BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 24671603 · Received March 23, 2026

    Report

    Report Number
    2916596-2026-01264
    Event Type
    Injury
    Date Received
    March 23, 2026
    Date of Event
    January 14, 2026
    Report Date
    May 15, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE PUMP WAS EXCHANGED. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. INFECTION IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. INFECTION HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PUMP EXCHANGE ON (B)(6) 2026 DUE TO A METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) DRIVELINE INFECTION AND MRSA BACTEREMIA. THE PATIENT WAS INITIALLY ADMITTED ON (B)(6) 2026. THE PATIENT WAS TREATED WITH DAPTOMYCIN 8MG/KG INTRAVENEOUS Q 24HR PRIOR TO THE PUMP EXCHANGE WITH NO RESOLUTION. AFTER THE PUMP WAS EXCHANGED, THE PATIENT WAS CONTINUED ON DAPTOMYCIN 750MG INTRAVENEOUS Q 24HR FOR 6 WEEKS FROM THE LEFT VENTRICULAR ASSIST DEVICE (LVAD) EXCHANGE EOT (B)(6) 2026. THE PATIENT WOULD START DOXYCYCLINE 100MG PO Q 12 HR INDEFINITELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257234 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US L00001159 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Life Threatening| H| R