BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS EDGE VALVE SYSTEM

    MDR report key: 11819461 · Received May 13, 2021

    Report

    Report Number
    2134265-2021-05664
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    April 1, 2019
    Report Date
    May 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    PMA / PMN Number
    P180029
    Removal / Correction Number
    92630745-FA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT APPROXIMATE. EVENTS OCCURRED (B)(6) 2019 OR LATER. LITERATURE CITATION: ARMARIO X, ROSSEEL L, KHARBANDA R, KHOGALI S, ABDEL-WAHAB M, VAN MIEGHEM NM, TCHETCHE D, DUMONTEIL N, DE BACKER O, COTTON J, MCGRATH B, BALAKRISHNAN D, ALI N, FARHAN S, JOSEPH J, CHARBONNIER G, OKUNO T, MCHUGH F, HILDICK-SMITH D, GILGEN N, HOKKEN T, SPENCE MS, FRERKER C, ANGELILLIS M, GRYGIER M, COCKBURN J, BJURSTEN H, JEGER RV, TELES R, PETRONIO AS, PILGRIM T, SINNING JM, NICKENIG G, SONDERGAARD L, BLACKMAN DJ, MYLOTTE D. TRANSCATHETER AORTIC VALVE REPLACEMENT WITH THE LOTUS EDGE SYSTEM: EARLY EUROPEAN EXPERIENCE. JACC CARDIOVASC INTERV. 2021; 14 (2): 172-81. RETRIEVED FROM HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/33478633.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT SERIOUS INJURIES OCCURRED. TITLE: TRANSCATHETER AORTIC VALVE REPLACEMENT WITH THE LOTUS EDGE SYSTEM: EARLY EUROPEAN EXPERIENCE. LITERATURE STUDY METHODS: BETWEEN APRIL AND NOVEMBER 2019, 286 CONSECUTIVE PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) WITH THE LOTUS EDGE VALVE SYSTEM AT 18 EUROPEAN CENTERS WERE INCLUDED IN A RETROSPECTIVE REGISTRY TO EVALUATE SHORT TERM CLINICAL OUTCOMES. THE MEAN AGE AND SOCIETY OF THORACIC SURGEONS SCORE WERE 81.2 +/ 6.9 YEARS AND 5.2 +/ 5.4%, RESPECTIVELY. NEARLY ONE HALF OF ALL PATIENTS WERE CONSIDERED TO HAVE COMPLEX ANATOMY. LITERATURE STUDY RESULTS: ADVERSE EVENTS INCLUDED THROMBOSIS, BLEEDING, ARRHYTHMIA AND RENAL IMPAIRMENT. AFTER TAVR, THE MEAN AORTIC VALVE AREA WAS 1.9 +/ 0.9 CM(2), AND THE MEAN TRANSVALVULAR GRADIENT WAS 11.9 +/ 5.7 MM HG. NONE OR TRACE PARAVALVULAR LEAK (PVL) OCCURRED IN 84.4% OF PATIENTS AND MODERATE PVL IN 2.0% OF PATIENTS. THERE WERE NO CASES OF SEVERE PVL. NEW PERMANENT PACEMAKER (PPM) IMPLANTATION WAS REQUIRED IN 25.9% AMONG ALL PATIENTS. NO CASES OF VALVE MALPOSITION WERE REPORTED. LITERATURE STUDY CONCLUSION: EARLY EXPERIENCE WITH THE LOTUS EDGE VALVE SYSTEM DEMONSTRATED SATISFACTORY SHORT TERM SAFETY AND EFFICACY, FAVORABLE HEMODYNAMIC DATA, AND VERY LOW RATES OF PVL IN AN ANATOMICALLY COMPLEX COHORT. NEW PPM IMPLANTATION REMAINED HIGH. FURTHER STUDY WILL EVALUATE IF INCREASING OPERATOR EXPERIENCE WITH THE DEVICE AND NEW IMPLANTATION TECHNIQUE CAN REDUCE THE INCIDENCE OF PPM IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715023 LOTUS EDGE VALVE SYSTEM LOTUS EDGE TM VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other