MAUDE Adverse Event Report: HEARTFLOW, INC. HEARTFLOW ANALYSIS

Model Number	3.15.0.8
Medical Device Problem Code	False Negative Result (1225)
Health Effect - Clinical Codes	Angina (1710); Dyspnea (1816)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As part of heartflow's investigation following the customer report, we identified a potential false negative.Hfid #(b)(4): the investigation determined that the distal left main coronary artery was modeled larger than what is indicated in the computed tomography data due to an analyst error.The customer was notified of the investigation results.No additional information has been received from the physician at this time.Heartflow's analysis instructions for use include the following warnings: 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 the heartflow analysis was limited to subjects whose ct acquisition occurred within 60 days of invasive ffr (mean 18 +/- 13 days).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.The 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.
Event or Problem Description
Healthcare professional (hcp) reported that a patient had a coronary computed tomography angiography (ccta) performed on (b)(6) 2022 and approximately 1 month later, had a heartflow ffrct analysis performed on 27-sep-2022.The radiologist at the time dictated the left main coronary vessel to be (b)(4).The hcp reported the patient presented with chest pain and dyspnea of exertion (doe), on an unknown date in early 2023, which was worsening status post (s/p).Left heart catheterization (lhc) was performed on (b)(6) 2023, showing severe multivessel coronary artery disease (cad) and left main disease with (b)(4) stenosis now s/p.The patient underwent an urgent coronary artery bypass graft (cabg) surgery x4 ( lima-lad, rad-om1, v-d2, v-pda).

• Brand Name: HEARTFLOW ANALYSIS
• Common Device Name: HEARTFLOW ANALYSIS
• Manufacturer (Section D): HEARTFLOW, INC.; 331 e evelyn ave; mountain view CA 94041
• Manufacturer (Section G): HEARTFLOW, INC.; 331 e evelyn ave; mountain view CA 94041
• Manufacturer Contact: patricia erwin ; 331 e evelyn ave; mountain view, CA 94041 ; 6502414547
• MDR Report Key: 18370041
• Report Number: 3021637148-2023-00008
• Device Sequence Number: 7805928
• Product Code: PJA
• UDI-Device Identifier: 00853341006053
• UDI-Public: (01)00853341006053(10)FFRCT_3.15.0.8(11)2022-09-27
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K213857
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3.15.0.8
• 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: Not provided
• Initial Report FDA Received Date: 12/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Sex: Unknown