BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2800384 · Received October 16, 2012

    Report

    Report Number
    2916596-2012-00989
    Event Type
    Death
    Date Received
    October 16, 2012
    Date of Event
    September 16, 2012
    Report Date
    September 17, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT AFTER 6 MONTHS OF SUPPORT, THE PT¿S CLINICAL CONDITION PROGRESSIVELY DECLINED TO MULTI-ORGAN FAILURE. THE PT SUBSEQUENTLY EXPIRED DUE TO NONISCHEMIC CARDIOMYOPATHY (NICM) CONGESTIVE HEART FAILURE (CHF). ACCORDING TO THE ADD¿L INFO PROVIDED BY THE VAD COORDINATOR, THE PT HAD REMAINED HOSPITALIZED POST IMPLANT OF THE LVAD. AFTER TWO MONTHS OF SUPPORT ON THE LVAD, THE PT HAD BEEN DIAGNOSED WITH A DRIVE-LINE INFECTION. THE PT HAD ALSO STARTED EXPERIENCING POWER FLUCTUATIONS BETWEEN 10-12 WATTS AND WAS MEDICALLY MAINTAINED WITH AGRANOX. THE PT HAD REPORTEDLY FALLEN ON HIS BACK AND INCURRED A SUBDURAL HEMATOMA. OTHER PT¿S HISTORICAL CONDITIONS REPORTED WERE OBESITY WITH A BODY MASS INDEX (BMI) OF 35, A HISTORY OF HEART FAILURE INCLUDING HYPONATREMIA, RENAL FAILURE, RIGHT HEART FAILURE (RHF). THE PT WAS ALSO LISTED FOR BOTH HEART AND KIDNEY TRANSPLANTATION AND WAS BEING MEDICALLY MAINTAINED ON SILDENIFIL. THERE WAS SOME CONCERN OF INFECTION BASED ON BLOOD CULTURES TAKEN AS WELL AS SERATIA GROWTH IN THE DRIVE-LINE AREA. A FEW DAYS PRIOR TO THIS REPORTED EVENT, THE CENTRAL VENOUS PRESSURE (CVP) WAS ELEVATED, THE PT DEVELOPED PULMONARY EDEMA AND WAS INTUBATED . THE PT¿S LAB WORK REVEALED ELEVATED LACTIC ACID LEVELS AND A TRANS-ESOPHAGEAL ECHOCARDIOGRAM (TEE) PERFORMED BY THE HOSPITAL REVEALED DIMINISHED FLOW IN THE INFLOW CANNULA. THE FAMILY REQUESTED THE HOSPITAL TO MEDICALLY MANAGE THE PT AND NOT PERFORM A PUMP EXCHANGE. THE PT SUBSEQUENTLY EXPIRED AFTER EXTUBATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 111117

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Death