HEARTFLOW ANALYSIS
Report
- Report Number
- 3021637148-2025-00009
- Event Type
- Injury
- Date Received
- July 22, 2025
- Date of Event
- May 15, 2025
- Report Date
- March 6, 2026
- Manufacturer
- HEARTFLOW, INC.
- Product Code
- PJA
- PMA / PMN Number
- UNKNOWN
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 501
Narratives
IN THE MULTICENTER DYNAMIC-FFRCT REGISTRY, 410 PARTICIPANTS WHO UNDERWENT FFRCT ANALYSIS UNDER HEALTH INSURANCE REIMBURSEMENT WERE PROSPECTIVELY ENROLLED AT SIX JAPANESE SITES BETWEEN OCTOBER 2019 AND NOVEMBER 2021. IN ACCORDANCE WITH RECENT GUIDELINES, ALL PARTICIPANTS RECEIVED APPROPRIATE REVASCULARIZATION AND/OR OPTIMAL MEDICATION THERAPY AFTER FFRCT. THE FOLLOWING CLINICAL OUTCOMES THROUGH THE 1-YEAR DEFINED MAJOR ADVERSE CARDIOVASCULAR EVENT (MACE) WERE INVESTIGATED: ALL-CAUSE DEATH, CARDIOVASCULAR EVENTS INCLUDING NON-FATAL MYOCARDIAL INFARCTION, AND UNPLANNED HOSPITALIZATION FOR ACUTE CORONARY SYNDROME LEADING TO REVASCULARIZATION. THE FIRST PATIENT CASE WAS ADMITTED FOR RESPIRATORY FAILURE, SECONDARY TO SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE. THEY WERE ELIGIBLE FOR HOME OXYGEN THERAPY RECOMMENDED BY THEIR ATTENDING PHYSICIAN; HOWEVER, THEY REFUSED. DURING HOSPITALIZATION, SIGMOID COLON CANCER WAS DIAGNOSED. WITH THE PLANNED SURGERY, THEIR LIFE EXPECTANCY WAS ESTIMATED TO BE GREATER THAN 1 YEAR. THEY WERE REFERRED TO THE CARDIOLOGY DEPARTMENT TO EVALUATE THEIR TOLERANCE TO SURGERY. CCTA WAS PERFORMED AND REVEALED GREATER THAN OR EQUAL TO 50% STENOSIS OF THE RIGHT CORONARY ARTERY (RCA) ONLY. AFTER CONSENTING TO PARTICIPATE IN THE DYNAMIC-FFRCT REGISTRY, FFRCT WAS PERFORMED. THE FFRCT VALUE FOR THE RCA WAS 0.90, AND PHYSIOLOGICAL ISCHEMIA WAS EXCLUDED. THEREAFTER, THE PARTICIPANT UNDERWENT RESECTION FOR SIGMOID COLON CANCER AND WAS DISCHARGED 7 DAYS POSTOPERATIVELY. THEIR PROGRESS AT THE OUTPATIENT CLINIC CONSULTATIONS WAS UNEVENTFUL; NONETHELESS, THEY EXPERIENCED AN UNKNOWN CARDIOPULMONARY ARREST AT HOME, 178 DAYS AFTER CONSENTING TO PARTICIPATE IN THE DYNAMIC-FFRCT REGISTRY, WHICH WAS 154 DAYS POSTOPERATIVELY. THE SPECIFIC DATE OF DEATH IS UNKNOWN. HEARTFLOW COULD NOT IDENTIFY PATIENT CASE 1 WITH FFRCT GREATER THAN 0.80 AND A MACE OCCURRENCE DESCRIBED IN THE ARTICLE, AND CONSEQUENTLY WE COULD NOT PERFORM A FULL INVESTIGATION. HEARTFLOW'S ANALYSIS INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING WARNING: DUE TO THE VARIABILITY IN THE HEARTFLOW ANALYSIS, THE OUTPUT 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. PUBLICATION CITATION: KOMIYAMA K, TANABE K, TAGUCHI E, SAKAMOTO T, NAKANISHI R, OKUBO R, SAITO A, ASANO T, IKUTA A, KADOTA K, NOZAKI YO, FUJIMOTO S. CLINICAL OUTCOMES OF CORONARY COMPUTED TOMOGRAPHY ANGIOGRAPHY-DERIVED FRACTIONAL FLOW RESERVE. INT HEART J. 2025 MAY 31;66(3):337-344. DOI: 10.1536/IHJ.24-534. EPUB 2025 MAY 15. PMID: 40368767.
THE DATE RECEIVED BY MANUFACTURER WAS 30-MAY-2025.
THE CLINICAL STUDY PARTICIPANT HAD A MAJOR ADVERSE CARDIOVASCULAR EVENT REPORTED WITH THE FFRCT VALUE OF GREATER THAN 0.80 FOR THE RIGHT CORONARY ARTERY (RCA).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 544849 | HEARTFLOW ANALYSIS | HEARTFLOW ANALYSIS | PJA | HEARTFLOW, INC. | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | Death |