BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FFRCT

    MDR report key: 11719122 · Received April 23, 2021

    Report

    Report Number
    3011276938-2021-00002
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    March 13, 2021
    Report Date
    April 23, 2021
    Manufacturer
    HEARTFLOW, INC.
    Product Code
    PJA
    UDI-DI
    00853341006039
    PMA / PMN Number
    K203329
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF HEARTFLOW'S INVESTIGATION FOLLOWING THE CUSTOMER REPORT, WE IDENTIFIED A POTENTIAL FALSE NEGATIVE. HFID # (B)(4): THE INVESTIGATION IDENTIFIED A POTENTIAL FALSE NEGATIVE IN THE LAD AND DIAGONAL; AFTER THE INITIAL ANALYSIS WAS DELIVERED, A SECOND ANALYSIS DURING THE INVESTIGATION RESULTED IN DECREASE IN THE DISTAL FFRCT VALUE FROM 0.83 TO <0.50 ON THE LAD AND 0.92 TO 0.74 ON THE DIAGONAL. HEARTFLOW INFORMED THE CUSTOMER OF THE INVESTIGATION RESULTS. THE CUSTOMER CONFIRMED AGAIN THAT THE PATIENT HAD WALL MOTION ABNORMALITIES AT THE TIME THEY PRESENTED WITH THE ACUTE EVENT. THE PATIENT HAD DEGRADED LV FUNCTION. THE PATIENT CONDITION CHANGED AFTER THE ORIGINAL CORONARY COMPUTED TOMOGRAPHY ANGIOGRAPHY (CCTA). HEARTFLOW'S FFRCT ANALYSIS INSTRUCTIONS FOR USE INCLUDE THE FOLLOWING WARNINGS: DUE TO THE VARIABILITY IN THE HEARTFLOW ANALYSIS, THE FFRCT VALUES 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. QUALITATIVE ANATOMICAL INFORMATION PRESENTED ON THE 3D/2D COMPUTER GENERATED ANATOMICAL MODELS IS FOR ORIENTATION PURPOSES ONLY. QUANTITATIVE LUMEN DIAMETER IS REPRESENTATIVE OF THE GEOMETRIC MODEL AND THE ACCURACY IS DEPENDENT ON THE QUALITY OF THE CT DATA PROVIDED. IT DOES NOT REPRESENT ARTERY DIAMETER AND SHOULD NOT BE USED FOR TREATMENT DECISIONS. DIAGNOSTIC PERFORMANCE OF FFRCT USING FFRCATH AS THE REFERENCE STANDARD IS: 86% ACCURATE, 84% SENSITIVE, AND 86% SPECIFIC. 2. REFER TO PRODUCT INSTRUCTIONS FOR USE FOR PATIENT POPULATIONS IN WHICH FFRCT HAS BEEN CLINICALLY EVALUATED, RELEVANT CLINICAL DATA, AND PRODUCT WARNINGS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A FALSE NEGATIVE RESULT AND THE PATIENT HAD AN ACUTE EVENT WITH LAD AND DIAGONAL INFARCTS. THE COMPANY REPRESENTATIVE FOLLOWED UP WITH THE CUSTOMER FOR ADDITIONAL INFORMATION CONFIRMING THE PATIENT PRESENTED WITH CHEST PAIN, AND HAD AN ECHO AND TROPONIN TESTS PERFORMED. THE PATIENT HAD 'WALL MOTION ABNORMALITY' ON ECHO AND ELEVATED TROPONINS. THE PATIENT HAD AN EMERGENCY PERCUTANEOUS CORONARY INTERVENTION (PCI) INCLUDING AN INVASIVE CORONARY ANGIOGRAPHY (ICA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611530 FFRCT HEARTFLOW FFRCT PJA HEARTFLOW, INC. 2.62.1.1 00853341006039

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R