BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED

    MDR report key: 14940533 · Received July 6, 2022

    Report

    Report Number
    2025587-2022-01852
    Event Type
    Injury
    Date Received
    July 6, 2022
    Date of Event
    December 15, 2021
    Report Date
    July 6, 2022
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CITATION: MARATHE S., ET AL. COMPARISON OF HOMOGRAFTS AND BOVINE JUGULAR VEIN CONDUITS IN THE PULMONARY POSITION IN PATIENTS 20 YEARS OF AGE. J THORAC CARDIOVASC SURG. 2021 DEC 15;S0022-5223(21)01745-1. DOI: 10.1016/J.JTCVS.2021.11.087. PMID: 35058063. ONLINE AHEAD OF PRINT. EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. MEDTRONIC PRODUCTS REFERENCED: CONTEGRA (PMA# H020003, PRODUCT CODE: MWH). EARLIEST APPROVED PRODUCT USED FOR PRODUCT CODE AND PMA#. 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING COMPARING THE PERFORMANCE OF PULMONARY HOMOGRAFTS AND BOVINE JUGULAR CONDUITS (BJV) IN PEDIATRIC AND YOUNG ADULT PATIENTS WITH CONGENITAL HEART DISEASE. ALL DATA WERE COLLECTED FROM THREE MEDICAL CENTERS IN AUSTRALIA BETWEEN JANUARY 2000 AND DECEMBER 2018. THE STUDY POPULATION INCLUDED 586 PATIENTS WHO WERE PREDOMINANTLY MALE WITH A MEAN AGE OF 8 YEARS AND MEAN WEIGHT OF 28 KILOGRAMS. MULTIPLE MANUFACTURER¿S DEVICES WERE IMPLANTED IN THE STUDY POPULATION. AMONG ALL PATIENTS, 303 WERE IMPLANTED WITH A MEDTRONIC CONTEGRA VALVED CONDUIT (UNIQUE DEVICE IDENTIFIER NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, 42 DEATHS OCCURRED, HOWEVER THE CAUSES WERE NOT REPORTED. IT WAS NOTED WITHIN THE ARTICLE THAT THE TYPES OF PULMONARY VALVE GRAFTS AND CONDUITS USED IN THE STUDY WERE NOT SIGNIFICANT VARIABLES CONTRIBUTING TO THE PATIENT DEATHS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS NOT DIRECTLY ASSOCIATED WITH THE DEATHS. AMONG ALL MEDTRONIC CONTEGRA PATIENTS, ADVERSE EVENTS INCLUDED: STRUCTURAL/NON-STRUCTURAL VALVE DEGENERATION (SVD), LEADING TO MODERATE-SEVERE PULMONARY REGURGITATION, REQUIRING RE-INTERVENTION AND REPLACEMENT; VALVE THROMBOSIS AND BLEEDING EVENTS. BASED ON THE AVAILABLE INFORMATION MEDTRONIC PRODUCT WAS DIRECTLY ASSOCIATED WITH THE ADVERSE EVENTS. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422949 CONTEGRA PULMONARY VALVED CONDUIT - SUPPORTED PULMONIC VALVED CONDUIT MWH MEDTRONIC HEART VALVES DIVISION 200S

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Male Required Intervention