MAUDE Adverse Event Report: HEARTFLOW, INC. HEARTFLOW ANALYSIS

Model Number	2.57.0.6
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Code	Angina (1710)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
During review of clinical study data, it was identified that a patient enrolled in the study (b)(6) 2020, had received a heartflow analysis where the patient had a positive lad and an rca with a borderline distal value.The patient was scheduled for a coronary angiogram (cag) due to the lad result.The study investigators reported a potential false negative in the rca as before the scheduled cag, on (b)(6) 2020, the patient was urgently admitted in another hospital due to unstable angina where percutaneous coronary intervention (pci) was performed and the rca 4pd branch was treated with a drug-coated balloon (dcb).
Additional Manufacturer Narrative
As part of heartflow's investigation following the customer report, we reviewed the potential false negative.Heartflow id# (b)(4): the investigation identified the heartflow analysis met device specifications, despite the reported discrepancy.The company representative followed up with the customer for additional invasive information.The customer will be notified of the investigation results.Heartflow's ffrct analysis instructions for use include the following warnings: due to the variability in the heartflow analysis, the ffrct values should be reviewed as one of several clinical data points to be used in conjunction with the patient's original ct images, clinical history, symptoms and other diagnostic tests, as well as an appropriately trained clinician's clinical judgment, to evaluate the patient.The heartflow analysis process is dependent on the quality of the imaging data provided.Ffrct values may be affected by assumptions needed to resolve anatomy in areas of uncertainty, whether provided by the physician or made by heartflow case analysts.The heartflow analysis represents patient conditions at the time of ct acquisition.The duration of time and changes to patient health after ct acquisition must be assessed during interpretation.Clinical validation that supports ffrct values was limited to subjects whose ct acquisition occurred within 60 days of invasive ffr (mean 18 +/- 13 days).Because of physiologic changes in pressure and flow within regions of complex or turbulent flow (i.E.Stenosis, bifurcations), pressure measurements may vary, potentially affecting measured ffr.Similarly, computed ffrct values may be affected by flow disturbances in stenoses and bifurcations.This is representative of physiology and is not a product limitation.
Additional Manufacturer Narrative
The customer provided additional invasive information and the investigation concluded the heartflow analysis still met device specifications.Heartflow will communicate with the customer to review the investigation results.
Additional Manufacturer Narrative
G4 - combination product was checked on followup #2 report by mistake; the device is not a combination product.On the initial report the 510(k) number was provided.
Additional Manufacturer Narrative
Heartflow reviewed the investigation results with the customer.The customer confirmed that after the urgent admission to the hospital, from the patient's electrocardiogram (ecg) leads ii and iii, the treatment of the rca 4pd branch was given priority.No other details are known from the admission hospital about the diagnosis.Several days after the rca 4pd branch was treated, percutaneous coronary intervention (pci) was performed for the lad.Follow up is now done at the customer's hospital.The patient's condition is stable.

• Brand Name: HEARTFLOW ANALYSIS
• Common Device Name: HEARTFLOW ANALYSIS
• Manufacturer (Section D): HEARTFLOW, INC.; 331 e. evelyn; mountain view CA 94041
• Manufacturer (Section G): HEARTFLOW, INC.; 331 e. evelyn; mountain view CA 94041
• Manufacturer Contact: patricia erwin ; 331 e. evelyn; mountain view, CA 94041 ; 6502414547
• MDR Report Key: 15341822
• Report Number: 3021637148-2022-00001
• Device Sequence Number: 5221744
• Product Code: PJA
• UDI-Device Identifier: 00853341006039
• UDI-Public: (01)00853341006039(10)FFRCT_2.57.0.6(11)2020-09-25
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K203329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 2.57.0.6
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Supplement Date Received by Manufacturer: 08/16/2022; 09/30/2022; 09/30/2022
• Initial Report FDA Received Date: 09/01/2022
• Supplement Report FDA Received Date: 10/01/2022; 10/19/2022; 10/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/25/2020
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Unknown