BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS EDGE VALVE SYSTEM

    MDR report key: 11847953 · Received May 19, 2021

    Report

    Report Number
    2134265-2021-06474
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    February 24, 2021
    Report Date
    May 19, 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
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) STUDY: IT WAS REPORTED THAT ACUTE BACTERIAL ENDOCARDITIS OCCURRED. THE PATIENT WAS ENROLLED INTO THE (B)(6) STUDY IN (B)(6) 2019 AND THE INDEX PROCEDURE WAS PERFORMED ON THE SAME DAY. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN AND THE PATIENT WAS ON A PRIOR REGIMEN OF ASPIRIN OR ANY OTHER ANTIPLATELET MEDICATIONS. LOADING DOSES OF 81 MG OF ASPIRIN AND 300 MG OF CLOPIDOGREL WERE GIVEN THE DAY OF THE PROCEDURE. A LOTUS INTRODUCER WAS PLACED AND THE AORTIC VALVE WAS TREATED WITH BALLOON VALVULOPLASTY AND SUBSEQUENT DEPLOYMENT OF A 25 MM LOTUS EDGE VALVE. TWO DAYS POST INDEX PROCEDURE, THE PATIENT WAS DISCHARGED HOME ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2021, 477 DAYS POST INDEX PROCEDURE, THE PATIENT WAS NOTED WITH ACUTE BACTERIAL ENDOCARDITIS AND AORTIC ROOT ABSCESS. LAB TEST, ECHOCARDIOGRAM AND DIAGNOSTIC CATHERIZATION WERE PERFORMED AS A DIAGNOSTIC PROCEDURE. ON THE SAME DAY, THE PATIENT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. MEDICATION WAS ADJUSTED AND THE AORTIC ROOT WAS REPLACED WITH RADICAL AORTIC ROOT RECONSTRUCTION. THE PATIENT UNDERWENT A MITRAL VALVE REPLACEMENT. ONE MONTH AFTER THE REPORTED OBSERVATION, THE EVENT WAS CONSIDERED RECOVERED AND ON THE SAME DAY THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745844 LOTUS EDGE VALVE SYSTEM LOTUS EDGE TM VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION 10418 0023528222

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R