BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE CONTEGRA

    MDR report key: 5873525 · Received August 12, 2016

    Report

    Report Number
    2025587-2016-01238
    Event Type
    Injury
    Date Received
    August 12, 2016
    Date of Event
    March 15, 2014
    Report Date
    July 15, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: YONG M. LONG-TERM OUTCOMES OF PATIENTS WITH ABSENT PULMONARY VALVE SYNDROME: 38 YEARS OF EXPERIENCE. ANN THORAC SURG 2014; 97:1671¿7. 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. (B)(4).

    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 REVIEW REGARDING LONG-TERM OUTCOMES OF ABSENT PULMONARY VALVE SYNDROME. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN 1975 AND 2013. THE STUDY POPULATION INCLUDED 52 PATIENTS (PREDOMINANTLY FEMALE; MEAN AGE 9 MONTHS, MEAN WEIGHT 6.9 KG), 3 OF WHICH RECEIVED MEDTRONIC HANCOCK VALVED CONDUIT AND 6 OF WHICH RECEIVED MEDTRONIC CONTEGRA VALVED CONDUIT. NO SERIAL NUMBERS WERE PROVIDED. AMONG ALL PATIENTS 10 DEATHS OCCURRED (7 EARLY, 3 LATE). THE EARLY DEATHS WERE DUE TO SUDDEN DEATH AFTER CARDIAC ARREST (2) AND FOLLOWING WITHDRAWAL OF PROLONGED VENTILATION FOR PERSISTENT AIRWAY OBSTRUCTION (5). THE LATE DEATHS WERE DUE TO: PNEUMOCOCCAL SEPSIS (1), FAILURE TO WEAN OFF CARDIOPULMONARY BYPASS AFTER A RESIDUAL VENTRICULAR SEPTAL DEFECT CLOSURE (1), AND AN UNKNOWN CAUSE (1). THE ARTICLE DOES NOT INDICATE A DIRECT RELATIONSHIP BETWEEN THE VALVE IMPLANT/FUNCTION AND THE DEATHS. THERE WAS NO ALLEGATION AGAINST THE VALVE OR ITS FUNCTION NOR WAS THERE ANY ALLEGATION THAT THE VALVE CONTRIBUTED TO THE PATIENT DEATHS. AMONG ALL PATIENTS OTHER ADVERSE EVENTS INCLUDED: PLEURAL EFFUSION REQUIRING DRAINAGE (2), PERICARDIAL EFFUSIONS REQUIRING DRAINAGE (4), COMPLETE HEART BLOCK REQUIRING A PERMANENT PACEMAKER (3), PULMONARY REGURGITATION AT DISCHARGE (27 MODERATE/SEVER, 20 TRIVIAL/MILD ), RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) OBSTRUCTION (26 TRIVIAL, 22 MILD, 1 MODERATE), AND REOPERATION (4). MULTIPLE MANUFACTURERS WERE NOTED IN THE LITERATURE; BASED ON THE AVAILABLE INFORMATION A DIRECT CORRELATION COULD NOT BE MADE BETWEEN THE OBSERVED ADVERSE EVENTS AND MEDTRONIC PRODUCT. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524557 VALVE CONTEGRA CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION CONTEGRA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Required Intervention