BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6052469 · Received October 24, 2016

    Report

    Report Number
    3007042319-2016-03731
    Event Type
    Injury
    Date Received
    October 24, 2016
    Date of Event
    September 22, 2016
    Report Date
    September 28, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. THE LVAD SYSTEM IS DESIGNED TO ASSIST A WEAKENED, POORLY FUNCTIONING LEFT VENTRICLE. THE IMPLANTATION OF A VAD IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. THESE SURGICAL PROCEDURES ARE ASSOCIATED WITH NUMEROUS RISKS. SERIOUS AND LIFE THREATENING ADVERSE EVENTS, INCLUDING STROKE, HAVE BEEN ASSOCIATED WITH THE USE OF THIS DEVICE. A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. INTRACEREBRAL BLEEDING IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING MEDICAL MANAGEMENT AND THERAPEUTIC ANTICOAGULATION GUIDELINES TO MINIMIZE THE RISKS. WITH A REVIEW OF THE AVAILABLE INFORMATION THERE WAS NO EVIDENCE OF DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES OF THE DEVICE THAT WOULD IMPACT THE REPORTED EVENT. COAGULOPATHIES LEADING TO INTRACEREBRAL HEMORRHAGE CAN BE CAUSED BY OVERUSE OF ANTICOAGULANT THERAPY AND UNCONTROLLED BLOOD PRESSURE. PATIENT'S WITH CERTAIN RISK-FACTORS SUCH AS, SMOKING, CARDIOVASCULAR DISEASE AND HYPERTENSION MAY ALSO HAVE AN INCREASED LIKELIHOOD OF STROKE OCCURRENCE. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED INCLUDE ANTICOAGULATION THERAPY, RELATED COMORBIDITIES, AND THE PATIENT'S PAST MEDICAL HISTORY. THOUGH THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED THERE ARE PATIENT, PROCEDURAL, AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS A BLANK, UNKNOWN AND AS NO INFORMATION (NI), THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE MECHANICAL CIRCULATORY SUPPORT (MCS) MANAGER THAT THE PATIENT HAD ALTERED MENTAL STATUS AND HALLUCINATIONS WITH WORSENING OF NEUROLOGICAL EXAM ON (B)(6) 2016. URGENT COMPUTED TOMOGRAPHY (CT) SCAN OF THE HEAD DEMONSTRATED A LARGE FRONTAL LOBE INTRAPARENCHYMAL HEMORRHAGE (IPH) WITH LEFT TO RIGHT MIDLINE SHIFT. HEPARIN DRIP WAS STOPPED AND PATIENT WAS GIVEN 50 MG OF PROTAMINE SULFATE AND TWO UNITS OF PLATELETS. PATIENT WAS TAKEN TO OPERATING ROOM (OR) FOR EMERGENT HEMATOMA EVACUATION. PATIENT UNDERWENT LEFT HEMICRANIECTOMY FOR LEFT FRONTAL CLOT EVACUATION. IT WAS STATED THAT IT WAS PARTICULARLY CHALLENGING TO OBTAIN HOMEOSTASIS IN THE MORNING OF (B)(6) 2016, THE PATIENT OPENED EYES TO VOICE, MOVED ALL EXTREMITIES (MAE), AND WAS FOLLOWING COMMANDS. POST-OP HEAD CT SCAN REVEALED NO EVIDENCE OF RE-ACCUMULATION OF BLOOD. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703684 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L| R