BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS VALVE SYSTEM

    MDR report key: 11812948 · Received May 12, 2021

    Report

    Report Number
    2134265-2021-05743
    Event Type
    Injury
    Date Received
    May 12, 2021
    Date of Event
    August 1, 2007
    Report Date
    May 12, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT - APPROXIMATE. EVENT OCCURRED AFTER (B)(6) 2007. LITERATURE CITATION: MANUEL AM, ALMEIDA J, GUERREIRO C, DIAS T, BARBOSA A, TEIXEIRA P, RIBEIRO J, DIAS A, CAEIRO D, FONSECA M, TEIXEIRA M, OLIVEIRA M, GONCALVES H, PRIMO J, RODRIGUES A, GAMA V, BRAGA P, FONTES-CARVALHO R. THE EFFECTS OF TRANSCATHETER AORTIC VALVE IMPLANTATION ON CARDIAC ELECTRICAL PROPERTIES. REV PORT CARDIOL. 2020; 39 (8): 431-40.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ARTICLE THAT ARRHYTHMIA OCCURRED. EXTRACTED FROM LITERATURE ARTICLE: LITERATURE STUDY METHODS: A DETAILED RETROSPECTIVE ANALYSIS WAS PERFORMED OF ALL ELECTROCARDIOGRAPHS IN PATIENTS WHO UNDERWENT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI), BEFORE AND AFTER THE PROCEDURE, AT A TERTIARY CENTER FROM AUGUST 2007 TO OCTOBER 2016. PATIENTS WITH PERMANENT PACEMAKERS WERE EXCLUDED. A SEPARATE SUB ANALYSIS WAS PERFORMED ACCORDING TO THE TYPE OF IMPLANTED PROSTHESIS: SELF-EXPANDING PROSTHESES (SEP) OR BALLOON-EXPANDABLE PROSTHESIS (BEP). THE TYPES OF SEP INCLUDED NON-BOSTON SCIENTIFIC (BSC) VALVE SYSTEMS, ACURATE NEO VALVE SYSTEMS AND LOTUS VALVE SYSTEMS. THE BEP WERE NON-BSC VALVE SYSTEMS. LITERATURE STUDY RESULTS: 182 PATIENTS (78+/-8 YEARS; 56% FEMALE) WERE INCLUDED AND SEP WERE IMPLANTED IN 54% OF THE PATIENTS. MOST PATIENTS (80%) WERE IN SINUS RHYTHM AT BASELINE. AFTER TAVI, 21% OF PATIENTS DEVELOPED NEW-ONSET ATRIAL FIBRILLATION AND THERE WAS A SIGNIFICANT INCREASE IN PR INTERVAL AT DISCHARGE, WHICH WAS NOT MAINTAINED AFTER AT SIX-MONTH FOLLOW-UP. THERE WAS ALSO A SIGNIFICANT INCREASE IN QRS DURATION AT DISCHARGE, WHICH PERSISTED AT SIX-MONTHS. NEW-ONSET LEFT-BUNDLE BRANCH BLOCK (LBBB) WAS OBSERVED IN 25% OF PATIENTS. THE DEPTH OF VALVE IMPLANTATION WAS A PREDICTOR OF NEW LBBB AT DISCHARGE AFTER MULTIVARIATE ANALYSIS. LITERATURE STUDY CONCLUSION: THE MAIN ELECTROCARDIOGRAPHIC DISTURBANCES POST TAVI WERE PR PROLONGATION, INCREASED QRS AND NEW-ONSET LBBB. THESE DISTURBANCES WERE MORE PRONOUNCED IN PATIENTS UNDERGOING SEP IMPLANTATION AND TENDED TO IMPROVE AT SIX-MONTH FOLLOW-UP. THE DEPTH OF VALVE IMPLANTATION WAS A PREDICTOR OF CONDUCTION DISTURBANCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707990 LOTUS VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other