HEARTFLOW ANALYSIS

Additional Manufacturer Narrative

AS PART OF HEARTFLOW¿S INVESTIGATION FOLLOWING THE CUSTOMER REPORT, WE REVIEWED THE POTENTIAL FALSE NEGATIVE. THE INVESTIGATION DETERMINED THE CASE WAS MODELED ACCORDING TO THE VALIDATED PRODUCT AT THE TIME OF THE ANALYSIS. THE COMBINATION OF PLAQUE, ARTIFACT, AND/OR SERIES VARIATION CAN IMPACT THE FINAL PRODUCT OUTPUT. SPECIFICALLY, THE MODELED LAD SYSTEM APPEARS TO REFLECT THE SUSPECTED LUMEN BOUNDARIES VISIBLE IN THE AVAILABLE CT DATA. HEARTFLOW COULD NOT DETERMINE THE CAUSE OF THE DISCREPANCY BETWEEN THE HEARTFLOW ANALYSIS AND THE INVASIVE DATA PROVIDED BY THE CUSTOMER. THE MODELING PROVIDED TO THE CUSTOMER FOR THE PROXIMAL LAD, DISTAL LAD, AND LCX APPEAR SIMILAR TO WHAT IS INDICATED BY ANGIOGRAPHY. 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. 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.

Description of Event or Problem

THE CUSTOMER REPORTED A POTENTIAL FALSE NEGATIVE RESULT FOR A PATIENT THAT HAD A HEARTFLOW ANALYSIS PERFORMED ON (B)(6) 2026 INDICATING NO SIGNIFICANT STENOSIS FOR THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE CUSTOMER ADDITIONALLY REPORTED THE PATIENT PRESENTED ON (B)(6) 2026 WITH A NON-ST-ELEVATION MYOCARDIAL INFARCTION (NSTEMI). THE ANGIOGRAM PERFORMED ON (B)(6) 2026 SHOWED SEVERE STENOSIS. THE CUSTOMER REPORTED THAT THE PATIENT IS WELL CLINICALLY, THE LEFT VENTRICLE (LV) FUNCTION ON THE ECHOCARDIOGRAM WAS NORMAL AND DOES NOT ANTICIPATE LONG-TERM ADVERSE OUTCOMES.