BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS VALVE SYSTEM

    MDR report key: 11819482 · Received May 13, 2021

    Report

    Report Number
    2134265-2021-06141
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    August 1, 2007
    Report Date
    May 13, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT APPROXIMATE. DEVICES IMPLANTED BETWEEN (B)(6) 2007 AND (B)(6) 2018. LITERATURE CITATION: OKUNO T, ASAMI M, HEG D, LANZ J, PRAZ F, HAGEMEYER D, BRUGGER N, GRANI C, HUBER A, SPIRITO A, RABER L, STORTECKY S, WINDECKER S, PILGRIM T. IMPACT OF LEFT VENTRICULAR OUTFLOW TRACT CALCIFICATION ON PROCEDURAL OUTCOMES AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. JACC CARDIOVASC INTERV. 2020; 13 (15): 1789-99. RETRIEVED FROM HTTPS://WWW.NCBI.NLM.NIH.GOV/PUBMED/32763071.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE THAT REGURGITATION OCCURRED. TITLE: IMPACT OF LEFT VENTRICULAR OUTFLOW TRACT CALCIFICATION ON PROCEDURAL OUTCOMES AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT. LITERATURE STUDY METHODS: IN A RETROSPECTIVE ANALYSIS OF A PROSPECTIVE SINGLE-CENTER REGISTRY OF PATIENTS THAT UNDERWENT (TAVR) BETWEEN AUGUST 2007 AND JUNE 2018 LEFT VENTRICULAR OUTFLOW TRACT (LVOT) CALCIFICATION WAS ASSESSED IN A SEMIQUANTITATIVE FASHION. MODERATE OF SEVERE LVOT CALCIFICATION WAS DOCUMENTED IN THE PRESENCE OF 2 NODULES OF CALCIFICATION, OR 1 EXTENDING > 5MM IN ANY DIRECTION, OR COVERING >10% OF THE PERIMETER OF THE LVOT. DURING THE STUDY PERIOD, BALLOON EXPANDABLE NON-BOSTON SCIENTIFIC (BSC) VALVE SYSTEMS, SELF EXPANDING NON-BSC VALVE SYSTEMS, ACURATE/ACURATE NEO VALVE SYSTEM AND MECHANICALLY EXPANDABLE LOTUS/LOTUS EDGE VALVE SYSTEMS WERE USED. LITERATURE STUDY RESULTS: AMONG 1,635 PATIENTS UNDERGOING TAVR BETWEEN 2007 AND 2018, MODERATE OR SEVERE LVOT CALCIFICATION WAS FOUND IN 407 PATIENTS (24.9%). PATIENTS WITH MODERATE OR SEVERE LVOT CALCIFICATION HAD SIGNIFICANTLY HIGHER INCIDENCES OF ANNULAR RUPTURE, BAILOUT VALVE-IN-VALVE IMPLANTATION, AND RESIDUAL AORTIC REGURGITATION. BALLOON-EXPANDABLE VALVES CONFERRED A HIGHER RISK OF ANNULAR RUPTURE IN THE PRESENCE OF MODERATE OR SEVERE LVOT CALCIFICATION AS COMPARED WITH THE OTHER VALVE DESIGNS. THERE WAS NO SIGNIFICANT INTERACTION OF VALVE DESIGN AND LVOT CALCIFICATION WITH REGARD TO THE OCCURRENCE OF BAILOUT VALVE-IN-VALVE IMPLANTATION AND RESIDUAL AORTIC REGURGITATION. LITERATURE STUDY CONCLUSIONS: MODERATE OR SEVERE LVOT CALCIFICATION CONFERS INCREASED RISKS OF ANNULAR RUPTURE, RESIDUAL AORTIC REGURGITATION, AND IMPLANTATION OF A SECOND VALVE. THE RISK OF RESIDUAL AORTIC REGURGITATION IS CONSISTENT ACROSS VALVE DESIGNS AND GENERATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715657 LOTUS VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other