BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOTUS EDGE VALVE SYSTEM

    MDR report key: 10780292 · Received November 3, 2020

    Report

    Report Number
    2134265-2020-14169
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    September 21, 2020
    Report Date
    March 25, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 0

    REPRISE IV STUDY. IT WAS REPORTED THAT STROKE OCCURRED. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN. THE SUBJECT WAS ON A PRIOR REGIMEN ASPIRIN AT THE TIME OF INDEX PROCEDURE. THE SUBJECT RECEIVED A LOADING 300 MG OF CLOPIDOGREL. A LOTUS INTRODUCER WAS PLACED AND THEN THE AORTIC VALVE WAS TREATED WITH DEPLOYMENT OF A 27 MM LOTUS EDGE VALVE. SUCCESSFUL REPOSITIONING OF THE 27MM LOTUS EDGE VALVE INVOLVED COMPLETE OR PARTIAL RESHEATHING OF THE 27MM LOTUS EDGE VALVE IN THE DELIVERY SYSTEM CATHETER AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS. POST VALVE PLACEMENT, THE DELIVERY SYSTEM WAS FOUND DIFFICULT OR UNABLE TO BE REMOVED FROM THE BODY. ONE (1) DAY POST INDEX PROCEDURE, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2020, 223 DAYS POST INDEX PROCEDURE, MAGNETIC RESONANCE IMAGING (MRI) AND COMPUTED TOMOGRAPHY (CT) SCANS REVEALED ISCHEMIC STROKE. THE SUBJECT PRESENTED WITH SYMPTOMS OF DIPLOPIA THAT HE HAS HAD ON AND OFF FOR 3 WEEKS. THE SUBJECT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. THE EVENT NIHSS WAS 0. EVENT MRS SCORE WAS NOTED TO BE 0 WITH NO SYMPTOMS AT ALL. THE STROKE WAS CLASSIFIED AS ISCHEMIC BASED ON CLINICAL SYMPTOMS AND NEUROIMAGING. THE FOLLOWING DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. THE SUBJECT'S SYMPTOMS OF DIPLOPIA WAS NOT RESOLVED AT THE TIME OF DISCHARGE. THE EVENT WAS CONSIDERED RECOVERED. IT WAS FURTHER REPORTED THAT THE ISCHEMIC STROKE IS NOT ATTRIBUTED TO THE LOTUS EDGE VALVE.

    Description of Event or Problem · 1

    (B)(6) STUDY . IT WAS REPORTED THAT STROKE OCCURRED. PRIOR TO THE INDEX PROCEDURE, HEPARIN OR OTHER ANTICOAGULANT WAS GIVEN. THE SUBJECT WAS ON A PRIOR REGIMEN ASPIRIN AT THE TIME OF INDEX PROCEDURE. THE SUBJECT RECEIVED A LOADING 300 MG OF CLOPIDOGREL. A LOTUS INTRODUCER WAS PLACED AND THEN THE AORTIC VALVE WAS TREATED WITH DEPLOYMENT OF A 27 MM LOTUS EDGE VALVE. SUCCESSFUL REPOSITIONING OF THE 27MM LOTUS EDGE VALVE INVOLVED COMPLETE OR PARTIAL RESHEATHING OF THE 27MM LOTUS EDGE VALVE IN THE DELIVERY SYSTEM CATHETER AND DEPLOYMENT INTO A MORE ACCURATE POSITION WITHIN THE AORTIC ANNULUS. POST VALVE PLACEMENT, THE DELIVERY SYSTEM WAS FOUND DIFFICULT OR UNABLE TO BE REMOVED FROM THE BODY. ONE (1) DAY POST INDEX PROCEDURE, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2020, 223 DAYS POST INDEX PROCEDURE, MAGNETIC RESONANCE IMAGING (MRI) AND COMPUTED TOMOGRAPHY (CT) SCANS REVEALED ISCHEMIC STROKE. THE SUBJECT PRESENTED WITH SYMPTOMS OF DIPLOPIA THAT HE HAS HAD ON AND OFF FOR 3 WEEKS. THE SUBJECT WAS HOSPITALIZED FOR FURTHER EVALUATION AND TREATMENT. THE EVENT NIHSS WAS 0. EVENT MRS SCORE WAS NOTED TO BE 0 WITH NO SYMPTOMS AT ALL. THE STROKE WAS CLASSIFIED AS ISCHEMIC BASED ON CLINICAL SYMPTOMS AND NEUROIMAGING. THE FOLLOWING DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. THE SUBJECT'S SYMPTOMS OF DIPLOPIA WAS NOT RESOLVED AT THE TIME OF DISCHARGE. THE EVENT WAS CONSIDERED RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1243933 LOTUS EDGE VALVE SYSTEM LOTUS EDGE TM VALVE SYSTEM NPT BOSTON SCIENTIFIC CORPORATION 10418 0024667645

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization