BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6213694 · Received December 29, 2016

    Report

    Report Number
    2916596-2016-02539
    Event Type
    Death
    Date Received
    December 29, 2016
    Date of Event
    December 4, 2016
    Report Date
    April 27, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT EXPLANTED. A DIRECT CORRELATION BETWEEN THE REPORT OF STROKE AND THE DEVICE COULD NOT BE CONCLUSIVELY DETERMINED. STROKE IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II 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

    (B)(4). APPROXIMATE AGE OF DEVICE - 1 YEAR, 7 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2016 DUE TO AN EMBOLIC STROKE. A CT SCAN CONFIRMED THE STROKE. THE PATIENT HAD A THERAPEUTIC INR. THE PUMP WAS NOT EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    862547 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death