BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS EDGE VALVE SYSTEM

    MDR report key: 11331595 · Received February 16, 2021

    Report

    Report Number
    2134265-2021-01696
    Event Type
    Injury
    Date Received
    February 16, 2021
    Date of Event
    January 25, 2021
    Report Date
    February 16, 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
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT MODERATE AORTIC REGURGITATION OCCURRED. THE PATIENT WAS ENROLLED INTO THE REPRISE III 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 NOT ON A PRIOR REGIMEN OF ASPIRIN OR OTHER ANTIPLATELET MEDICATIONS. A LOADING DOSE OF 81 MG OF ASPIRIN AND 300 MG OF CLOPIDOGREL WAS 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. SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE INVOLVED COMPLETE RE-SHEATHING AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS, IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). TWO DAYS POST INDEX PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2021, 726 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR A SCHEDULED 24 MONTH FOLLOW-UP VISIT. TRANSTHORACIC ECHOCARDIOGRAM ASSESSMENT REVEALED MODERATE AORTIC REGURGITATION. NO ACTION WAS TAKEN TO TREAT THE EVENT. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED NOT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    228468 LOTUS EDGE VALVE SYSTEM LOTUS EDGE TM VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION 10418 0023023380

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other