BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTFLOW ANALYSIS

    MDR report key: 23311544 · Received October 16, 2025

    Report

    Report Number
    3021637148-2025-00016
    Event Type
    Injury
    Date Received
    October 16, 2025
    Date of Event
    August 15, 2025
    Report Date
    November 5, 2025
    Manufacturer
    HEARTFLOW, INC.
    Product Code
    PJA
    UDI-DI
    00853341006060
    PMA / PMN Number
    K213857
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    CATHERIZATION ANGIOGRAPHY IMAGES WERE RECEIVED FROM THE CUSTOMER ON 17-OCT-2025. THE SUBSEQUENT EVALUATION NOTED VARIABILITY IN THE LAD AND RCA VESSELS WHEN COMPARED AGAINST THE PROVIDED ANGIO IMAGES. THE CATH REPORT DID NOT MENTION AN OCCLUSION AND WAS NOT VISUALIZED. THE CAUSE OF THE REPORTED DISCREPANCY TO INVASIVE DATA IN THE LAD AND RCA SYSTEMS CONTINUES TO BE UNKNOWN.

    Additional Manufacturer Narrative · 0

    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. THE CAUSE OF THE REPORTED DISCREPANCY TO INVASIVE DATA IN THE LAD AND RCA SYSTEMS IS UNKNOWN. THE MODELED VESSEL SYSTEMS APPEAR TO REFLECT THE SUSPECTED LUMEN BOUNDARIES IN THE CT DATA. THE DISTAL RCA ROADMAP STENOSIS CAPSULE ALIGNS WITH THE STENOSIS REPORTED IN CATHETERIZATION. AN ANALYSIS WAS NOT PROVIDED FOR THE LCX SYSTEM DUE TO THE PRESENCE OF STENTS. HEARTFLOW WILL BE NOTIFYING THE PHYSICIAN OF THE INVESTIGATION RESULTS. 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: 1. PATIENTS WITH INTRACORONARY METALLIC STENTS 2. PATIENTS WITH PRIOR PACEMAKER OR INTERNAL DEFIBRILLATOR LEAD IMPLANTATION 3. PATIENTS WITH PROSTHETIC HEART VALVES 4. PATIENTS WITH SIGNIFICANT ARRHYTHMIAS OR TACHYCARDIA (UNCONTROLLED BY MEDICATION) THAT WOULD PRECLUDE CT ACQUISITION 5. 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 · 0

    THE CUSTOMER REPORTED A POTENTIAL FALSE NEGATIVE RESULT FOR A PATIENT THAT HAD A HEARTFLOW ANALYSIS PERFORMED ON (B)(6) 2025. THE CUSTOMER ADDITIONALLY REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH A ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) POST COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) WITH AN OCCLUSION ON (B)(6) 2025 AND UNDERWENT DIAGNOSTIC CATHETERIZATION. PATIENT RECEIVED STENTS ON (B)(6) 2025. FOLLOW-UP APPOINTMENT WITH PHYSICIAN IS SCHEDULED FOR (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2665464 HEARTFLOW ANALYSIS HEARTFLOW ANALYSIS PJA HEARTFLOW, INC. FFRCT VERSION 3 HFA_3.41.2.4 00853341006060

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R