HEARTFLOW ANALYSIS

Additional Manufacturer Narrative

AS PART OF HEARTFLOW'S INTERNAL REVIEW, WE IDENTIFIED A POTENTIAL FALSE NEGATIVE. THE INVESTIGATION DETERMINED THAT THE LEFT CIRCUMFLEX (LCX) WAS MODELED LARGER THAN INDICATED IN THE COMPUTED TOMOGRAPHY (CT) DATA DUE TO MISINTERPRETATION BY HEARTFLOW'S AUTOMATED TECHNOLOGY AND INSPECTION PROCESS. HEARTFLOW WILL NOTIFY THE PHYSICIAN IN CARE OF THE PATIENT OF THE INVESTIGATION FINDINGS. WHILE HEARTFLOW HAS IDENTIFIED THIS ISSUE, THE PHYSICIAN HAS NOT PROVIDED FEEDBACK, NOR INDICATED A SAFETY EVENT WITH THE PATIENT. HEARTFLOW ANALYSIS INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING WARNINGS: 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.