BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM TISSUE HEART VALVE (UNKNOWN)

    MDR report key: 11220821 · Received January 24, 2021

    Report

    Report Number
    3001883144-2021-00010
    Event Type
    Injury
    Date Received
    January 24, 2021
    Report Date
    January 24, 2021
    Manufacturer
    ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA)
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED IN A RESEARCH ARTICLE, COMPLICATIONS FROM TRANSCATHETER VALVE REPLACEMENT OF A TISSUE VALVE INCLUDED BLEEDING, PACEMAKER IMPLANT, ATRIAL FIBRILLATION, RENAL FAILURE, PARAVALVULAR LEAK, CORONARY OBSTRUCTION, HOSPITALIZATION, AND VALVE REPLACEMENT. 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.

    Description of Event or Problem · 1

    RELATED MANUFACTURING REFERENCE NUMBER: 3008452825-2021-00029. THE ARTICLE, "TRANSCATHETER AND MINISTERNOTOMY AORTIC VALVE REPLACEMENT AFTER BIOPROSTHETIC VALVE FAILURE" WAS REVIEWED. THE RESEARCH ARTICLE IS A RETROSPECTIVE SINGLE CENTER EXPERIENCE TO REPORT PATIENT'S UNDERGOING TRANSCATHETER VALVE-IN-VALVE IMPLANTATION (TVIV) AND MINIMALLY INVASIVE RE-OPERATIVE AORTIC VALVE REPLACEMENT (MIRAVR) AFTER BIOPROSTHETIC VALVE FAILURE. EPIC, BIOCOR, TRIFECTA AND MECHANICAL VALVE (ABBOTT), SAPIEN, SAPIEN XT, SAPIEN 3, CARPENTIER EDWARDS PERIMOUNT (EDWARDS LIFESCIENCES), COREVALVE, EVOLUT R, AND EVOLUT PRO(MEDTRONIC) AND SORIN VALVES WERE ASSOCIATED WITH THE STUDY. THERE IS NO ALLEGATION OF MALFUNCTION OF THE ABBOTT DEVICE. THE ARTICLE CONCLUDED THAT DESPITE BEING AT HIGHER-RISK, PATIENTS UNDERGOING TVIV HAD REDUCED RATES OF PERMANENT PACEMAKER IMPLANTATIONS AND ATRIAL FIBRILLATION, AND A SHORTER HOSPITAL STAY AS COMPARED TO MIRAVR. THE PRIMARY AUTHOR AND CORRESPONDING AUTHOR IS VISHAL N. SHAH DO, LANKENAU INSTITUTE FOR MEDICAL RESEARCH, WYNNEWOOD, PENNSYLVANIA, USA WITH THE EMAIL [email protected].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117268 SJM TISSUE HEART VALVE (UNKNOWN) HEART-VALVE, NON-ALLOGRAFT TISSUE LWR ST. JUDE MEDICAL, BRASIL LTDA. (PAMPULHA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention