BEUDAMED
    FDA Adverse Event Death Summary report: N

    VALVE CONDUIT CONTEGRA

    MDR report key: 4241702 · Received November 10, 2014

    Report

    Report Number
    2025587-2014-00872
    Event Type
    Death
    Date Received
    November 10, 2014
    Date of Event
    January 1, 2007
    Report Date
    December 3, 2014
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDTRONIC'S ATTEMPT TO OBTAIN ADDITIONAL INFORMATION ON THE PATIENTS AND DEVICES IN THIS STUDY WAS UNSUCCESSFUL. WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION. CITATION: OZKAN, S., AKAY, T.H., GULTEKIN, B., SEZGIN, A., TOKEL, K., ASLAMACI, S. XENOGRAFT TRANSPLANTATION IN CONGENITAL CARDIAC SURGERY AT BASKENT UNIVERSITY: MIDTERM RESULTS. (B)(4)

    Additional Manufacturer Narrative · 1

    CONDUIT STENOSIS IS THE MAJOR RISK FACTOR FOR REOPERATION. IN THESE PATIENTS, REOPERATION FOR CONDUIT REPLACEMENT CAN BE PERFORMED SAFELY BEFORE DETERIORATION OF CARDIAC PERFORMANCE. BASED ON THE CONTENT OF THE ARTICLE, THERE WAS NO SPECIFIC INFORMATION IF THE REPORTED DEATHS WERE RELATED TO THE CONTEGRA DEVICE. A DEVICE HISTORY RECORDS REVIEW COULD NOT BE PERFORMED AS THE SERIAL NUMBERS WERE NOT PROVIDED. BASED ON THE LIMITED INFORMATION RECEIVED, A ROOT CAUSE CANNOT BE DETERMINED. MEDTRONIC WILL CONTINUE TO MONITOR FIELD PERFORMANCE FOR SIMILAR EVENTS SHOULD THEY OCCUR.

    Additional Manufacturer Narrative · 1

    NO EVAL EXPLAIN CODE. 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 FROM THE JOURNAL OF TRANSPLANTATION PROCEEDINGS ENTITLED ¿XENOGRAFT TRANSPLANTATION IN CONGENITAL CARDIAC SURGERY AT BASKENT UNIVERSITY: MIDTERM RESULTS.¿ IN THE STUDY THEY HAVE PRESENTED MIDTERM RESULTS OF PEDIATRIC PATIENT¿S PATHOLOGIES THAT WERE OPERATED ON WITH XENOGRAFT CONDUITS BETWEEN JANUARY 1999 AND JANUARY 2005. THESE CONDUITS WERE USED TO ESTABLISH THE CONTINUITY OF THE RIGHT VENTRICLE TO THE PULMONARY ARTERY OR THE AORTA, THE LEFT VENTRICLE TO PULMONARY ARTERY, AND THE AORTA DUE TO VARIOUS TYPES OF COMPLEX CARDIAC ANOMALIES. THESE GRAFTS WERE OBTAINED FROM CONTEGRA BOVINE JUGULAR VEIN CONDUIT (20 PATIENTS), AND OTHER NON-MEDTRONIC SOURCES (114 PATIENTS). PATIENTS WERE FOLLOWED BY TRANSTHORACIC ECHOCARDIOGRAPHY (ECHO) PERIODICALLY AT 6-MONTH INTERVALS AFTER DISCHARGE BY THE REFERRING CARDIOLOGIST. OF THE 20 PATIENTS IN NEED OF REOPERATION DUE TO CONDUIT FAILURE, NONE WERE NOTED TO BE CONTEGRA CONDUITS. HOSPITAL MORTALITY WAS SEEN IN 28 PATIENTS AND 13 PATIENTS DIED DURING THE FOLLOW-UP PERIOD MEAN OF 24.6 MONTHS. SIX OF THE TWENTY CONTEGRA PATIENTS SUBSEQUENTLY EXPIRED. HOWEVER, THE CAUSES OF THE DEATHS WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723653 VALVE CONDUIT CONTEGRA CONDUIT,VALVED,PULMONIC MWH HEART VALVES SANTA ANA PVC212

    Patients

    Seq Age Sex Outcome Treatment
    1 Death