BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5106602 · Received September 26, 2015

    Report

    Report Number
    3007042319-2015-02300
    Event Type
    Death
    Date Received
    September 26, 2015
    Date of Event
    August 20, 2015
    Report Date
    September 14, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE PATIENT EXPERIENCED A STERNAL ABSCESS POST-OPERATIVELY. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    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 HEARTWARE® 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 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. LOCAL INFECTION AND SEPSIS ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS. THE HEARTWARE® INSTRUCTIONS FOR USE (IFU) ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING PRE AND POST-OPERATIVE INFECTION CONTROL MEASURES AND DRIVELINE CARE. 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 FROM (B)(6) THAT THIS PATIENT SUFFERED CARDIAC DECOMPENSATION FOUR DAYS POST TEETH EXTRACTIONS REQUIRING HVAD IMPLANTATION ON (B)(6) 2015. THE PATIENT REMAINED IN THE INTENSIVE CARE UNIT AS A RESULT OF MULTIPLE COMPLICATIONS INCLUDING THROMBOCYTOPENIA, RENAL FAILURE REQUIRING HEMODIALYSIS, AND "SUSPECTED" MEDIASTINITIS REQUIRING THE ADMINISTRATION OF "HIGH DOSE CATECHOLAMINES" AND "RESPIRATORY THERAPY VIA DILATATIVE TRACHEOSTOMY". CATHETERS WERE CHANGED ROUTINELY TO PREVENT INFECTION. THE STERNUM DID NOT HEAL DESPITE CONTINUED VAC THERAPY AND THE PATIENT WAS UNABLE TO BE WEANED FROM THE VENTILATOR AND INOTROPIC THERAPY. THE PATIENT SUBSEQUENTLY DEVELOPED VENTRICULAR TACHYCARDIA REQUIRING INTRAVENOUS AMIODARONE AND LIDOCAINE. ON (B)(6) 2015 THE PATIENT BEGAN TO DECLINE NEUROLOGICALLY EVENTUALLY DEVELOPING MULTI-ORGAN FAILURE. THE PATIENT EXPIRED ON (B)(6) 2015 AT 05:33.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    637316 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death