BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4973599 · Received August 5, 2015

    Report

    Report Number
    2916596-2015-01445
    Event Type
    Death
    Date Received
    August 5, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE: 1 YEAR, 1 MONTH. THE DEVICE WAS RETURNED FOR ANALYSIS. EVALUATION IS NOT COMPLETE. NO FURTHER INFORMATION IS AVAILABLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. EVALUATION OF THE RETURNED LVAD PUMP REVEALED DEPOSITION IN THE INFLOW KNITTED GRAFT, INLET ELBOW, OUTLET GRAFT, INLET STATOR, AND ROTOR BODY. HOWEVER, A CORRELATION BETWEEN THE FOUND DEPOSITION AND THE REPORTED THROMBUS, STROKE, AND INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. THE DEPOSITION IN THE INFLOW GRAFT, INLET ELBOW, INLET STATOR, AND ROTOR SHOWED NO STRUCTURE OR LAMINATION AND APPEARED TO BE THE RESULT OF BLOOD REMAINING INSIDE THE PUMP POST-EXPLANT. THERE WAS NO EVIDENCE TO SUGGEST THAT THIS DEPOSITION WAS PRESENT WHILE THE PUMP WAS OPERATING. THE DEPOSITION IN THE OUTFLOW GRAFT WAS CONSISTENT WITH CLOTTED BLOOD REMAINING INSIDE THE GRAFT POST-EXPLANT, BUT HAD SOME TISSUE LIKE QUALITIES. THE DEPOSITION MAY HAVE DEVELOPED AT THIS LOCATION DUE TO POOR SURFACE WASHING AS A RESULT OF A LOW FLOW CONDITION. HOWEVER, A SPECIFIC CAUSE FOR A LOW FLOW EVENT AND A SPECIFIC TIME PERIOD IN WHICH IT DEVELOPED COULD NOT BE CONCLUSIVELY DETERMINED. ELECTRICAL CONTINUITY TESTING OF THE RETURNED PORTION OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. THE PUMP WAS CLEANED, REASSEMBLED, AND FUNCTIONALLY TESTED UNDER NORMAL OPERATING CONDITIONS USING A MOCK CIRCULATORY LOOP. THE DATA RETRIEVED FROM THAT TESTING REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES, COMPARABLE TO WHAT WAS RECORDED DURING THE MANUFACTURING PROCESS AND THE DEVICE FUNCTIONED AS INTENDED. NO FURTHER INFORMATION WAS PROVIDED. 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). IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2015 AFTER SUPPORT WAS WITHDRAWN. THE FOLLOWING PREVIOUSLY UNREPORTED HISTORY WAS PROVIDED. THE PATIENT WAS IMPLANTED WITH THE LVAD ON (B)(6) 2014. POST-IMPLANT THE PATIENT REQUIRED HEMODIALYSIS FOR APPROXIMATELY 6 MONTHS; HER KIDNEYS RECOVERED ENABLING DISCHARGE FROM THE HOSPITAL ON (B)(6) 2014. ON (B)(6) 2014 THE PATIENT REPORTEDLY FELL AT HOME RESULTING IN A CEREBRAL HEMORRHAGE. THE INR VALUE AT THE TIME WAS 2.4-2.7. NO INFORMATION REGARDING THE HEMORRHAGE OR ANY ADVERSE SEQUELAE WAS PROVIDED. ON (B)(6) 2015 BLOOD CULTURES WERE POSITIVE FOR (B)(6). IT WAS REPORTED THAT A SOURCE FOR THE BACTEREMIA WAS NOT IDENTIFIED. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED ON (B)(6) 2015 THAT SHOWED: SEVERELY DEPRESSED LEFT VENTRICULAR SYSTOLIC FUNCTION WITH AN EJECTION FRACTION OF 15-20%, RIGHT VENTRICULAR ENLARGEMENT WITH MODERATELY DEPRESSED SYSTOLIC FUNCTION, BI-ATRIAL ENLARGEMENT, MILD MITRAL AND MODERATE-TO-SEVERE TRICUSPID REGURGITATION. ADDITIONALLY, THE LEFT ATRIUM WAS MILDLY ENLARGED WITH NO VISUALIZED THROMBUS, NO EVIDENCE OF AN INTRA-CARDIAC MASS AND NO VEGETATION NOTED. THE PATIENT¿S BASELINE ECHOCARDIOGRAM RESULTS WERE NOT PROVIDED. ON (B)(6) 2015 THE PATIENT WAS ADMITTED WITH DIZZINESS AND AN INR OF 3.5. THE PATIENT RECEIVED FRESH FROZEN PLASMA AND VITAMIN K. A CT SCAN SHOWED NO ACUTE INTRACRANIAL ABNORMALITIES; A CHRONIC POSTERIOR LEFT PARIETAL AREA OF INFARCTION WAS UNCHANGED. BLOOD CULTURES FROM (B)(6) 2015 WERE POSITIVE FOR (B)(6). THE PATIENT REPORTEDLY HAD BEEN ON AND OFF VANCOMYCIN AND DOXYCYCLINE MULTIPLE TIMES WITH LITTLE OR NO SUPPRESSIVE THERAPY NOTED. ON (B)(6) 2015 TEE SHOWED AN ENLARGED LEFT VENTRICLE WITH SEVERELY DEPRESSED LEFT VENTRICULAR SYSTOLIC FUNCTION AND AN EJECTION FRACTION OF 20-25%, BI-ATRIAL ENLARGEMENT, A SINGLE LOBED LEFT ATRIAL APPENDAGE WITH NO VISUALIZED THROMBUS AND NO EVIDENCE OF ENDOCARDITIS. ON (B)(6) 2015 THE PATIENT WAS READMITTED. CT SHOWED THREE FOCI OF ACUTE INTRAPARENCHYMAL HEMORRHAGE WITHIN THE RIGHT OCCIPITAL LOBE, LEFT CEREBELLAR HEMISPHERE AND LEFT THALAMUS. THE LARGEST HEMATOMA WAS LOCATED IN THE RIGHT OCCIPITAL LOBE WITH MODERATE SURROUNDING VASOGENIC EDEMA AND MILD MASS-EFFECT WITH EFFACEMENT OF ADJACENT SULCI WITH A 2-3MM LEFTWARD MIDLINE SHIFT. ADDITIONALLY, SUBARACHNOID ACUTE BLEEDING WAS NOTED IN MULTIPLE SULCI OVER THE RIGHT FRONTAL LOBE. THE INTRAPARENCHYMAL HEMORRHAGES WERE KNOWN PRIOR TO THIS CT FROM A SCAN PERFORMED AT AN OUTSIDE HEALTHCARE FACILITY. THE LARGE REGION OF ENCEPHALOMALACIA IN THE LEFT PARIETO-OCCIPITAL REGION LIKELY REPRESENTS SEQUELAE OF REMOTE, PRIOR ISCHEMIA. THE PATIENT¿S INR UPON ADMISSION WAS 2.4-2.5. ON 06/16/2015 CULTURES OF THE LVAD DRIVELINE EXIT SITE SHOWED NO GROWTH. ON (B)(6) 2015 THE PATIENT WAS LETHARGIC AND UNRESPONSIVE. CT SHOWED WORSENING INTRACRANIAL HEMORRHAGE WITH INCREASED MASS EFFECT WITH WORSENING RIGHTWARD MIDLINE SHIFT AND SUBFALCINE HERNIATION WITH IMPENDING TRANSTENTORIAL HERNIATION. REPORTEDLY THERE WAS NO NEUROSURGICAL OPTION AVAILABLE. THE PATIENT¿S FAMILY ELECTED TO WITHDRAW CARE AND THE PATIENT EXPIRED ON (B)(6) 2015. ALTHOUGH FULL AUTOPSY RESULTS WERE NOT PROVIDED, IT WAS REPORTED THAT ¿THE PATIENT¿S PUMP POCKET WAS FULL OF PUS AT AUTOPSY. THE (B)(6) NEVER REALLY WAS CLEARED; WHEN IT DID, IT CAME RIGHT BACK¿. A COPY OF THE AUTOPSY WAS REQUESTED BUT HAS NOT BEEN PROVIDED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512972 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death