BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS

    MDR report key: 25114051 · Received May 7, 2026

    Report

    Report Number
    MW5187876
    Event Type
    Injury
    Date Received
    May 7, 2026
    Date of Event
    May 4, 2026
    Report Date
    May 5, 2026
    Manufacturer
    THORATEC CORP./ABBOTT LABORATORIES
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    WAS SEEN IN CLINIC BY DR. (B)(6) ON (B)(6) 2026. TRANSTHORACIC ECHOCARDIOGRAM THAT DAY WITH HM3 LEFT VENTRICULAR ASSIST DEVICE AT 5400 RPM, LEFT VENTRICULAR EJECTION FRACTION 10%, LEFT VENTRICULAR INTERNAL DIMENSION AT DIASTOLE 6.4 CM, SEVERELY DILATED RIGHT VENTRICLE WITH SEVERELY REDUCED FXN, MOD-SEVERE TR, MODERATE + AI, AV DOES NOT OPEN, MODERATE TR. NOTED HAD MORE TROUBLE WITH WEIGHT LATELY. FATIGUE EVEN WHEN DIURESED 15 LBS. WITH DECREMENT IN RENAL FUNCTION. PRESENTED FOR RHC WITH RAMP STUDY (B)(6) 2026. THIS SHOWED PA 13, RIGHT VENTRICLE 52/2 (EDP 15), PA 54/22 (34), WEDGE 25, V 38, CI 2.52 AT 163 LBS. WITH MEAN ARTERIAL PRESSURE 75, HEART MATE AT 5400 RPM. CARDIOMEMS RECALIBRATED AND WAS NOTED TO BE ACCURATE - NO SIGNIFICANT CHANGES WERE MADE. SWAN LEFT IN FOR AGGRESSIVE DIURESIS AND REEVALUATION OF PA PRESSURES IN CONSIDERATION FOR AI THERAPIES. CARDIAC POSITRON EMISSION TOMOGRAPHY (B)(6) 2026 WITH NO EVIDENCE OF ACTIVE SARCOIDOSIS. TAVR CTA (B)(6) 2026 WITH TRI LEAFLET AV THAT DOES NOT OPEN WITH SYSTOLE AND SMALL CENTRAL COAPTATION GAP AND ALSO SIGNIFICANT ACCUMULATED BIO DEBRIS IN THE BEND RELIEF STRUCTURE OF THE LEFT VENTRICULAR ASSIST DEVICE OUTFLOW GRAFT RAINING CONCERN FOR POSSIBLE OUTFLOW GRAFT OBSTRUCTION (MINIMAL LUMINAL AREA 6 X 6 MM). (B)(6) 2026: EXTERNAL OUTFLOW GRAFT RELEASE SURGERY - COSTAL INCISION WAS MADE, DISSECTING TOWARDS THE OUTFLOW GRAFT. ONCE IT WAS IDENTIFIED, THE BEND RELIEF GRAFT WAS OPEN LONGITUDINALLY EXPOSING ABUNDANT OLD FIBRIN MATERIAL. ONCE THE OUTFLOW GRAFT WAS RELEASED, THE VAD FLOW INCREASED ALMOST 1 LT INSTANTLY. PATIENT STABLE FOLLOWING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    525478 HEARTMATE 3 LVAS VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORP./ABBOTT LABORATORIES

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Hospitalization| R