BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS VALVE SYSTEM

    MDR report key: 9856015 · Received March 19, 2020

    Report

    Report Number
    2134265-2020-03345
    Event Type
    Injury
    Date Received
    March 19, 2020
    Date of Event
    December 1, 2016
    Report Date
    March 19, 2020
    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

    G DI GIANNUARIO, ET. AL.; MULTIMODALITY IMAGING IN A RARE CASE OF PARAVALVULAR ENDOCARDITIS AROUND THE STENT OF A PERCUTANEOUS LOTUS VALVE; EUROPEAN HEART JOURNAL CARDIOVASCULAR IMAGING (2019) 20 (SUPPLEMENT 1), I117. DATE OF EVENT: EXACT DATE NOT REPORTED. THE FIRST DAY OF THE MONTH OF THE EVENT WAS USED AS AN ESTIMATE. IMPLANT DATE: EXACT DATE NOT REPORTED. THE FIRST DAY OF THE MONTH OF THE IMPLANT WAS USED AS AN ESTIMATE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA LITERATURE THAT FEVER AND ENDOCARDITIS OCCURRED. THE TAVI PROCEDURE WAS PERFORMED IN (B)(6) 2016, IN DECEMBER THE PATIENT HAD AN EPISODE OF STRANGURY FOLLOWED BY PERSISTENT FEVER FOR WEEKS. IN JANUARY WAS PERFORMED A TRANSOESOPHAGEAL ECHOCARDIOGRAPHY (TOE) WITH EVIDENCE OF HYPERECHOIC THICKENING AROUND THE VALVULAR STENT AND VACUOLATION , AFTER ONE WEEK THE EXAMINATION SHOWED A PROGRESSION OF THE VACUOLATION. WE SUBMITTED THE PATIENT TO A NUCLEAR IMAGING EVALUATION WITH THE IDENTIFICATION OF A CORRESPONDING AREA OF INFECTION LOCALIZATION. THE PATIENT WAS SUBMITTED TO A SURGICAL AORTIC VALVE REPLACEMENT WITH BIOLOGICAL PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316719 LOTUS VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention