BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM MASTERS SERIES MECHANICAL HEART VALVE

    MDR report key: 12502623 · Received September 20, 2021

    Report

    Report Number
    2648612-2021-00095
    Event Type
    Injury
    Date Received
    September 20, 2021
    Date of Event
    August 23, 2021
    Report Date
    September 27, 2021
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION FOR: G3, G6, H2, H6, AND H10. AS REPORTED IN A RESEARCH ARTICLE, 144 PATIENTS UNDERWENT AORTIC VALVE REPLACEMENT (AVR) FROM JANUARY 2017 TO DECEMBER 2020; SJM MASTERS SERIES MECHANICAL HEART VALVE (ABBOTT) AND CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE (EDWARDS LIFESCIENCES) WERE ASSOCIATED WITH THE STUDY. EVENTS OF RE-OPERATION DUE TO BLEEDING, RENAL FAILURE, PERMANENT STROKE, AND PROLONGED MECHANICAL VENTILATION WERE 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

    THE ARTICLE, "AORTIC PROSTHETIC SIZE PREDICTOR IN AORTIC VALVE REPLACEMENT" WAS REVIEWED. THIS RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO COMPARE PREOPERATIVE MEASUREMENTS OF AORTIC ANNULUS FROM ECHOCARDIOGRAPHY AND COMPUTED TOMOGRAPHY (CT) SCAN WITH SURGICAL SIZING AND DEVELOP AN IMAGING-BASED ALGORITHM TO PREDICT PATIENT-PROSTHESIS MISMATCH (PPM). SJM MASTERS SERIES MECHANICAL HEART VALVE (ABBOTT) AND CARPENTIER-EDWARDS PERIMOUNT MAGNA EASE (EDWARDS LIFESCIENCES) WERE ASSOCIATED WITH THE STUDY. THE ARTICLE CONCLUDED THAT PREOPERATIVE CT SCAN MEASUREMENTS ARE A RELIABLE PREDICTOR OF AORTIC PROSTHESIS SIZE. TRANSTHORACIC ECHOCARDIOGRAPHY IS A POSSIBLE ALTERNATIVE, THOUGH IT IS HIGHLY PERFORMER-DEPENDENT AND UNABLE TO REPRESENT THE AORTIC ANNULUS FULLY. TOGETHER, THESE TWO IMAGING MODALITIES CAN BE USED TO QUANTITATIVELY ANTICIPATE PPM PREOPERATIVELY. THE PRIMARY AUTHOR OF THE ARTICLE IS ANH TUAN VO, DEPARTMENT OF CARDIOVASCULAR SURGERY, UNIVERSITY MEDICAL CENTER, UNIVERSITY OF MEDICINE AND PHARMACY AT HO CHI MINH CITY, 215 HONG BANG STREET, DISTRICT 5, HO CHI MINH CITY, VIETNAM. THE CORRESPONDENCE AUTHOR OF THE ARTICLE IS DINH HOANG NGUYEN,DEPARTMENT OF CARDIOVASCULAR SURGERY, UNIVERSITY MEDICAL CENTER, UNIVERSITY OF MEDICINE AND PHARMACY AT HO CHI MINH CITY, 215 HONG BANG STREET, DISTRICT 5, HO CHI MINH CITY, VIETNAM WITH THE CORRESPONDING EMAIL: [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1396762 SJM MASTERS SERIES MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ST. JUDE MEDICAL PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention| S