BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS VALVE SYSTEM

    MDR report key: 11819194 · Received May 13, 2021

    Report

    Report Number
    2134265-2021-05920
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    September 1, 2018
    Report Date
    May 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT APPROXIMATE. EVENTS OCCURRED PRIOR TO (B)(6) 2018. LITERATURE CITATION: GIORDANO A, BIONDI-ZOCCAI G, CORCIONE N, FERRARO P, BEDOGNI F, TESTA L, SARDELLA G, MANCONE M, TOMAI F, DE PERSIO G, IADANZA A, PIERLI C, FRATI G. TCT-44 COMPARATIVE EFFECTIVENESS AND SAFETY OF FIVE LEADING NEW-GENERATION TAVI DEVICES: 12-MONTH RESULTS FROM THE RISPEVA STUDY [MEETING ABSTRACT]. J AM COLL CARDIOL. 2018; 72 (13 SUPPLEMENT): B19-B20.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE ABSTRACT TITLED "COMPARATIVE EFFECTIVENESS AND SAFETY OF FIVE LEADING NEW-GENERATION TAVI DEVICES: 12-MONTH RESULTS FROM THE RISPEVA STUDY: THAT PATIENT COMPLICATIONS OCCURRED. A TOTAL OF 1409 PATIENTS WERE INCLUDED: 88 (6.2%) OF THE PATIENTS WERE TREATED WITH ACURATE NEO VALVE SYSTEM, 91 (6.5%) OF THE PATIENTS WERE TREATED WITH THE LOTUS VALVE SYSTEM, AND 1327 (87.3%) WITH NON-BOSTON SCIENTIFIC (BSC) VALVE SYSTEMS. SEVERAL BASELINE AND PROCEDURAL DIFFERENCES WERE EVIDENT AT UNADJUSTED ANALYSIS. NONETHELESS, DEVICE SUCCESS AND PROCEDURAL SUCCESS RATES WERE ALL ABOVE 96%. IN-HOSPITAL EVENT RATES WERE SIMILAR, WITH DEATH RATES ALL BELOW 4%, DESPITE A SIGNIFICANT DIFFERENCE IN THE RATE OF PERMANENT PACEMAKER IMPLANTATION (WITH HIGHER RATES FOR LOTUS VALVE AND NON-BSC VALVE SYSTEMS). UNADJUSTED ANALYSIS OF 12-MONTH OUTCOMES SHOWED SIGNIFICANT DIFFERENCES FOR MAJOR ADVERSE EVENTS (MAE) FAVORING ACURATE NEO VALVE SYSTEM AND NON-BSC VALVE SYSTEMS, MAJOR VASCULAR COMPLICATION FAVORING ACURATE NEO VALVE SYSTEM AND NON-BSC VALVE SYSTEMS, PACEMAKER IMPLANTATION FAVORING ACURATE NEO VALVE SYSTEMS, AND AORTIC REGURGITATION FAVORING LOTUS VALVE SYSTEMS. PROPENSITY-MATCHED ANALYSIS CONFIRMED THAT THE LOWEST RISK OF MAE WAS ASSOCIATED WITH ACURATE NEO VALVE SYSTEM AND NON-BSC VALVE SYSTEM, THE LOWEST RISK OF MAJOR VASCULAR COMPLICATION WITH NON-BSC VALVE SYSTEM, THE LOWEST RISK OF PACEMAKER IMPLANTATION WITH ACURATE NEO VALVE SYSTEM, AND THE LOWEST RISK OF AORTIC REGURGITATION WITH LOTUS VALVE SYSTEM. WITH THE LIMITED INFORMATION AVAILABLE, IT WAS NOT POSSIBLE TO DETERMINE WHAT SPECIFIC INCIDENTS OCCURRED WITH THE ACURATE NEO VALVE OR THE LOTUS VALVE. THIS REPORT IS BEING SUBMITTED AS THE ARTICLE IDENTIFIES THE ACURATE NEO VALVE AND THE LOTUS VALVE DEVICE WAS IMPLANTED IN SOME OF THE PATIENTS BEING TREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712813 LOTUS VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other