BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS VALVE SYSTEM

    MDR report key: 11816771 · Received May 13, 2021

    Report

    Report Number
    2134265-2021-05732
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    January 1, 2016
    Report Date
    May 12, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT - APPROXIMATE. EVENTS OCCURRED AFTER JANUARY 2016. LITERATURE CITATION:HOKKEN TW, VAN WIECHEN MP, OOMS JF, EL AZZOUZI I, DE RONDE M, KARDYS I, BUDDE R, DAEMEN J, DE JAEGERE PP, VAN MIEGHEM NM. IMPACT OF INTERVENTRICULAR MEMBRANOUS SEPTUM LENGTH ON PACEMAKER NEED WITH DIFFERENT TRANSCATHETER AORTIC VALVE IMPLANTATION SYSTEMS. INT J CARDIOL. 2021: RETRIEVED FROM HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/33675890.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ARTICLE COMPLETE HEART BLOCK (CHB) AND ARRHYTHMIA OCCURRED THIS RETROSPECTIVE, CASE-CONTROL STUDY ENROLLED ALL PATIENTS WHO UNDERWENT A SUCCESSFUL TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PROCEDURE WITH CONTEMPORARY TRANSCATHETER HEART VALVE (THV) PLATFORMS I.E. NON-BOSTON SCIENTIFIC (BSC) VALVE SYSTEMS, LOTUS VALVE SYSTEM OR ACURATE VALVE SYSTEM IN THE ERASMUS UNIVERSITY MEDICAL CENTER BETWEEN JANUARY 2016 AND MARCH 2020. THE FOLLOW-UP PERIOD FOR NEW PERMANENT PACEMAKER IMPLANTATION (PPI) WAS 30DAYS. MEMBRANOUS SEPTUM (MS) LENGTH WAS DETERMINED BY COMPUTED TOMOGRAPHY (CT). LITERATURE STUDY RESULTS: THE STUDY CONSISTED 653 TAVI PATIENTS WITH MEDIAN AGE 80.6YEARS. NEW PPI OCCURRED IN 120 PATIENTS (18.4%). PATIENTS WITH NEW PPI HAD A SHORTER MS LENGTH 2.9MM VS. 4.2MM . MS LENGTH<3MM IDENTIFIED A HIGH-RISK PHENOTYPE WITH 30.3% PPI-RATE, MS LENGTH 3-6MM AN INTERMEDIATE-RISK PHENOTYPE WITH 15.4% PPI-RATE AND MS LENGTH >6MM A LOW-RISK PHENOTYPE WITH A 6.3% PPI-RATE. FOR THE LOTUS VALVE, THERE WAS NO SIGNIFICANT DIFFERENCE IN PPI-RATES BETWEEN THE HIGH-RISK (45.8%, OR 3.5 [95%CI 0.8-15.1]) AND LOW-RISK GROUP (20%). BY MULTIVARIATE ANALYSIS MS LENGTH, AGATSTON-SCORE, USE OF LOTUS VALVE, AND ELECTROCARDIOGRAPH (ECG) WITH FIRST-DEGREE ATRIOVENTRICULAR (AV) BLOCK, RIGHT BUNDLE BRANCH BLOCK (RBBB) OR BIFASCULAR BLOCK WERE INDEPENDENT PREDICTORS FOR NEW PPI. LITERATURE STUDY CONCLUSION: MS LENGTH WAS AN INDEPENDENT PREDICTOR FOR NEW PPI POST-TAVI. THREE PHENOTYPES WERE FOUND BASED ON MS LENGTH. MS LENGTH <3MM WAS UNIVERSALLY ASSOCIATED WITH A HIGH RISK FOR NEW PPI (>30%). MS LENGTH >6MM REPRESENTED A LOW-RISK PHENOTYPE WITH PPI RATE<10%. PPI RATE VARIED PER THV TYPE IN THE INTERMEDIATE PHENOTYPE. PPI RATE WITH LOTUS VALVE WAS HIGH REGARDLESS OF MS LENGTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717693 LOTUS VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention