BEUDAMED
    FDA Adverse Event Death Summary report: N

    SJM MECHANICAL HEART VALVE

    MDR report key: 10988122 · Received December 10, 2020

    Report

    Report Number
    2648612-2020-00133
    Event Type
    Death
    Date Received
    December 10, 2020
    Report Date
    December 21, 2020
    Manufacturer
    ST. JUDE MEDICAL PUERTO RICO, INC.
    Product Code
    LWQ
    PMA / PMN Number
    P810002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED IN A RESEARCH ARTICLE, AFTER MECHANICAL HEART VALVE IMPLANT THREE PATIENTS DIED, TWO FROM SEPSIS AND ONE DUE TO BIVENTRICULAR FAILURE. 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: 2648612-2020-00132, 3001883144-2020-00117. THE ARTICLE, "BENCHMARKING OUTCOMES: REOPERATION FOR AORTIC VALVE PATIENT PROSTHESIS MISMATCH, ANNALS OF THORACIC SURGERY", WAS REVIEWED. THE RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO INVESTIGATE THE CLINICAL AND ECHOCARDIOGRAPHIC OUTCOMES OF PATIENTS WHO UNDERWENT RE-OPERATION FOR CORRECTION OF SYMPTOMATIC PATIENT PROSTHESIS MISMATCH(PPM) FOLLOWING PRIOR AORTIC VALVE REPLACEMENT. FREESTYLE MS VALVE (MEDTRONIC), REGENT MECHANICAL VALVES (ABBOTT), GELWEAVE VALSALVA PROSTHESIS WERE ASSOCIATED WITH THE STUDY. THERE IS NO ALLEGATION OF MALFUNCTION OF THE ABBOTT DEVICE. THE ARTICLE CONCLUDED THAT RE-OPERATIVE SURGERY FOR PPM IS COMPLEX, BUT MAY BE PERFORMED WITH GOOD OUTCOMES AND LOW MORTALITY IN EXPERIENCED CENTERS. THE PRIMARY AND CORRESPONDING AUTHOR OF THE ARTICLE IS BRENT KEELING, MD, DIVISION OF CARDIOTHORACIC SURGERY, EMORY UNIVERSITY ATLANTA, GA WITH THE EMAIL [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1447813 SJM MECHANICAL HEART VALVE HEART-VALVE, MECHANICAL LWQ ST. JUDE MEDICAL PUERTO RICO, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| H