BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM TISSUE HEART VALVE (UNKNOWN)

    MDR report key: 11735319 · Received April 27, 2021

    Report

    Report Number
    3001883144-2021-00052
    Event Type
    Injury
    Date Received
    April 27, 2021
    Report Date
    May 17, 2021
    Manufacturer
    ST. JUDE MEDICAL, BRASIL LTDA
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN A RESEARCH ARTICLE, PERIPROCEDURAL STROKE, MAJOR BLEEDING, IMPLANTATION OF PERMANENT PACEMAKER, ENDOCARDITIS, STRUCTURAL FAILURE, AORTIC STENOSIS, AORTIC REGURGITATION AND RE-OPERATION WAS FOUND IN RECIPIENTS OF PROSTHETIC HEART VALVES. 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: 2648612-2021-00043. THE ARTICLE, "PROPENSITY MATCHED LONG-TERM ANALYSIS OF MECHANICAL VERSUS STENTLESS AORTIC VALVE REPLACEMENT IN THE YOUNGER PATIENT", WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE MULTI CENTER EXPERIENCE TO COMPARE THE LONG-TERM OUTCOMES TO MECHANICAL PROSTHESES IN YOUNGER PATIENTS (AGE <_60 YEARS). EDWARDS PRIMA PLUS PROSTHESES (EDWARDS LIFESCIENCE),TORONTO PROSTHESES (ABBOTT) , FREESTYLE PROSTHESES (MEDTRONIC), ELAN PROSTHESES (VASCUTEK), CARBOMEDICS STANDARD PROSTHESES (CARBOMEDICS INC), SJM MECHANICAL PROSTHESIS(ABBOTT), MEDTRONIC OPEN PIVOT PROSTHESES (MEDTRONIC), ON-X PROSTHESES (MEDICAL CARBON RESEARCH INSTITUTE), ULTRACOR PROSTHESES (AORTECH EUROPE LTD) AND SORIN PROSTHESES (SORIN GROUP) WERE ASSOCIATED WITH THE STUDY. THERE IS NO ALLEGATION OF MALFUNCTION OF THE ABBOTT DEVICES. TORONTO PROSTHESES (ABBOTT) ARE NO LONGER BEING MANUFACTURED, THUS THIS REPORT IS CONSERVATIVELY BEING REPORTED. THE PRIMARY AND CORRESPONDENCE AUTHOR OF THE ARTICLE IS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626800 SJM TISSUE HEART VALVE (UNKNOWN) HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, BRASIL LTDA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention