BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 14698538 · Received June 15, 2022

    Report

    Report Number
    2916596-2022-11314
    Event Type
    Injury
    Date Received
    June 15, 2022
    Date of Event
    December 31, 2019
    Report Date
    August 9, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    SECTION A;D: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN. SECTION B3: DATE OF EVENT IS APPROXIMATE AS THE DATA WAS COLLECTED BETWEEN 2015 AND 2019. ARTICLE: M. KASSI, ET AL. ASSOCIATION OF OUTFLOW CANNULA ANGULATION WITH ADVERSE NEUROLOGICAL EVENTS IN PATIENTS WITH CF-LVAD, THE JOURNAL OF HEART AND LUNG TRANSPLANTATION, VOL 41, NO 4S, APRIL 2022 CARDIOLOGY, HOUSTON METHODIST HOSPITAL, HOUSTON, TX. MAIN INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE HEARTMATE 3 LVAS AND THE REPORTED ADVERSE NEUROLOGICAL EVENTS COULD NOT BE DETERMINED THROUGH THIS EVALUATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C IS CURRENTLY AVAILABLE. SECTION 1 OF THIS DOCUMENT LISTS OTHER NEUROLOGICAL EVENTS (NOT STROKE-RELATED) AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE "ASSOCIATION OF OUTFLOW CANNULA ANGULATION WITH ADVERSE NEUROLOGICAL EVENTS IN PATIENTS WITH CF-LVAD" IDENTIFYING THAT ADVERSE NEUROLOGICAL OUTCOMES ARE THE "ACHILLES HEEL" OF THE CURRENT DAY LEFT VENTRICULAR ASSIST DEVICE (LVAD) TECHNOLOGY AND ARE ASSOCIATED WITH WORSE SURVIVAL. THE AUTHORS' PREVIOUS DATA SUGGESTS THAT OUTFLOW CANNULA (OFC) ANGLES MEASURED USING CARDIAC COMPUTED TOMOGRAPHY (CT) MAY CORRELATE WITH STROKE IN CONTINUOUS-FLOW HEARTMATE II PATIENTS. THEREFORE, THE AIM OF THE STUDY WAS TO ASSESS THE RELATIONSHIP OF INFLOW CANNULA (IFC) AND OUTFLOW CANNULA (OFC) POSITION WITH NEUROLOGICAL OUTCOMES CENTRIFUGAL FLOW PUMPS (HEARTMATE3 AND HVAD). 108 PATIENTS UNDERWENT LVAD IMPLANTATION BETWEEN 2015 AND 2019 AT THE AUTHORS' INSTITUTION. OF THESE, 68 PATIENTS UNDERWENT CARDIAC CT, AND 6 WERE EXCLUDED DUE TO POOR IMAGE QUALITY. OF THESE PATIENTS, A TOTAL OF 32 NEUROLOGICAL EVENTS (NE) OCCURRED IN 20 PATIENTS. THESE CASES WERE COMPARED TO PATIENTS WITH CT DATA WHO DID NOT HAVE NES. 2D ANGLE MEASUREMENTS WERE PERFORMED ON POSITIONS OF OFC RELATIVE TO THE ASCENDING AORTA AND IFC RELATIVE TO THE MITRAL VALVE. FURTHER, A NOVEL POINT-BASED 3D MEASUREMENT SYSTEM WAS USED TO DETERMINE THE ANGLES IN AN X-Y-Z PLANE. BASELINE DEMOGRAPHIC DATA AND OUTCOME DATA WERE COLLECTED FOR ALL PATIENTS. OPTIMAL CUT-POINT OF THE OFC ANGLE WAS DETERMINED USING RECEIVER OPERATING CHARACTERISTIC (ROC) CURVE ANALYSIS. OF THE 62 PATIENTS RECRUITED FOR THIS STUDY, 65% HAD HM3 AND 35% HAD HVAD. THE MEDIAN OFC ANGLE ON 2D IN PATIENTS WITH NE WAS 59.8 DEGREES RELATIVE TO THE AORTA, COMPARED WITH A MEDIAN ANGLE OF 51.7 DEGREES IN PATIENTS WITHOUT NE (P=0.02). SIMILARLY ON 3D ANGLE MEASUREMENTS, A MEDIAN OFC ANGLE OF 86.7 DEGREE WAS OBSERVED IN PATIENTS WITH NE, COMPARED TO A MEDIAN ANGLE OF 77.4 DEGREES IN PATIENTS WITHOUT NE (P=0.01). IFC ANGLE WAS NOT ASSOCIATED WITH AN INCREASED RISK OF NE. THE ROC CURVE ANALYSIS SHOWED OPTIMAL OFC ANGLE WAS < 53 DEGREES IN 2D MEASUREMENTS, WITH SENSITIVITY OF 79% AND SPECIFICITY OF 61% AT PREDICTING NES. IN 3D MEASUREMENTS THE OPTIMAL OFC ANGLE WAS LESS THAN < 83 DEGREES WITH A SENSITIVITY OF 79% AND A SPECIFICITY OF 61% AT PREDICTING NES. OPTIMAL ANGULATION OF THE OUTFLOW CANNULA IN LVAD PATIENTS CAN LEAD TO DECREASED RISK FOR HRAE. USING CARDIAC CT CHEST IMAGING FOR 2D AND 3D MEASUREMENTS, AN OPTIMAL OUTFLOW CANNULA ANGULATION OF < 53 DEGREES AND < 83 DEGREES, RESPECTIVELY, SHOULD BE PREFERRED TO MINIMIZE THE RISK FOR HRAE IN PATIENTS WITH CENTRIFUGAL FLOW LVAD SUPPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845681 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other