BEUDAMED
    FDA Adverse Event Death Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 24791793 · Received April 6, 2026

    Report

    Report Number
    9617601-2026-02284
    Event Type
    Death
    Date Received
    April 6, 2026
    Date of Event
    October 31, 2023
    Report Date
    April 6, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GJ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: SLOUHA E, JOHNSON LL, THIRUNAVUKARASU A, AL-GEIZI H, CLUNES LA, KOLLIAS TF. RISK OF INFECTIVE ENDOCARDITIS POST-TRANSCATHETER PULMONARY VALVE REPLACEMENT VERSUS SURGICAL PULMONARY VALVE REPLACEMENT: A SYSTEMATIC REVIEW. CUREUS. 2023;15(10):E48022. PUBLISHED 2023 OCT 31. DOI:10.7759/CUREUS.48022 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT AND DATE OF DEATH. 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. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING A SYSTEMATIC REVIEW OF INFECTIVE ENDOCARDITIS (IE) FOLLOWING TRANSCATHETER (TPVR) AND SURGICAL PULMONARY VALVE REPLACEMENT (SPVR). NINETEEN PUBLICATIONS WERE INCLUDED IN THE REVIEW, ENCOMPASSING A TOTAL OF 17,829 PATIENTS. MEDTRONIC (MELODY VALVE / CONTREGRA CONDUIT) AND NON-MEDTRONIC PULMONARY VALVE REPLACEMENT DEVICES WERE IMPLANTED IN THE POOLED PATIENT POPULATION. AS WRITTEN, THE AUTHORS DISCUSSED THE INCIDENCE, RISK FACTORS, ETIOLOGY/MANIFESTATION, TREATMENT, AND OUTCOMES OF IE AMONG TPVR AND SPVR PATIENTS. VARIOUS RATES OF IE IN MELODY AND CONTEGRA PATIENTS WERE CITED BY THE AUTHORS. TREATMENTS VARIED BETWEEN THE PUBLICATIONS BUT GENERALLY CONSISTED OF SURGICAL, PERCUTANEOUS, OR MEDICINAL INTERVENTIONS. ALSO, UNDER OUTCOMES, THE AUTHORS NOTED SEVERAL SURVIVAL AND MORTALITY RATES FOR IE PATIENTS FOLLOWING PVR, INCLUDING DEATHS ASSOCIATED WITH ENDOCARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849337 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI NPV MEDTRONIC MEXICO S. DE R.L. DE CV PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death