BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MELODY TRANSCATHETER PULMONARY VALVE

    MDR report key: 21521259 · Received March 4, 2025

    Report

    Report Number
    2025587-2025-01641
    Event Type
    Injury
    Date Received
    March 4, 2025
    Date of Event
    January 17, 2025
    Report Date
    March 4, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPV
    PMA / PMN Number
    P140017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: ANDREA R. HSU ET AL. INCIDENCE AND OUTCOMES OF PROSTHETIC VALVE ENDOCARDITIS IN ADULTS WITH CONGENITAL HEART DISEASE. AM HEART J JAN 16:S0002-8703(25)00006-7. 2025. 10.1016/J.AHJ.2025.01.005. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. 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 INCIDENCE AND OUTCOMES OF PROSTHETIC VALVE ENDOCARDITIS IN ADULTS WITH CONGENITAL HEART DISEASE. THE STUDY POPULATION INCLUDED 3,150 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 38 YEARS OLD. OF THOSE PATIENTS, 149 WERE IMPLANTED WITH A PROSTHETIC VALVE. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 73 PATIENTS RECEIVED A MEDTRONIC MELODY BIOPROSTHETIC VALVE. AMONG ALL PATIENTS, 21 WITH PROSTHETIC VALVE ENDOCARDITIS DIED DURING FOLLOW-UP. THE AUTHORS STATED THAT PROSTHETIC VALVE ENDOCARDITIS WAS ASSOCIATED WITH A MORE THAN A TWO-FOLD INCREASE IN ALL-CAUSE MORTALITY AFTER ADJUSTMENT FOR DEMOGRAPHIC/ANATOMIC INDICES AND COMORBIDITIES. AMONG ALL PATIENTS, NON-DEATH CLINICAL OBSERVATIONS INCLUDED: PROSTHETIC VALVE ENDOCARDITIS (AVERAGE TIME FROM IMPLANT TO DIAGNOSIS WAS 7.58 YEARS), PERIVALVULAR ABSCESS, PERIVALVULAR FISTULA, MYCOTIC ANEURYSMS, SEPTIC EMBOLI, ATRIAL ARRHYTHMIA, MODERATE TO SEVERE AORTIC/PULMONARY/TRICUSPID/MITRAL REGURGITATION, AND SURGICAL INTERVENTION TO EXPLANT THE PROSTHETIC VALVE. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2276366 MELODY TRANSCATHETER PULMONARY VALVE PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELI NPV MEDTRONIC HEART VALVES DIVISION PB 10

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male Hospitalization| C| L| R