BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4100874 · Received September 12, 2014

    Report

    Report Number
    2916596-2014-01614
    Event Type
    Injury
    Date Received
    September 12, 2014
    Date of Event
    August 9, 2014
    Report Date
    August 12, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED; THEREFORE, A CORRELATION BETWEEN THE DEVICE AND THE REPORTED STROKE COULD NOT BE CONCLUSIVELY DETERMINED. IT WAS REPORTED THAT THE VAD FUNCTIONED AS INTENDED. THE INSTRUCTIONS FOR USE LISTS STROKE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. 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 BY THE VAD COORDINATOR THAT THE PATIENT HAS A PROSTHETIC KNEE, FELL AND FRACTURED THE PROXIMAL TIBIA. WHILE IN THE HOSPITAL ON (B)(6) 2014 AT 2100, THE PATIENT'S HEART RATE INCREASED, HE WAS INCOMPREHENSIBLE AND COMBATIVE AND DEMONSTRATED SEIZURE ACTIVITY, THEN BECAME UNRESPONSIVE, RIGID, AND STOPPED BREATHING; SP02 WAS 60%. A RESPIRATORY CODE WAS INITIATED AND THE PATIENT WAS AMBU BAGGED; INTUBATION WAS NOT REQUIRED. SINCE THE EVENT, THE PATIENT REMAINS NON-INTUBATED AND IS MUMBLING INCOHERENT WORDS. THE PATIENT HAS A HISTORY OF A RIGHT MIDDLE CEREBRAL ARTERY (MCA) STROKE APPROXIMATELY 2.5 YEARS AGO AND HAS BEEN OFF ANTICOAGULANTS FOR OVER ONE YEAR DUE TO GI BLEEDING. THERE WERE NO NEW FINDINGS ON THE HEAD CT SCAN, BUT THE TEAM IS ASSUMING THE PATIENT HAD A NEW NEUROLOGICAL EVENT CAUSING THIS CHANGE IN CLINICAL STATUS. THE PATIENT'S BASELINE HAD BEEN AMBULATORY AND TALKING, BUT WITH LEFT SIDED WEAKNESS.

    Description of Event or Problem · 1

    ADDITION INFORMATION RECEIVED INDICATED THAT FOLLOWING THE LEG FRACTURE IN (B)(6) 2014, THE PATIENT WAS RESTARTED ON COUMADIN DESPITE HISTORY OF MULTIPLE GI BLEEDS. THE PATIENT WAS READMITTED ON AN UNSPECIFIED DATE FOR GI BLEEDING AND RECEIVED 6 L OF FLUID, 2 UNITS OF BLOOD, AND 2 UNITS OF FRESH FROZEN PLASMA. IT WAS REPORTED THAT THE PATIENT FAILED TO THRIVE SINCE LEG FRACTURE, EXPERIENCED A WEIGHT LOSS DOWN TO (B)(6), DEPRESSION, AND IMMOBILITY. THE PATIENT WAS MADE DNR (DO NOT RESUSCITATE) STATUS WITH COMFORT CARE MEASURES ONLY. THE PATIENT EXPIRED ON (B)(6) 2015 IN THE HOSPITAL. THE VAD COORDINATOR STATED THE VAD WAS FUNCTIONING AS EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566084 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 105353

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| R