BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE CONTEGRA

    MDR report key: 6850263 · Received September 7, 2017

    Report

    Report Number
    2025587-2017-01559
    Event Type
    Injury
    Date Received
    September 7, 2017
    Date of Event
    March 24, 2016
    Report Date
    August 15, 2017
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: SARIKOUCH, S. ET AL. DECELLULARIZED FRESH HOMOGRAFTS FOR PULMONARY VALVE REPLACEMENT: A DECADE OF CLINICAL EXPERIENCE. EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY. 2016; 50:281¿290 DOI 10.1093/EJCTS/EZW050 EARLIEST DATE OF E-PUBLISH/PUBLISH USED FOR EVENT DATE.   NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS BEEN PREVIOUSLY REPORTED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REVIEW THAT COMPARED THE USE OF DECELLULARIZED FRESH PULMONARY HOMOGRAFTS (DPHS), CRYOPRESERVED PULMONARY HOMOGRAFTS (CHS) AND BOVINE JUGULAR VEIN CONDUITS FOR PULMONARY VALVE REPLACEMENT. ALL DATA WERE COLLECTED FROM A MULTI-CENTER RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) REGISTRY BETWEEN 2005 AND 2015. THE STUDY POPULATION INCLUDED 3 COHORTS EACH OF 93 PATIENTS. THE COHORT OF THE BOVINE JUGULAR VEIN CONDUITS WERE PREDOMINANTLY FEMALE; MEAN AGE 15.6 ± 9.9 YEARS AND WERE IMPLANTED WITH A CONTEGRA DEVICE (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS, IMPLANTED WITH A CONTEGRA, ADVERSE EVENTS INCLUDED: INCREASED GRADIENT MEASUREMENTS, ENDOCARDITIS AND HEMODYNAMIC RELEVANT DEGENERATION TREATED WITH VALVE EXPLANT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629366 VALVE CONTEGRA CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION CONTEGRA

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention