BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTEGRA

    MDR report key: 4782425 · Received May 19, 2015

    Report

    Report Number
    2025587-2015-00567
    Event Type
    Injury
    Date Received
    May 19, 2015
    Date of Event
    April 25, 2015
    Report Date
    June 12, 2015
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    MWH
    PMA / PMN Number
    H020003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES WERE NOT RETURNED TO MEDTRONIC. (B)(4). TITLE: LATE INCIDENCE OF ENDOCARDITIS AND CONDUIT FAILURE IN PATIENTS UNDERGOING PLACEMENT OF RIGHT VENTRICULAR TO PULMONARY ARTERIAL CONDUITS WITH BOVINE JUGULAR GRAFTS AUTHORS: CARLOS M MERY, FRANCISCO GUZMANPRUNEDA, MATTHEW D TERWELP, LUIS E DELEON, IKI ADACHI, JEFFREY S HEINLE, E. DEAN MCKENZIE, JOURNAL CITATION: PRESENTED AT AMERICAN ASSOCIATION FOR THORACIC SURGERY (AATS) CONFERENCE, APRIL 25-29, 2015 IN SEATTLE, WASHINGTON. ABSTRACT AVAILABLE; FULL BODY ARTICLE WAS NOT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    REQUESTS FOR ADDITIONAL INFORMATION PROVIDED NO FURTHER DETAILS. CONCLUSION: NO DEVICES WERE RETURNED, AND NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. WITHOUT THIS INFORMATION A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AND ROOT CAUSE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT A RETROSPECTIVE STUDY WAS PERFORMED TO EVALUATE LONG-TERM RESULTS OF BOVINE JUGULAR GRAFTS AS PULMONARY ARTERIAL CONDUITS IN TERMS OF ENDOCARDITIS AND FAILURE RISK. THE RESULTS WERE PRESENTED AS PART OF A MEDICAL CONFERENCE. THE STUDY INCLUDED 245 PULMONARY ARTERIAL CONDUITS IMPLANTED IN 223 PATIENTS (PREDOMINANTLY FEMALE) IN ONE INSTITUTION BETWEEN 2001 AND 2014. OF THE 223 PATIENTS, 163 WERE FIVE YEARS OLD OR YOUNGER. THE AVERAGE CONDUIT SIZE IMPLANTED WAS 16 MM. ACROSS ALL PATIENTS, ENDOCARDITIS COMPLICATED 14 OF THE CONDUITS WITH A MEDIAN TIME TO EVENT OF SEVEN YEARS (RANGE: 34 DAYS TO 10 YEARS). OF THE 14 CASES, 12 WERE REPLACED AND 2 WERE MANAGED MEDICALLY. THE ABSTRACT DID NOT INDICATE MEDTRONIC PRODUCTS WERE USED IN THIS STUDY; HOWEVER, INFORMATION OBTAINED FROM A PHYSICIAN AT THE IMPLANTING FACILITY (WHO WAS NOT A LISTED AUTHOR) INDICATED THAT THE TYPES OF DEVICES INCLUDED IN THIS STUDY WERE PORCINE HETEROGRAFTS, AORTIC AND PULMONARY HOMOGRAFTS, AND MEDTRONIC PULMONARY CONDUITS. ADDITIONAL DETAILS REGARDING THE MEDTRONIC PRODUCTS, INCLUDING THE TOTAL NUMBER IMPLANTED OR ASSOCIATED WITH AN ADVERSE EVENT, WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325148 CONTEGRA CONDUIT,VALVED,PULMONIC MWH MEDTRONIC HEART VALVES DIVISION PVC216

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R