BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 7004251 · Received November 6, 2017

    Report

    Report Number
    2916596-2017-02624
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    October 7, 2017
    Report Date
    February 19, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A CORRELATION BETWEEN THE REPORTED STROKE AND THE DEVICE CANNOT BE CONCLUSIVELY DETERMINED. THE PATIENT REMAINS ONGOING ON THE LEFT VENTRICULAR ASSIST SYSTEM (LVAS). NO PRODUCT AVAILABLE FOR INVESTIGATION. THE INSTRUCTIONS FOR USE LISTS STROKE AS A POTENTIAL ADVERSE EVENT ASSOCIATED WITH USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE HEARTMATE 3 LVAS IS USED COMMERCIALLY AND IN THE ONGOING MOMENTUM 3 TRIAL, IDE# G140113. (B)(4). APPROXIMATE AGE OF DEVICE ¿ 18 DAYS.  NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER''S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2017. IT WAS REPORTED THAT, PATIENT WAS THOUGHT TO HAVE EXPERIENCED ENCEPHALOPATHY SINCE CT ON (B)(6) 2017 WAS NEGATIVE AND PATIENT WAS ON SEDATION INFUSION. PATIENT WAS THEN MORE EASILY AROUSABLE. REPEAT CT ON (B)(6) 2017 SHOWED SMALL MIDDLE CEREBRAL ARTERY (MCA) INFARCT. THE PATIENT EXPERIENCED AN ISCHEMIC STROKE. ANTICOAGULANTS AT TIME OF EVENT WERE ASPIRIN AND HEPARIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782449 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R