BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3

    MDR report key: 21111455 · Received January 9, 2025

    Report

    Report Number
    21111455
    Event Type
    Injury
    Date Received
    January 9, 2025
    Date of Event
    February 17, 2024
    Report Date
    February 22, 2024
    Manufacturer
    ABBOTT
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT ADMITTED ON (B)(6) 2024 WITH INCREASING SHORTNESS OF BREATH AND LIGHTHEADNESS. LOH ON ADMISSION 275. LOH RANGE 170-240.CAT SCAN PERFORMED (B)(6) 2024 WITH NOTED LUMINAL THROMBUS WITHIN THE PROXIMAL ASPECT OF THE OUTFLOW GRAFT RESULTING IN MODERATE TO SEVERE STENOSIS. PATIENT TAKEN TO SURGERY ON (B)(6) 2024 WITH BEND RELIEF INCISED AND IMMEDIATE RETURN OF SIGNIFICANT AMOUNT OF PROTEINACEOUS DEBRIS. ON (B)(6) 2024 PATIENT NOTED IMPROVEMENT IN RESPIRATORY EFFORT. (B)(6) 2024 LOH 218.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379277 HEARTMATE 3 LEFT VENTRICULAR ASSIST DEVICE BEND DSQ ABBOTT 6969030

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Life Threatening| R