MAUDE Adverse Event Report: CLEERLY INC CLEERLY LABS; SYSTEM, IMAGE PROCESSING, RADIOLOGICAL

Model Number	V2.0
Medical Device Problem Code	Inaccurate Information (4051)
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	03/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
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%).

• Brand Name: CLEERLY LABS
• Common Device Name: SYSTEM, IMAGE PROCESSING, RADIOLOGICAL
• Manufacturer (Section D): CLEERLY INC; 1099 18th street; suite 2860; denver CO 80202
• Manufacturer (Section G): CLEERLY, INC.; 1099 18th street; suite 2860; denver CO 80202
• Manufacturer Contact: kristen dejeu ; 1099 18th street; suite 2860; denver, CO 80202 ; 6463624255
• MDR Report Key: 19946009
• Report Number: 3017167291-2024-00001
• Device Sequence Number: 15255909
• Product Code: LLZ
• UDI-Device Identifier: 00860001924114
• UDI-Public: 00860001924114
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K202280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: V2.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 59 YR
• Patient Sex: Female