BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC® HEARTMATE 3® LVAS IMPLANT KIT

    MDR report key: 24619975 · Received March 17, 2026

    Report

    Report Number
    2916596-2026-01445
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    October 1, 2025
    Report Date
    May 4, 2026
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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'S OUTFLOW GRAFT (OFG) HAD DEVELOPED A KINK, SO THE PATIENT UNDERWENT AN OFG REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484734 THORATEC® HEARTMATE 3® LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 9157802 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male