BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS EDGE VALVE SYSTEM

    MDR report key: 11363040 · Received February 22, 2021

    Report

    Report Number
    2134265-2021-01771
    Event Type
    Injury
    Date Received
    February 22, 2021
    Date of Event
    December 20, 2020
    Report Date
    February 22, 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
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(6).

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT ENDOCARDITIS OCCURRED. PROCEDURE SUMMARY: THE SUBJECT WAS ENROLLED INTO THE (B)(6) STUDY AND THE INDEX PROCEDURE WAS PERFORMED THE SAME DAY. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN. THE SUBJECT WAS ON A PRIOR REGIMENT OF ASPIRIN AND ANTIPLATELET MEDICATIONS AT THE TIME OF INDEX PROCEDURE. THE SUBJECT RECEIVED A LOADING DOSE OF 300 MG OF ASPIRIN. A LOTUS INTRODUCER WAS PLACED AND THEN A 25 MM LOTUS EDGE VALVE WAS IMPLANTED SUCCESSFULLY. SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE INVOLVED COMPLETE RE-SHEATHING OF THE LOTUS EDGE VALVE IN THE DELIVERY SYSTEM CATHETER AND DEPLOYMENT INTO A MORE ACCURATE LOCATION WITHIN THE AORTIC ANNULUS. FOUR (4) DAYS LATER, THE SUBJECT WAS DISCHARGED AT HOME ON ANTICOAGULANTS. IN (B)(6) 2020, 374 DAYS POST INDEX PROCEDURE ECHOCARDIOGRAM REVEALED ENDOCARDITIS. ON THE SAME DAY SUBJECT WAS ADMITTED DUE TO THE EVENT AND MEDICATION WAS ADJUSTED TO TREAT THE EVENT. IN (B)(6) 2021, THE EVENT WAS RESOLVED AND ON THE SAME DAY THE SUBJECT DISCHARGED AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259869 LOTUS EDGE VALVE SYSTEM LOTUS EDGE TM VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION 10394 0024176468

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R