BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA PULMONARY VALVED CONDUIT

    MDR report key: 12249123 · Received July 29, 2021

    Report

    Report Number
    2025587-2021-02410
    Event Type
    Injury
    Date Received
    July 29, 2021
    Date of Event
    April 1, 2021
    Report Date
    July 29, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: YAKUT K, ET AL. INFECTIVE ENDOCARDITIS IN CHILDHOOD: A SINGLE-CENTER EXPERIENCE OF 18 YEARS. BRAZ J CARDIOVASC SURG. 2021 APR 1;36(2):172-182. DOI: 10.21470/1678-9741-2020-0035. EARLIEST DATE OF PUBLISH 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE ARTICLE REGARDING THE CLINICAL, DIAGNOSTIC, AND MICROBIOLOGICAL CHARACTERISTICS OF PEDIATRIC PATIENTS WITH INFECTIVE ENDOCARDITIS. THE DATA OF 45 PATIENTS DIAGNOSED WITH DEFINITE OR POSSIBLE ENDOCARDITIS FOLLOWED UP AT A SINGLE CENTER BETWEEN MAY 2000 AND MARCH 2018 WERE RETROSPECTIVELY ANALYZED. OF THESE 45 PATIENTS (PREDOMINANTLY MALE, MEAN AGE 7.6 YEARS), 14 PATIENTS HAD A MEDTRONIC CONTEGRA VALVED CONDUIT IN THE PULMONARY POSITION. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. AMONG ALL PATIENTS, 14.8% OF THE ENDOCARDITIS EPISODES RESULTED IN DEATH. NO CORRELATION WAS MADE BETWEEN CONTEGRA AND THE DEATHS. AMONG ALL PATIENTS, 10% OF THE ENDOCARDITIS EPISODES DEVELOPED IN THE INITIAL SIX MONTHS AFTER CARDIAC SURGERY. ENDOCARDITIS-RELATED COMPLICATIONS INCLUDED: CONGESTIVE HEART FAILURE, SEPTIC PULMONARY INFARCTION, PULMONARY EMBOLISM, PNEUMONIA, PLEURAL EFFUSION, MAJOR ARTERIAL EMBOLISM, INTRACRANIAL EMBOLISM, PERICARDIAL EFFUSION, LEFT HEMIPARESIS, HEMOPTYSIS, MYCOTIC ANEURYSM, CONVULSION, PARESTHESIA IN THE LEFT LEG, SUPERIOR VENA CAVA OCCLUSION, AND TRICUSPID VALVE INJURY. ALL PATIENTS WERE TREATED WITH ANTIBIOTICS AND, IF NECESSARY, SURGICAL INTERVENTION. IN ADDITION, ONE PATIENT DEVELOPED COMPLETE ATRIOVENTRICULAR BLOCK AFTER TETRALOGY OF FALLOT REPAIR AND HAD A DUAL-CHAMBER PACEMAKER IMPLANTED. CONTEGRA MAY HAVE BEEN 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
    1142347 CONTEGRA PULMONARY VALVED CONDUIT PULMONIC VALVED CONDUIT MWH MEDTRONIC HEART VALVES DIVISION 200S

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Hospitalization| R