BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS VALVE SYSTEM

    MDR report key: 21762219 · Received April 3, 2025

    Report

    Report Number
    2124215-2025-19362
    Event Type
    Injury
    Date Received
    April 3, 2025
    Date of Event
    January 19, 2025
    Report Date
    April 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VAN NULAND, P.J.A., HALIM, J., VAN GINKEL, D.J., OVERDUIN, D.C., BROUWER, J., NIJENHUIS, V.J., VAN'T HOF, A.W.J., TONINO, P.A.L., TEN BERG, J.M. AND VRIESENDORP, P.A. (2025), THE IMPACT OF PERMANENT PACEMAKER IMPLANTATION AFTER TAVI ON MORTALITY AND QUALITY OF LIFE: A POPULAR TAVI SUBSTUDY. CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, 105: 1098-1107. HTTPS://DOI.ORG/10.1002/CCD.31431.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT IMPLANTATION OF PERMANENT PACEMAKERS OCCURRED. A MULTI-YEAR, MULTI-SITE RETROSPECTIVE ANALYSIS BETWEEN THE YEARS 2013 TO 2019 WAS PERFORMED TO STUDY THE IMPACT OF PERMANENT PACEMAKER IMPLANTATION AFTER TRANSCATHETER AORTIC VALVE REPLACEMENT AMONG PATIENTS TREATED WITH ACURATE NEO VALVES, LOTUS VALVES, AND NON-BOSTON SCIENTIFIC (BSC) VALVES. PROPENSITY SCORE MATCHING WAS PERFORMED TO COMPARE GROUPS WITH SIMILAR CHARACTERISTICS. PROCEDURE SUMMARY: NINE HUNDRED AND SEVENTY-EIGHT (978) PATIENTS UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURES FORTY-SIX (46) OF WHICH WERE IMPLANTED WITH A LOTUS VALVE. POST PROCEDURE COMPLICATIONS: THIRTEEN (13) PATIENTS THAT RECEIVED A LOTUS VALVE REQUIRED IMPLANTATION OF A PERMANENT PACEMAKER POST TAVR PROCEDURE. PATIENT STATUS: NO FURTHER INFORMATION ON THE STATUS OF THE PATIENTS IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957279 LOTUS VALVE SYSTEM Aortic valve, prosthesis, percutaneously delivered NPT BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention