INCLUDED; ENDOCARDITIS TREATED WITH SURGICAL REPLACEMENT OR MEDICATION. THE CAUSATIVE ORGANISMS WERE IDENTIFIED AS STAPHYLOCOCCUS AUREUS, ENTEROCOCCUS FAECALIS, AND CANDIDA ALBICANS. BASED ON THE AVAILABLE INFORMATION, THESE EVENTS MAY HAVE BEEN ATTRIBUTED TO A MEDTRONIC PRODUCT. HOWEVER AS MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE, A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND THE MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903986 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention