BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6037968 · Received October 18, 2016

    Report

    Report Number
    2916596-2016-02014
    Event Type
    Death
    Date Received
    October 18, 2016
    Date of Event
    September 19, 2016
    Report Date
    December 12, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE UNIQUE IDENTIFIER (UDI) ¿ DEVICE WAS MANUFACTURED PRIOR TO THE UDI LABELING IMPLEMENTATION. APPROXIMATE AGE OF DEVICE - 3 YEARS, 7 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT EXPLANTED AND WAS THEREFORE NOT AVAILABLE FOR EVALUATION. A CORRELATION BETWEEN THE DEVICE, THE REPORTED ADVERSE EVENTS AND SUBSEQUENT PATIENT OUTCOME COULD NOT BE CONCLUSIVELY DETERMINED. THROUGH THIS EVALUATION. RENAL FAILURE, HEPATIC DYSFUNCTION, RESPIRATORY FAILURE, CARDIAC ARRHYTHMIA, INFECTION AND NEUROLOGIC DYSFUNCTION ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. 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) 2013. IT WAS REPORTED THAT THE PATIENT HAD AN EXTENSIVE HISTORY OF ISCHEMIC CARDIOMYOPATHY STATUS POST LVAD PLACEMENT IN 2013. THE PATIENT ALSO EXPERIENCED CHRONIC RESPIRATORY FAILURE REQUIRING VENTILATOR DEPENDENCY AND A TRACHEOSTOMY SINCE 2013, CHRONIC KIDNEY DISEASE, CHRONIC DRIVELINE INFECTION, HYPERTENSION, HISTORY OF VENTRICULAR TACHYCARDIA, CHRONIC OBSTRUCTIVE PULMONARY DISEASE PRESENTING WITH NAUSEA/VOMITING, ELEVATED POTASSIUM AND HEART FAILURE EXACERBATION. THE PATIENT HAD A LONG ADMISSION WITH HEART FAILURE EXACERBATION. THE PATIENT WAS TREATED FOR CELLULITIS SECONDARY TO VOLUME OVERLOAD, AND WAS SEEN BY INFECTIOUS DISEASE AND DERMATOLOGY. IN ADDITION, THE PATIENT WAS TREATED WITH INTRAVENOUS ANTIBIOTICS FOR A GRAM NEGATIVE BACTEREMIA. END-STAGE HEART FAILURE CONTINUED AFTER ATTEMPTS AT DIURESIS WITH INOTROPE DEPENDENCE. THE PATIENT'S COURSE WAS COMPLICATED BY POOR RENAL FUNCTION RESULTING IN END-STAGE HEART FAILURE AND CARDIOGENIC SHOCK, LIVER FAILURE, AND ENCEPHALOPATHY. THE PALLIATIVE CARE SERVICE WAS FOLLOWING THE PATIENT SECONDARY TO DECLINE IN FUNCTION AND LACK OF RESPONSE TO TREATMENT. THE PATIENT AND FAMILY DECIDED AGAINST CARDIOPULMONARY RESUSCITATION. THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS TURNED OFF. THE PATIENT'S CONDITION CONTINUED TO DECLINE DESPITE TREATMENT. ON (B)(6) 2016, THE PATIENT BECAME UNRESPONSIVE. THE FOLLOWING DAY AT 0100, THE PATIENT BECAME BRADYCARDIC AND THE PATIENT'S HEART WAS ASYSTOLIC AT 0133. THE LVAD AND VENTILATOR WERE TURNED OFF SECONDARY TO ASYSTOLE. THE PATIENT WAS ABSENT OF HEART TONES OR SPONTANEOUS RESPIRATIONS. THE PATIENT EXPIRED, AND AN AUTOPSY WAS NOT REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689913 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death