BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 4788937 · Received May 21, 2015

    Report

    Report Number
    3007042319-2015-00911
    Event Type
    Injury
    Date Received
    May 21, 2015
    Date of Event
    February 10, 2015
    Report Date
    April 22, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF VENTRICULAR ASSIST SYSTEMS, OTHER THAN DEATH, INCLUDE BLEEDING, NEUROLOGICAL DYSFUNCTION AND STROKE. HEARTWARE 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 BLANK, UNKNOWN AND AS NO INFORMATION (NI). THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AT THE TIME OF THE SUBMISSION OF THIS REPORT. THE MANUFACTURER IS SEEKING THIS INFORMATION THROUGH THE INVESTIGATION OF THIS EVENT. THE PUMP REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE DEVICE REMAINS IMPLANTED AND WILL NOT BE RETURNED TO THE MANUFACTURER FOR EVALUATION. PATIENT RECEIVED TREATMENT AND WAS DISCHARGED HOME. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. WITH REVIEW OF THE AVAILABLE CLINICAL DATA AND THE DEVICE HISTORY RECORDS, THERE IS NO INDICATION OF ANY DEVICE MANUFACTURING OR PERFORMANCE ISSUES RELATED TO THE REPORTED EVENT. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED 'CLINICAL ADVERSE EVENT' CANNOT BE CONCLUSIVELY DETERMINED. 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. STROKE/NEUROLOGICAL DYSFUNCTION IS A KNOWN POTENTIAL CLINICAL ADVERSE EVENT ASSOCIATED WITH VADS AS OUTLINED IN THE IFU. INVESTIGATIONS OF COMPLAINTS WITH SIMILAR CIRCUMSTANCES WERE REVIEWED; EVENTS OF THESE TYPES ARE MULTIFACTORIAL AND MAY BE ATTRIBUTED TO PRE-EXISTING CONDITIONS AND PROGRESSION OF THESE DISEASES, THE HVAD SYSTEM, THE IMPLANT PROCEDURE, OR CONCOMITANT THERAPY. 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 THAT ON (B)(6) 2015 THE PATIENT CALLED (VAD) COORDINATOR COMPLAINING OF DIZZINESS, WEIRD VISION (COULDN'T SEE STRAIGHT), HEADACHE IN THE EARLY AM AND SLEPT ALL DAY. THE PATIENT CAME TO THE FACILITY AROUND 5PM WITH THE SAME SYMPTOMS, AND WAS ADMITTED. A STAT CT W/O SHOWED A HYPO-DENSITY IN LEFT THALAMUS, WHICH WAS NOT CONFIRMED AS A CVA, AND IT WAS NOTED THAT THE DENSITY MAY REPRESENT LACUNAR INFARCT OF UNKNOWN AGE. ANOTHER CT WAS DONE WITH CONTRAST WHICH SHOWED NO EVIDENCE OF A LESION. THE PATIENT WAS VOLUME DEPLETED, WAS TREATED WITH IV FLUIDS, AND HIS PHYSICIAN PLANNED ANOTHER PLASMAPHERESIS TREATMENT FOR HIGH PANEL REACTIVE ANTIBODIES (PRA), ALONG WITH 3 CYCLES OF BENZTROPINE (BZT) DESENSITIZATION (THE 4TH CYCLE WAS HELD DUE TO THE PATIENT DEVELOPING PANCYTOPENIA). PATIENT IS TAKING 325MG ASA AND COUMADIN DAILY, THE INR IS REPORTED TO BE WITHIN THERAPEUTIC RANGE. TWO UNITS PACKED RED BLOOD CELLS WERE TRANSFUSED DURING THIS ADMISSION BECAUSE THE PATIENT'S HGB & HCT WAS LOW SECONDARY TO "A MAJOR BLEED". COUMADIN WAS STOPPED DURING THIS ADMISSION AND THE PATIENT WAS BRIDGED WITH HEPARIN. DISCHARGED FROM THE FACILITY ON (B)(6) 2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330932 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Hospitalization