BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 15337952 · Received September 1, 2022

    Report

    Report Number
    2916596-2022-13017
    Event Type
    Injury
    Date Received
    September 1, 2022
    Date of Event
    January 1, 2019
    Report Date
    February 22, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THIS REPORT WAS DETERMINED TO BE SUPPLEMENTAL TO MFR REPORT # 2916596-2019-04412. INVESTIGATION FINDINGS WILL BE REPORTED UNDER MFR REPORT # 2916596-2019-04412.

    Description of Event or Problem · 0

    IT WAS ORIGINALLY REPORTED THROUGH THE RESEARCH ARTICLE ¿OUTFLOW GRAFT OBSTRUCTION IN PATIENTS WITH THE HM 3 LVAD: A PERCUTANEOUS APPROACH¿ UNDER MANUFACTURER REPORT NUMBER 2916596-2019-04412 THAT HEARTMATE (HM) 3 MAY BE RELATED TO OUTFLOW GRAFT OBSTRUCTION (OGO). A TOTAL OF 85 PATIENTS IMPLANTED WITH HM3 BETWEEN 2015 AND 2020 WERE INCLUDED IN THIS RETROSPECTIVE STUDY. ONE 54-YEAR-OLD WOMAN PRESENTED WITH DYSPNEA AND LOW-FLOW ALARMS 13 MONTHS AFTER HM3 IMPLANTATION. SHE HAD SUB-THERAPEUTIC INTERNATIONAL NORMALIZED RATIO (INR), AND WAS PLACED ON INTRAVENOUS HEPARIN. AN INVASIVE HEMODYNAMIC STUDY SHOWED ELEVATED BIVENTRICULAR FILLING PRESSURES WITH NO EFFECT OF PROGRESSIVE SPEED INCREMENTS ON PULMONARY CAPILLARY WEDGE PRESSURE (PCWP). COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) OF THE CHEST SHOWED A SMOOTH FILLING DEFECT WITHIN THE OUTFLOW GRAFT (OG) THOUGHT TO REPRESENT COMPRESSION VERSUS TWISTING OF THE OG. TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED THE ATRIAL VALVE (AV) OPENING WITH EVERY BEAT AND MILD¿MODERATE MITRAL REGURGITATION (MR). INVASIVE ¿GRAFTOGRAPHY¿ VIA THE RIGHT FEMORAL ARTERY (RFA) SHOWED DIFFUSE NARROWING ALONG THE EXTENSION OF THE BEND RELIEF (BR), SUGGESTIVE OF OG EXTERNAL COMPRESSION WITH APPEARANCE OF A POSSIBLE TWIST. REPEAT STERNOTOMY WAS PERFORMED WITH UNTWISTING AND CLIP PLACEMENT. BIOMATERIAL BETWEEN THE OG AND THE BR WAS VISUALIZED AND REMOVED. REPEAT RIGHT HEART CATHETERIZATION (RHC) SHOWED NORMAL FILLING PRESSURES AND REPEAT TTE SHOWED DECOMPRESSED LEFT VENTRICLE AND INTERMITTENT AV OPENING. THE PATIENT WAS DISCHARGED ON WARFARIN AND ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2587731 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 6036878

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention| H