BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS EDGE VALVE SYSTEM

    MDR report key: 8750716 · Received July 1, 2019

    Report

    Report Number
    2134265-2019-06891
    Event Type
    Injury
    Date Received
    July 1, 2019
    Date of Event
    May 29, 2019
    Report Date
    July 1, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY IN (B)(6) 2019. IT WAS REPORTED THAT LEFT BUNDLE BRANCH BLOCK (LBBB) AND TYPE-I 2ND DEGREE ARTERIOVENOUS (AV) BLOCK OCCURRED. THE SUBJECT WAS ON A PRIOR REGIMEN OF ANTIPLATELET OTHER THAN ASPIRIN AT THE TIME OF THE INDEX PROCEDURE. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN. THE SUBJECT RECEIVED A LOADING DOSE OF 81 MG OF ASPIRIN. A LOTUS INTRODUCER WAS PLACED AND THEN THE AORTIC VALVE WAS TREATED WITH BALLOON VALVULOPLASTY (BAV) FOLLOWED BY DEPLOYMENT OF A 25 MM LOTUS EDGE VALVE. POST DILATATION WAS NOT PERFORMED. SUCCESSFUL REPOSITIONING OF THE LOTUS EDGE VALVE INVOLVED PARTIAL AND COMPLETE RE-SHEATHING OF THE VALVE IN THE DELIVERY SYSTEM CATHETER AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS. ON THE SAME DAY OF THE INDEX PROCEDURE, POST TRANSCATHETER AORTIC VALVE IMPLANTATION, THE SUBJECT DEVELOPED LBBB. 1 DAY POST INDEX PROCEDURE, THE SUBJECT DEVELOPED TYPE-I 2ND DEGREE AV BLOCK. OF NOTE, NO CONDUCTION DISTURBANCES WERE NOTED POST BAV. AT THE TIME OF REPORTING, THE EVENTS WERE NOT RECOVERED/ NOT RESOLVED. 5 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS NOTED WITH LEFT GROIN PSEUDOANEURYSM. ULTRASOUND WAS PERFORMED AS A DIAGNOSTIC PROCEDURE. NO ACTION WAS TAKEN TO TREAT THE EVENT AND THE VASCULAR SURGEON CONSULTATION WAS RECOMMENDED. AT THE TIME OF REPORTING, THE EVENT WAS CONSIDERED RECOVERED/ RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543330 LOTUS EDGE VALVE SYSTEM LOTUS EDGE TM VALVE SYSTEM 25 MM NPT BOSTON SCIENTIFIC CORPORATION 10418 0023098375

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other