HEARTFLOW ANALYSIS

Additional Manufacturer Narrative

AS PART OF HEARTFLOW'S INTERNAL REVIEW, A HEARTFLOW ANALYSIS WAS IDENTIFIED TO HAVE BEEN INCORRECTLY RELEASED WITH FFRCT VALUES PROVIDED FOR THE LEFT ANTERIOR DESCENDING (LAD) SYSTEM WITH A STENT. THE INVESTIGATION DETERMINED FFRCT VALUES WERE INCORRECTLY PROVIDED IN THE LAD SYSTEM DUE TO MISINTERPRETATION OF THE CT DATA BY THE AUTOMATED TECHNOLOGY AND INSPECTION PROCESS. THE PHYSICIAN WAS NOTIFIED OF THE INVESTIGATION RESULTS AND HAS NOT INDICATED A SAFETY EVENT WITH THE PATIENT AT THIS TIME. HEARTFLOW ANALYSIS INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING WARNINGS: DUE TO THE POTENTIAL FOR ARTIFACTS IN THE CT DATA OR DEGRADATION OF CT DATA QUALITY, THE SAFETY AND EFFECTIVENESS OF THE HEARTFLOW ANALYSIS HAS NOT BEEN CLINICALLY EVALUATED FOR THE FOLLOWING POPULATIONS: PATIENTS WITH INTRACORONARY METALLIC STENTS. PATIENTS WITH PRIOR PACEMAKER OR INTERNAL DEFIBRILLATOR LEAD IMPLANTATION. PATIENTS WITH PROSTHETIC HEART VALVES. PATIENTS WITH SIGNIFICANT ARRHYTHMIAS OR TACHYCARDIA (UNCONTROLLED BY MEDICATION) THAT WOULD PRECLUDE CT ACQUISITION. CORONARY VESSELS WITH EXCESSIVE CALCIFICATION. THE HEARTFLOW ANALYSIS HAS BEEN STUDIED IN PATIENTS WITH PRIOR PCI, BUT THE FFRCT VALUES HAVE ONLY BEEN VALIDATED IN VESSELS WITHOUT METALLIC STENTS. 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

HEARTFLOW IDENTIFIED A HEARTFLOW ANALYSIS WAS INCORRECTLY RELEASED WITH FFRCT VALUES PROVIDED FOR THE LEFT ANTERIOR DESCENDING (LAD) SYSTEM WITH A STENT.