BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6172759 · Received December 13, 2016

    Report

    Report Number
    2916596-2016-02435
    Event Type
    Death
    Date Received
    December 13, 2016
    Date of Event
    November 18, 2016
    Report Date
    July 23, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR EVALUATION. THE REPORT OF POWER ELEVATIONS WAS CONFIRMED BASED ON THE EVALUATION OF THE SUBMITTED SYSTEM CONTROLLER LOG FILE. THE REPORT THAT THE LVAD INFLOW CANNULA WAS MALPOSITIONED WAS NOT CONFIRMED. 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 ¿ 11 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) 2016. IT WAS REPORTED THAT THE LVAD PRODUCED PUMP POWER ELEVATIONS DURING THE POSTOPERATIVE COURSE. THE PATIENT EXPERIENCED RIGHT VENTRICULAR HEART FAILURE, AND ON (B)(6) 2016 THE PATIENT REQUIRED INTUBATION. THE PATIENT¿S SYSTEM CONTROLLER LOG FILE WAS REVIEWED BY A REPRESENTATIVE OF THE MANUFACTURER¿S TECHNICAL SERVICES TEAM AND REVEALED 193 PULSATILITY INDEX (PI) EVENTS WITHIN THE 6 DAYS OF DATA. IT WAS REPORTED THAT THE PATIENT HAD EXPIRED ON (B)(6) 2016. THE PUMP POWER HAD REMAINED INTERMITTENTLY ELEVATED THROUGHOUT THE PATIENT¿S HOSPITAL COURSE. IT WAS REPORTED BY THE VAD CLINICIAN THAT ECHOCARDIOGRAM HAD REVEALED THAT THE LVAD INFLOW CANNULA WAS MALPOSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    820503 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death