BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4747071 · Received May 4, 2015

    Report

    Report Number
    2916596-2015-00797
    Event Type
    Death
    Date Received
    May 4, 2015
    Date of Event
    March 1, 2015
    Report Date
    April 6, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 2 YEARS, 3 MONTHS. THE ATTACHED USER FACILITY MEDWATCH REPORT WAS RECEIVED FROM THE INTERMACS REGISTRY. A ROOT CAUSE FOR THE REPORTED EVENT COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. BASED ON THE MANUFACTURER'S PAST EXPERIENCE AND SIMILAR REPORTED EVENTS, ELEVATED LDH, HEMOLYSIS AND RIGHT HEART FAILURE CAN BE INDICATIVE OF DEVICE THROMBOSIS; HOWEVER, A FULL EXAMINATION OF THE PUMP COULD NOT BE CONDUCTED BECAUSE THE DEVICE WAS NOT EXPLANTED. THE INSTRUCTIONS FOR USE LISTS DEVICE THROMBOSIS AND HEMOLYSIS AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT. PLACEHOLDER.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO CONGESTIVE HEART FAILURE. INFORMATION WAS ALSO RECEIVED FROM THE INTERMACS REGISTRY STATING: SUSPECTED PUMP THROMBOSIS. THE VAD COORDINATOR CONFIRMED THAT THE PATIENT¿S CAUSE OF DEATH WAS MULTI SYSTEM ORGAN FAILURE AND HYPERCARBIC RESPIRATORY FAILURE. IT WAS CLARIFIED THAT THE PATIENT HAD BEEN ADMITTED WITH AN ELEVATED LACTATE DEHYDROGENASE (LDH) LEVEL OF 643 U/L WHICH COULD HAVE BEEN HEMOLYZED, AND AN ELEVATED PLASMA FREE HEMOGLOBIN LEVEL OF 324 G/DL. LDH WENT DOWN TO 309 U/L OR LESS DURING THE PATIENT¿S ENTIRE HOSPITAL COURSE AND PLASMA FREE HEMOGLOBIN WENT DOWN TO 70 G/DL THEN 13 G/DL. THE PATIENT HAD A THROMBOELASTOGRAPHY (TEG) EVALUATION WITH A RESULT OF 30. AN ECHOCARDIOGRAM REVEALED NORMAL FLOW THROUGH THE INLET CANNULA; THE OUTLET CANNULA WAS NOT ABLE TO BE VISUALIZED. THERE WAS NO CHANGE IN THE PATIENT¿S LEFT VENTRICLE SIZE FROM HIS PREVIOUS ECHOCARDIOGRAM. THERE WAS NO MENTION OF THROMBOSIS ON THE ECHO REPORT. THE PATIENT¿S URINE WAS DOCUMENTED AS YELLOW DURING HIS HOSPITALIZATION AND HIS INTERNATIONAL NORMALIZED RATIO (INR) WAS SUPRATHERAPEUTIC BETWEEN 4.4-9.6. WITH HIS TEG SHOWING HE WAS HYPERCOAGULABLE EVEN THOUGH HIS INR WAS HIGH, HE WAS KEPT ON BIVALIRUDIN AND THERE WAS MENTION OF "SUSPECTED PUMP THROMBOSIS¿. LVAD PARAMETERS REMAINED NORMAL DURING HOSPITALIZATION UNTIL THE PATIENT WENT TO THE ICU ON AN UNSPECIFIED DATE FOR RESPIRATORY DISTRESS. THE PATIENT WAS DESIGNATED AS DO-NOT-RESUSCITATE AND PASSED AWAY FROM RESPIRATORY FAILURE. AN AUTOPSY WAS NOT PERFORMED. IT WAS REPORTED THAT THE PUMP WAS FUNCTIONING DURING ALL OF THIS UNTIL IT WAS TURNED OFF AT THE TIME OF HIS DEATH; HOWEVER, IT WAS REPORTED THAT IT WAS UNKNOWN IF THE DEVICE CONTRIBUTED TO THE PATIENT¿S DEATH. IT WAS REPORTED THAT THE PATIENT MAY HAVE HAD A PUMP THROMBOSIS, BUT IT WAS NOT CLEAR IF THE PATIENT HAD A PUMP DYSFUNCTION FROM IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291976 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death