BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA

    MDR report key: 23855537 · Received December 19, 2025

    Report

    Report Number
    2025587-2025-06052
    Event Type
    Injury
    Date Received
    December 19, 2025
    Date of Event
    July 3, 2022
    Report Date
    December 19, 2025
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MICHAEL J. LEWIS ET AL. LONG-TERM FOLLOW-UP OF RIGHT VENTRICLE TO PULMONARY ARTERY BIOLOGIC VALVED CONDUITS USED IN PEDIATRIC CONGENITAL HEART SURGERY. PEDIATRIC CARDIOLOGY VOL 44:102¿115 2023. 10.1007/S00246-022-02956-3 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 LONG-TERM FOLLOW-UP OF RIGHT VENTRICLE TO PULMONARY ARTERY BIOLOGIC VALVED CONDUITS USED IN PEDIATRIC CONGENITAL HEART SURGERY. THE STUDY POPULATION INCLUDED 455 PATIENTS WITH A MEAN AGE OF 6 YEARS WHO WERE PREDOMINANTLY MALE. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION; 192 PATIENTS WERE IMPLANTED WITH A MEDTRONIC CONTEGRA CONDUIT. AMONG CONTEGRA CONDUIT PATIENTS ADVERSE EVENTS INCLUDED: ENDOCARDITIS AND REPLACMENT. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2627583 CONTEGRA PULMONIC VALVED CONDUIT MWH MEDTRONIC HEART VALVES DIVISION 200S

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Male Hospitalization| R