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	Ischemic Heart Disease (2493)
Date of Event	03/01/2024
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 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.
Event or Problem Description
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. .

• 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: 19946008
• Report Number: 3017167291-2024-00002
• Device Sequence Number: 20634993
• 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: Other
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2024
• 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: 67 YR
• Patient Sex: Male