BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA PULMONARY VALVED CONDUIT

    MDR report key: 9862348 · Received March 20, 2020

    Report

    Report Number
    2025587-2020-00895
    Event Type
    Injury
    Date Received
    March 20, 2020
    Date of Event
    October 8, 2019
    Report Date
    March 20, 2020
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: CHAU A ET AL. MULTIMODALITY CARDIOVASCULAR IMAGING IN THE DIAGNOSIS AND MANAGEMENT OF PROSTHETIC VALVE INFECTIVE ENDOCARDITIS IN CHILDREN REPORT OF TWO CASES AND BRIEF REVIEW OF THE LITERATURE. CARDIOL YOUNG. 2019 DEC;29(12):1526-1529. DOI: 10.1017/S1047951119002233. EPUB 2019 OCT 8. EARLIEST DATE OF PUBLISH USED FOR EVENT DATE. 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 THE 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 · 1

    MEDTRONIC RECEIVED INFORMATION VIA A LITERATURE CASE REPORT REGARDING A FEMALE PATIENT WHO WAS BORN WITH TETRALOGY OF FALLOT AND PULMONARY ATRESIA. AT (B)(6) YEAR OF AGE, THE PATIENT UNDERWENT COMPLETE REPAIR INVOLVING CLOSURE OF THE VENTRICULAR SEPTAL DEFECT AND IMPLANTATION OF A CONDUIT (MANUFACTURER NOT IDENTIFIED) BETWEEN THE RIGHT VENTRICLE AND PULMONARY ARTERY. AT (B)(6) YEARS OF AGE, THE PATIENT¿S INITIAL CONDUIT WAS REPLACED WITH A 16 MM MEDTRONIC CONTEGRA VALVED CONDUIT (SERIAL NUMBER NOT PROVIDED). AT (B)(6) YEARS OF AGE, THE PATIENT UNDERWENT TRANSCATHETER VALVE-IN-VALVE IMPLANTATION WITH A MEDTRONIC MELODY BIOPROSTHETIC VALVE (SERIAL NUMBER NOT PROVIDED) DUE TO STENOSIS OF THE CONTEGRA CONDUIT. AT (B)(6) YEARS OF AGE, THE PATIENT WAS ADMITTED WITH A FEVER OF UNKNOWN ORIGIN THAT HAD PERSISTED FOR A WEEK PRIOR TO HOSPITAL ADMISSION. TRANSTHORACIC ECHOCARDIOGRAPHY DID NOT SHOW INTRACARDIAC VEGETATIONS BUT INDICATED INCREASED STENOSIS ACROSS THE VALVE OF THE RIGHT VENTRICLE TO PULMONARY ARTERY CONDUIT. BLOOD CULTURES GREW (B)(6). CONTINUOUS INTRAVENOUS ANTIBIOTIC THERAPY WAS INITIATED. THE PATIENT¿S SIX-DAY HOSPITAL COURSE WAS COMPLICATED BY FLUID OVERLOAD WITH LOW ALBUMIN, ASCITES, PLEURAL EFFUSION, SEPSIS, AND BLOOD CULTURES THAT CONTINUED TO TEST (B)(6) DESPITE THE ANTIBIOTIC TREATMENT. A CHEST COMPUTED TOMOGRAPHY ANGIOGRAM REVEALED A SUSPECTED THROMBUS AS OPPOSED TO VEGETATION ASSOCIATED WITH THE IMPLANTED CONDUIT VALVE. SUBSEQUENTLY, THE MELODY VALVE AND CONTEGRA CONDUIT WERE SURGICALLY REMOVED AND REPLACED WITH A PULMONARY HOMOGRAFT. IT WAS CONFIRMED THAT A LARGE VEGETATION WAS IDENTIFIED DURING THE SURGERY AND WAS REMOVED WITH THE MELODY VALVE AND CONTEGRA CONDUIT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324770 CONTEGRA PULMONARY VALVED CONDUIT CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION 200S

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention