BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEERLY LABS

    MDR report key: 19946008 · Received August 8, 2024

    Report

    Report Number
    3017167291-2024-00002
    Event Type
    Injury
    Date Received
    August 8, 2024
    Date of Event
    March 1, 2024
    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
    OTHER

    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 INVASIVE ANGIOGRAPHY REPORTS PERFORMED 5 MONTHS LATER. IT REMAINS UNKNOWN WHETHER THE CCTA/CLEERLY UNDERREPORTED THE SEVERITY OF THE STENOSES OR IF THE PATIENT'S DISEASE PROGRESSED IN THE 5 MONTHS BETWEEN THE CCTA/CLEERLY AND THE INVASIVE ANGIOGRAM. THIS EVENT IS BEING SUBMITTED BECAUSE THE LACK OF INITIAL INVASIVE TREATMENT (CABG) 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 67 YEAR OLD ASYMPTOMATIC PATIENT UNDERWENT A CCTA WITH CLEERLY ANALYSIS.  THE CLEERLY ANALYSIS DEMONSTRATED 2-VESSEL CORONARY ARTERY DISEASE (CAD) INCLUDING STAGE 2 (MODERATE) PLAQUE BURDEN (8.7% PERCENT ATHEROMA VOLUME) AS WELL AS TWO CORONARY ARTERY DISEASE - REPORTING AND DATA SYSTEM (CAD-RADS) GRADE 3 (MODERATE 50-69%) STENOSES INCLUDING THE MID RIGHT CORONARY ARTERY (MRCA) AND THE PROXIMAL LAD (PLAD).  THE MID-RCA STENOSIS WAS IDENTIFIED AS A HIGH RISK PLAQUE AS IT CONTAINED LOW-DENSITY PLAQUE (0.8 MM3) AND HAD POSITIVE REMODELING (REMODELING RATIO 1.2).   THE REPORT OF THE CCTA EXAM STATED "THERE IS MULTIVESSEL CORONARY ARTERY DISEASE THAT IS INDETERMINATE FOR HIGH GRADE OBSTRUCTION IN THE PROXIMAL TO MID SEGMENT OF THE LAD, MPI (MYOCARDIAL PERFUSION IMAGING) AND/OR INVASIVE CORONARY ANGIOGRAPHY MAY BE CONSIDERED".   THE PATIENT WAS REFERRED TO CARDIOLOGY BUT DID NOT PROCEED FOR FURTHER TESTING AS RECOMMENDED IN THE CCTA REPORT. PATIENT ALSO REFUSED PRESCRIPTION CAD MEDICATIONS, AND INSTEAD ELECTED TO PROCEED WITH NUTRACEUTICAL THERAPY.   APPROXIMATELY 3 MONTHS AFTER THE CCTA/ CLEERLY TEST, THE PATIENT DEVELOPED ACUTE CHEST PAIN AND UNDERWENT EMERGENT INVASIVE ANGIOGRAPHY AND WAS FOUND TO HAVE TWO 98% BLOCKAGES AND WENT FOR OPEN HEART SURGERY THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647651 CLEERLY LABS SYSTEM, IMAGE PROCESSING, RADIOLOGICAL LLZ CLEERLY INC V2.0 00860001924114

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Life Threatening