BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VALVE CONDUIT CONTEGRA

    MDR report key: 4201587 · Received October 27, 2014

    Report

    Report Number
    2025587-2014-00792
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    July 11, 2006
    Report Date
    September 29, 2014
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE PRODUCTS IN THE ARTICLE WERE UNSUCCESSFUL. THE SITE NOTED THAT THEY WERE NOT ABLE TO OBTAIN SPECIFIC DEVICES WITH THE REPORTED EVENTS. WITHOUT THE RETURN OF THE PRODUCT(S), NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION(S). (B)(4).

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A RETROSPECTIVE STUDY IN THE ANNALS OF THORACIC SURGERY; 2006; 82:2221¿ 6, THAT SUMMARIZED THE 20-YEAR EXPERIENCE OF SURGICAL TREATMENT IN PATIENTS WITH ABSENT PULMONARY VALVE SYNDROME (APVS). BETWEEN 1984 AND 2005, 20 PATIENTS UNDERWENT REPAIR OF APVS USING A VALVED CONDUIT (N=9; MEDTRONIC JUGULAR VEIN VALVED CONTEGRA CONDUIT (N=2)), TRANSANNULAR PATCH (TAP) INSERTION ALONE (N=5), OR TAP WITH MONOCUSP VALVE (N=6) WITH PA REDUCTION ARTERIOPLASTY. THE MEDIAN AGE WAS 7 MONTHS (RANGE, 6 DAYS TO 9 YEARS); 50% MALE. THE SIZE OF CONDUIT VARIED FROM 10 TO 26 MM (MEAN, 14.6 PLUS OR MINUS 4.7 MM). THERE WAS ONE PERIOPERATIVE AND TWO LATE (MORE THAN 30 DAYS POST-OPERATIVE) DEATHS, ALL RELATED TO AIRWAY COMPLICATIONS IN PATIENTS LESS THAN 40 DAYS OLD AT THE TIME OF SURGERY. THE PERIOPERATIVE DEATH OCCURRED DESPITE EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SUPPORT FOR LOW CARDIAC OUTPUT. THE FIRST LATE DEATH OCCURRED 2 MONTHS POST-OPERATIVE DUE TO ASPIRATION AND PNEUMONIA. THE SECOND LATE DEATH OCCURRED 3 MONTHS POST-OPERATIVE DUE TO BRONCHOPNEUMONIA AND SEPSIS. SIX PATIENTS (33%) UNDERWENT REOPERATION FOR PULMONARY VALVE INCOMPETENCE AND RIGHT VENTRICULAR DYSFUNCTION. THE MEAN INTERVAL BETWEEN INITIAL PROCEDURE AND REOPERATION WAS 5.5 PLUS OR MINUS 2.7 YEARS (RANGE, 2 TO 9 YEARS). THE INDICATIONS FOR THE REOPERATION WAS RIGHT VENTRICULAR TO PULMONARY ARTERY (RV-PA) CONDUIT INSUFFICIENCY OR STENOSIS (N=4), AND POLYTETRAFLUOROETHYLENE (PTFE) MONOCUSP INSUFFICIENCY (N=2). THE SYSTOLIC RV-PA CONDUIT GRADIENT RANGED FROM 35 TO 80 (MEAN, 57-22 MMHG). IT IS UNKNOWN IF A MEDTRONIC PRODUCT IS RELATED TO THE NEED FOR REOPERATION. ALL PATIENTS IN THE STUDY WERE DE-IDENTIFIED SO NO SERIAL NUMBERS WERE ABLE TO BE OBTAINED. CITATION: TITLE: SURGICAL TREATMENT OF ABSENT PULMONARY VALVE SYNDROME ASSOCIATED WITH BRONCHIAL OBSTRUCTION JOURNAL: ANN THORAC SURG YEAR: 2006 ISSUE: 2006;82:2221¿ 6 LITERATURE REFERENCE NUMBER: DOI:10.1016/J.ATHORACSUR.2006.07.022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684539 VALVE CONDUIT CONTEGRA CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION PVC212

    Patients

    Seq Age Sex Outcome Treatment
    1 00007 MO Required Intervention