BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM MECHANICAL HEART VALVE

    MDR report key: 11699841 · Received April 21, 2021

    Report

    Report Number
    2648612-2021-00044
    Event Type
    Death
    Date Received
    April 21, 2021
    Report Date
    June 14, 2021
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, 4,478 PATIENTS UNDERWENT AORTIC VALVE REPLACEMENT WITH CONCOMITANT CORONARY ARTERY BYPASS GRAFT BETWEEN (B)(6) 2002 AND (B)(6) 2018. 1,952 OF THOSE PATIENTS WERE IMPLANTED WITH A MECHANICAL PROSTHETIC AORTIC VALVE AND 533 PATIENTS WERE IMPLANTED WITH A BIOPROSTHETIC AORTIC VALVE. SJM MECHANICAL PROSTHETIC VALVES (ABBOTT), ATS MEDICAL, AND HANCOCK II (MEDTRONIC) WERE ASSOCIATED WITH THE STUDY. AN EVENT A 1.5% 30-DAY MORTALITY WAS REPORTED. A MORE COMPREHENSIVE ASSESSMENT COULD NOT BE PERFORMED AS THE EVENT WAS NON-CONTEMPORANEOUSLY REPORTED THROUGH A LITERATURE REVIEW AND NO DEVICE WAS RECEIVED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    THE RESULTS/METHOD AND CONCLUSION CODES ALONG WITH INVESTIGATION RESULTS WILL BE PROVIDED IN THE FINAL REPORT.

    Description of Event or Problem · 1

    RELATED MANUFACTURING REFERENCE NUMBER: 2648612-2021-00040. THE ARTICLE, "PROSTHESIS SELECTION FOR AORTIC VALVE REPLACEMENT WITH CONCOMITANT CORONARY ARTERY BYPASS GRAFT", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTI CENTER EXPERIENCE TO INVESTIGATE POSTOPERATIVE OUTCOMES IN PATIENTS WITH A BIOPROSTHETIC OR MECHANICAL PROSTHESIS. SJM MECHANICAL PROSTHETIC VALVES (ABBOTT), ATS MEDICAL AND HANCOCK II(MEDTRONIC) WERE ASSOCIATED WITH THE STUDY. THERE IS NO ALLEGATION OF MALFUNCTION OF THE ABBOTT DEVICE. THE ARTICLE CONCLUDED THAT LONG-TERM SURVIVAL, OVERALL REOPERATION, OR STROKE INCIDENCE WAS COMPARABLE AMONG THE TWO GROUPS, WHILE PATIENTS WITH A MECHANICAL VALVE SHOWED A GREATER LIKELIHOOD OF MAJOR BLEEDING EVENTS. THE PRIMARY AUTHOR OF THE ARTICLE IS XINGJIAN HU, DEPARTMENT OF CARDIOVASCULAR SURGERY, UNION HOSPITAL, TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY, WUHAN, CHINA. THE CORRESPONDING AUTHOR OF THE ARTICLE IS YIN WANG, M.D., PH.D. , DEPARTMENT OF CARDIOVASCULAR SURGERY, UNION HOSPITAL, TONGJI MEDICAL COLLEGE, HUAZHONG UNIVERSITY OF SCIENCE AND TECHNOLOGY JIEFANG AVENUE 1277#, WUHAN, HUBEI, 430000, CHINA WITH THE CORRESPONDING EMAIL: [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599811 SJM MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ST. JUDE MEDICAL PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death