BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS EDGE VALVE SYSTEM

    MDR report key: 10656242 · Received October 9, 2020

    Report

    Report Number
    2134265-2020-13654
    Event Type
    Injury
    Date Received
    October 9, 2020
    Date of Event
    September 22, 2020
    Report Date
    November 5, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    REPRISE IV STUDY. IT WAS REPORTED THAT VALVE THROMBOSIS, AORTIC STENOSIS, DYSPNEA AND FATIGUE OCCURRED. THE SUBJECT WAS ENROLLED INTO THE REPRISE IV 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. THE SUBJECT WAS ON A PRIOR REGIMEN ASPIRIN AND OTHER ANTIPLATELET MEDICATION AT THE TIME OF INDEX PROCEDURE. THE SUBJECT RECEIVED A LOADING DOSE OF 300 MG OF CLOPIDOGREL. A LOTUS INTRODUCER WAS PLACED AND THEN THE AORTIC VALVE WAS TREATED WITH SUBSEQUENT DEPLOYMENT OF A 27 MM LOTUS EDGE VALVE. THERE WAS CORRECT POSITIONING OF A SINGLE PROSTHETIC HEART VALVE INTO THE PROPER ANATOMICAL LOCATION. TWO DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2020, 377 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED FOR PROTOCOL SCHEDULED 12-MONTH FOLLOW-UP VISIT. THE SUBJECT'S AORTIC VALVE VELOCITIES WERE SIGNIFICANTLY INCREASED COMPARED TO PREVIOUS ECHOCARDIOGRAM (ECHO) AND SUBJECT WAS STARTED ON COUMADIN. COMPUTED TOMOGRAPHY (CT) WAS PERFORMED AND REVEALED THE PRESENCE OF PROSTHETIC AORTIC VALVE THROMBOSIS. TEN DAYS LATER, THE SUBJECT WAS ADVISED TO VISIT THE EMERGENCY DEPARTMENT AND ON PRESENTATION HAD COMPLAINTS OF PROGRESSIVELY WORSENING DYSPNEA ON EXERTION AND FATIGUE. THE SUBJECT WAS HOSPITALIZED FOR EVALUATION AND TREATMENT. THE SUBJECT WAS RECOMMEND TO START ON ELIQUIS AND DISCONTINUE COUMADIN FOR THE EVENT. FIVE (5) DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND ELIQUIS. IT WAS FURTHER REPORTED THAT IN (B)(6) 2020, AORTIC VALVE STENOSIS WAS ALSO OBSERVED DURING TESTING AS A RESULT OF THICKENED LEAFLETS, MODERATE MITRAL ANNULAR CALCIFICATION AND MILD LEFT VENTRICULAR HYPERTROPHY.

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT VALVE THROMBOSIS, DYSPNEA AND FATIGUE OCCURRED. THE SUBJECT WAS ENROLLED INTO (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. THE SUBJECT WAS ON A PRIOR REGIMEN ASPIRIN AND OTHER ANTIPLATELET MEDICATION AT THE TIME OF INDEX PROCEDURE. THE SUBJECT RECEIVED A LOADING DOSE OF 300 MG OF CLOPIDOGREL. A LOTUS INTRODUCER WAS PLACED AND THEN THE AORTIC VALVE WAS TREATED WITH SUBSEQUENT DEPLOYMENT OF A 27 MM LOTUS EDGE VALVE. THERE WAS CORRECT POSITIONING OF A SINGLE PROSTHETIC HEART VALVE INTO THE PROPER ANATOMICAL LOCATION. TWO DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2020, 377 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED FOR PROTOCOL SCHEDULED 12-MONTH FOLLOW-UP VISIT. THE SUBJECT'S AORTIC VALVE VELOCITIES WERE SIGNIFICANTLY INCREASED COMPARED TO PREVIOUS ECHOCARDIOGRAM (ECHO) AND SUBJECT WAS STARTED ON COUMADIN. COMPUTED TOMOGRAPHY (CT) WAS PERFORMED AND REVEALED THE PRESENCE OF PROSTHETIC AORTIC VALVE THROMBOSIS. TEN DAYS LATER, THE SUBJECT WAS ADVISED TO VISIT THE EMERGENCY DEPARTMENT AND ON PRESENTATION HAD COMPLAINTS OF PROGRESSIVELY WORSENING DYSPNEA ON EXERTION AND FATIGUE. THE SUBJECT WAS HOSPITALIZED FOR EVALUATION AND TREATMENT. THE SUBJECT WAS RECOMMEND TO START ON ELIQUIS AND DISCONTINUE COUMADIN FOR THE EVENT. FIVE (5) DAYS LATER, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND ELIQUIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1121378 LOTUS EDGE VALVE SYSTEM LOTUS EDGE TM VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION 10418 0023922417

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R