BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE CONTEGRA

    MDR report key: 6584690 · Received May 23, 2017

    Report

    Report Number
    2025587-2017-00846
    Event Type
    Injury
    Date Received
    May 23, 2017
    Date of Event
    January 1, 2005
    Report Date
    April 25, 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: BOETHIG D ET AL. MID TERM COURSE AFTER PEDIATRIC RIGHT VENTRICULAR OUTFLOW TRACT RECONSTRUCTION: A COMPARISON OF HOMOGRAFTS, PORCINE XENOGRAFTS AND CONTEGRAS. EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY. 2005; (27) 58¿66. DOI:10.1016/J.EJCTS.2004.09.009. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING EXPLANTS AND REOPERATION RATES BETWEEN DIFFERENT DEVICES USED TO RECONSTRUCT THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT). ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN APRIL 1991 AND JANUARY 2003. THE STUDY POPULATION INCLUDED 190 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 4.3 YEARS), 109 OF WHICH WERE IMPLANTED WITH A MEDTRONIC CONTEGRA CONDUIT (SERIAL NUMBERS WERE NOT PROVIDED). AMONG ALL CONTEGRA PATIENTS, THERE WAS AN OBSERVED HOSPITAL MORTALITY RATE OF 7.4% (BELOW THE EXPECTED RATE OF 10.2%). NONE OF THE DEATHS WERE ATTRIBUTED TO MEDTRONIC PRODUCT. AMONG ALL PATIENTS OBSERVED ADVERSE EVENTS INCLUDED: PULMONARY ARTERY STENOSIS, OSSIFICATION, CALCIFICATION, AND REOPERATIONS INCLUDING EXPLANT OF THE CONDUIT. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366157 VALVE CONTEGRA CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION CONTEGRA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 MO Required Intervention