BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3221453 · Received July 9, 2013

    Report

    Report Number
    2916596-2013-00801
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 15, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT WITH THE PUMP. THE DEVICE REMAINS IMPLANTED AND IN USE BY THE PT. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. APPROXIMATELY 20 MONTHS POST IMPLANT, THE PT PRESENTED TO THE EMERGENCY DEPT. IT WAS REPORTED THAT HE HAD A 3 DAY HISTORY OF HEADACHES AND DEVELOPED VOMITING IN THE 24 HOURS PRIOR TO PRESENTATION AT THE HOSPITAL. A URGENT CTB WAS DONE AND THE PT WAS FOUND TO HAVE HAD A LEFT CEREBELLAR HEMORRHAGIC STROKE. THE PT'S ANTICOAGULATION WAS REVERSED WITH PROTHROMBINEX AND NEUROSURGEONS PERFORMED A CRANIOTOMY WHERE AN EXTERNAL VENTRICULAR DRAIN (EVD) WAS INSERTED. THE PT WAS EXTUBATED 1 DAY POST-SURGERY AND WAS REPORTEDLY RESPONDING APPROPRIATELY AND WAS TRANSFERRED TO THE WARD, THE PT REMAINS OFF ANTICOAGULATION AS HE HAD PREVIOUSLY EXPERIENCED GI BLEEDS WHILE ON VAD SUPPORT. THE CARE TEAM PLANS TO RESTART ANTICOAGULATION AT DAY 5 "POST NEUROLOGICAL EVENT" IF ALL CONTINUES WELL. HIS PREVIOUS INTERNATIONAL NORMALIZED RATIO (INR) AIM WAS 2-3 AND HE WAS USING 100MG OF ASPIRIN PER DAY. DUE TO BLEEDING BEING AN ISSUE FOR THIS PT, THE PLAN IS TO CEASE HIS ANTIPLATELET AND USE WARFARIN WITH AN INR AIM OF 1.5 TO 2.5 AS HIS ANTICOAGULATION STRATEGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312056 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103693 101954

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention