BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 24582541 · Received March 12, 2026

    Report

    Report Number
    2916596-2026-01356
    Event Type
    Injury
    Date Received
    March 12, 2026
    Date of Event
    March 1, 2026
    Report Date
    May 4, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    05415067039323
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS TURNED AND FLOW DROPPED TO 0.9 AND WAS SUSTAINED THERE, DROPPING TO 0.6L OF FLOW. LOW FLOW ALARMS WERE NOTED. THE PATIENT RETURNED TO THE OPERATING ROOM (OR) FOR A MEDIAN STERNOTOMY- NO TAMPONADE NOTED, NO OUTFLOW GRAFT (OFG) OBSTRUCTION OR PUMP MALPOSITION NOTED. THE PUMP WAS REMOVED AND INGESTION WAS NOTED IN INLET. A NEW HEARTMATE 3 AND OFG WAS IMPLANTED. LOG FILES WERE SUBMITTED FOR REVIEW, AND THE TRENDED EVENT LOG FILE DATA APPEARED TO SHOW A DECREASE IN RECORDED AVERAGE FLOW VALUES AT ON (B)(6) 2026 15:03:25. RECORDED FLOW VALUES REMAINED < 1 LPMS UNTIL THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS STOPPED AND A SYSTEM CONTROLLER SHUTDOWN SEQUENCE WAS COMPLETED AT ON (B)(6) 2026 19:07:27.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195828 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US L00004490 05415067039323

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention