BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE CONTEGRA

    MDR report key: 4696000 · Received April 15, 2015

    Report

    Report Number
    2025587-2015-00428
    Event Type
    Injury
    Date Received
    April 15, 2015
    Date of Event
    July 17, 2014
    Report Date
    May 22, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    DYE
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE WAS RETURNED, AND NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. WITHOUT THIS INFORMATION A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT RETURNED TO MEDTRONIC. (B)(4). TITLE: MR AND CT IMAGING OF PULMONARY VALVED CONDUITS IN CHILDREN AND ADOLESCENTS: NORMAL APPEARANCE AND COMPLICATIONS AUTHORS: ESTELLE V. TENISCH, LEONOR T. ALAMO, NICOLE SEKARSKI, MICHEL HURNI <(>&<)> FRANÇOIS GUDINCHET DOI 10.1007/S00247-014-3057-2.

    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 THAT A RETROSPECTIVE STUDY WAS PERFORMED TO DESCRIBE BOTH NORMAL AND PATHOLOGICAL APPEARANCES OF IMPLANTED PULMONARY VALVED CONDUIT IN POSTOPERATIVE FOLLOW-UP. THE STUDY EVALUATED COMPUTED TOMOGRAPHY (CT) AND MAGNETIC RESONANCE IMAGING (MRI) FOLLOW-UP DATA COLLECTED BETWEEN JANUARY 1999 AND JULY 2013 FOR 24 PATIENTS (PREDOMINANTLY MALE; MEAN AGE OF 11 YEARS) IMPLANTED WITH PULMONARY VALVED CONDUIT (MODEL/SERIAL NOT PROVIDED). PER TABLES 4 AND 5 WITHIN THE LITERATURE, OBSERVED COMPLICATIONS CONFIRMED BY CT OR MRI ANALYSIS INCLUDED STENOSIS (N= 15), CALCIFICATION (N=11), DILATATION (N=8), PLICATURE/TWIST (N=6), VALVULAR REGURGITATION (N=5), AND THROMBUS/VEGETATION (N=2). PER TABLE 1 WITHIN THE LITERATURE, COMPLICATIONS LISTED AS INDICATIONS FOR RADIOLOGICAL EXAMINATION INCLUDED ENDOCARDITIS (N=3), PULMONARY EMBOLISM (N=3), PULMONARY EDEMA (N=1), HEMOTHORAX (N=1), MEDIASTINITIS (N=1), PNEUMONIA (N=1), DYSPNEA (N=1), RETROSTERNAL CHEST PAIN (N=1), AND PULMONARY HYPERTENSION (N=1). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. REQUESTS FOR ADDITIONAL INFORMATION PROVIDED NO FURTHER DETAILS.

    Description of Event or Problem · 1

    ALSO, SEVEN TOTAL PATIENTS UNDERWENT INTERVENTION: IMPLANTATION OF A NEW VALVE (N=5) OR STENT (N=1) IN THE PULMONARY VALVED CONDUIT OR THE PULMONARY ARTERY (N=1). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250609 VALVE CONTEGRA DYE MEDTRONIC HEART VALVES DIVISION CONTEGRA

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR Congenital Anomaly| L| R