BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 23843860 · Received December 18, 2025

    Report

    Report Number
    2916596-2025-07816
    Event Type
    Injury
    Date Received
    December 18, 2025
    Date of Event
    November 26, 2025
    Report Date
    January 26, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    05415067038906
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THERE WERE NO DEVICE RELATED ISSUES WITH (B)(6) REPORTED OR IDENTIFIED THROUGH THIS EVALUATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV C, AND THE HEARTMATE 3 LVAS PATIENT HANDBOOK, REV B, ARE CURRENTLY AVAILABLE. THE CURRENT REVISIONS OF THE IFU AND PATIENT HANDBOOK CAN BE FOUND ON THE EIFU PAGE OF THE ABBOTT WEBSITE. ALTHOUGH NO DEVICE-RELATED ISSUES WERE REPORTED, SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    IT WAS LATER CONFIRMED THAT THE PATIENT HAD A RESECTION OF A LEFT VENTRICULAR ANEURYSM WITH REMOVAL OF EXISTING THROMBOTIC MASSES. THE PROCEDURE WAS DONE AS THE 1ST STAGE OF HEARTMATE 3 (HM3) IMPLANTATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FTR THE PATIENT LEFT VENTRICULAR-ANEURYSMECTOMY, WITH SMALT LEFT VENTRICULAR CAVITY, HOSPITAL REQUESTED TO DRS FLOW LRM TO AVOID INCREASED STRESS TO PATIENT AND THEIR RELATIVES. THERE WERE NOT ANY CHANGES TO PATIENT CONDITION OR ANTICOAGULATION STATUS THAT MAY HAVE CONTRIBUTED. THE PATIENT WAS STABLE, WITH CONTINUATION OF STANDARD HEART FAILURE THERAPY, ACCORDING TO GUIDELINES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2242924 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524INT L00003873 05415067038906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention