BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 5241816 · Received November 21, 2015

    Report

    Report Number
    2916596-2015-02183
    Event Type
    Injury
    Date Received
    November 21, 2015
    Date of Event
    October 17, 2015
    Report Date
    October 26, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 9 DAYS. THE PUMP WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED STROKE COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE LISTS STROKE AND THROMBUS AS POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE USE OF THE 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.

    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 ON (B)(6) 2015, THE PATIENT HAD A BRIEF PERIOD OF STROKE-LIKE SYMPTOMS WITH DIZZINESS AND LEFT SIDED WEAKNESS. THE PATIENT'S PARTIAL THROMBOPLASTIN AT THE TIME WAS 47 SECONDS, WHEREAS IT HAD PREVIOUSLY BEEN 82 SECONDS. HEPARIN DOSING WAS INCREASED AND THE SYMPTOMS SUBSIDED. ON (B)(6) 2015, THE PATIENT EXPERIENCED A RIGHT MIDDLE CEREBRAL ARTERY STROKE AND A THROMBECTOMY WAS PERFORMED. SOME RESIDUAL BLOCKAGE IN THE RIGHT ANTERIOR CEREBRAL ARTERY REMAINED. IT WAS REPORTED THAT THE PATIENT WOULD LIKELY NEED ACUTE REHABILITATION AFTER DISCHARGE FROM THE HOSPITAL DUE TO RESIDUAL LEFT SIDED WEAKNESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771602 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention