BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEERLY LABS

    MDR report key: 19946009 · Received August 8, 2024

    Report

    Report Number
    3017167291-2024-00001
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    March 1, 2023
    Report Date
    August 8, 2024
    Manufacturer
    CLEERLY INC
    Product Code
    LLZ
    UDI-DI
    00860001924114
    PMA / PMN Number
    K202280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT IS BEING SUBMITTED IN AN ABUNDANCE OF CAUTION DUE TO THE DIFFERENCE BETWEEN THE DEGREE OF STENOSIS IDENTIFIED IN THE CLEERLY ANALYSIS AND THE ANGIOGRAPHY REPORTS PERFORMED 3 MONTHS LATER. CLEERLY'S INTERNAL TEAM REANALYZED THE INITIAL CLEERLY RESULTS AND CONFIRMED THE FINDINGS OF MODERATE (CAD-RADS 2) STENOSES IN BOTH THE RCA AND LAD. NONETHELESS, IT REMAINS UNKNOWN WHETHER THE CCTA/CLEERLY UNDERREPORTED THE SEVERITY OF THE STENOSES OR IF THE PATIENT'S DISEASE PROGRESSED IN THE 3 MONTHS BETWEEN THE CCTA/CLEERLY AND THE INVASIVE ANGIOGRAM. THIS EVENT IS BEING SUBMITTED BECAUSE THE LACK OF INITIAL TREATMENT MAY HAVE BEEN THE RESULT OF AN UNCONFIRMED INACCURACY OF THE CLEERLY RESULTS WHICH MAY HAVE CONTRIBUTED TO THIS EVENT. CLEERLY WILL SUPPLEMENT THIS MDR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    A 59 YEAR OLD UNDERWENT CCTA AND CLEERLY ANALYSIS DEMONSTRATING 3-VESSEL CORONARY ARTERY DISEASE (CAD) INCLUDING STAGE 2 (MODERATE) PLAQUE BURDEN (253 MM3 AND 13.7% PERCENT ATHEROMA VOLUME) AS WELL AS THREE CORONARY ARTERY DISEASE - REPORTING AND DATA SYSTEM (CAD-RADS) GRADE 3 (MODERATE) STENOSES INCLUDING THE RIGHT CORONARY ARTERY (RCA), THE, PROXIMAL LAD (PLAD) AND THE PROXIMAL CIRCUMFLEX (PCX). THERE WERE ALSO 7 MILD STENOSES (1-49%) NOTED IN THE RCA, LEFT MAIN, CX AND OM1. THE PATIENT'S CARDIOLOGIST RECOMMENDED THAT SHE UNDERGO CORONARY ARTERY BYPASS (CABG) SURGERY FOR HER 3-VESSEL CAD BUT SHE REFUSED AND ELECTED TO TRY MEDICAL MANAGEMENT.  FIVE MONTHS FOLLOWING THE CCTA AND CLEERLY ANALYSIS, THE PATIENT DEVELOPED ACUTE CHEST PAIN AND SHORTNESS OF BREATH AND WAS DIAGNOSED WITH AN ACUTE INFERIOR ST-ELEVATION MI (STEMI) IN THE RCA AND WAS SENT EMERGENTLY TO THE CARDIAC CATHETERIZATION LAB. IN THE CATH LAB, MULTIVESSEL CAD WITH HEMODYNAMIC SIGNIFICANCE WAS DEMONSTRATED. IN ADDITION SEVERE (CAD-RADS 4) STENOSES WERE NOTED IN THE PLAD (80%), OBTUSE MARGINAL (95%), MRCA (80%), DRCA (90%) AND RIGHT POSTERIOR DESCENDING CORONARY ARTERY (70%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647652 CLEERLY LABS SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ CLEERLY INC V2.0 00860001924114

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Life Threatening