HEARTFLOW ANALYSIS
Received Jul 2, 2026 · Event occurred Jun 3, 2026
Report 3021637148-2026-00006 · MDR key 25699771
Device
Product problems
- False Negative Result
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
AS PART OF HEARTFLOW'S INTERNAL REVIEW, WE IDENTIFIED A POTENTIAL FALSE NEGATIVE. THE INVESTIGATION DETERMINED THAT THE LEFT MAIN BIFURCATION WAS MODELED LARGER THAN WHAT WAS INDICATED IN THE CT DATA DUE TO MISINTERPRETATION BY THE AUTOMATED TECHNOLOGY AND INSPECTION PROCESS. THE PHYSICIAN WAS NOTIFIED OF THE INVESTIGATION FINDINGS AND HAS NOT REPORTED A PATIENT SAFETY EVENT AT THIS TIME. 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.
Description of Event or Problem
HEARTFLOW IDENTIFIED A POTENTIAL FALSE NEGATIVE RESULT.