BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6157654 · Received December 9, 2016

    Report

    Report Number
    3007042319-2016-04363
    Event Type
    Injury
    Date Received
    December 9, 2016
    Date of Event
    August 28, 2016
    Report Date
    November 18, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    STROKE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS. WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE EVENT. THERE IS ALSO NO CLINICAL EVIDENCE TO SUGGEST THAT A MALFUNCTION OF THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THOUGH THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED; CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED ARE MULTIFACTORIAL AND MAY BE ATTRIBUTED TO MEDICAL TREATMENT, PROGRESSION OF DISEASE, AND PATIENT COMORBIDITIES. THOUGH THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED THERE ARE PATIENT FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. 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, INCLUDING TRANSPORTATION. STROKE IS A KNOWN POTENTIAL CLINICAL ADVERSE EVENT ASSOCIATED WITH VADS AS OUTLINED IN THE IFU. THE INSTRUCTIONS FOR USE (IFU) AND PATIENT MANUAL CONTAINS STROKE AND NEUROLOGIC DYSFUNCTION AS POTENTIAL EVENTS THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. THE IFU PROVIDES ANTICOAGULATION GUIDELINES TO REDUCE THE OCCURRENCE AND SEVERITY OF STROKES. THE SYSTEM IS CONTRAINDICATED IN PATIENTS WHO CANNOT TOLERATE ANTICOAGULATION THERAPY TO REDUCE THE POSSIBILITY OF STROKE. MOREOVER, THE IFU FURTHER EDUCATES THE USER ON PUMP OPERATION AND FLOW GUIDELINES IN ORDER TO DECREASE THE RISK OF A STROKE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. IT IS UNKNOWN WHICH OF THESE WERE INVOLVED IN THE EVENT. THE DEVICES REMAIN IMPLANTED , THEREFORE WILL NOT BE RETURNED. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED: THE PATIENT DID NOT RECEIVE ANY TREATMENT ONLY INPATIENT OBSERVATION. THE PATIENT IS NOW STABLE, DISCHARGED, AND FULLY RECOVERED. 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 THIS PATIENT WAS ADMITTED TO AN OUTSIDE HOSPITAL WITH COMPLAINTS OF ACUTE LEFT SIDED WEAKNESS, FACIAL DROOP AND DYSARTHRIA. SYMPTOMS IMPROVED SPONTANEOUSLY; HOWEVER, THERE WAS RESIDUAL WEAKNESS ON THE MORNING OF TRANSFER TO THE IMPLANTING FACILITY. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) ON PRESENTATION WAS 3.3. COMPUTED TOMOGRAPHY (CT) SCAN RESULTS WERE SUGGESTIVE OF INFARCTS OF AN EMBOLIC ETIOLOGY THOUGH ECHOCARDIOGRAM RESULTS DID NOT INDICATE THAT THE SOURCE OF THE EMBOLI WERE CARDIAC IN NATURE.  DEVICE INTERROGATION PERFORMED BY THE SITE INDICATED THAT THERE WERE NO ISSUES DURING THE EVENTS AT TIME OF REPORTED SYMPTOMS.  THE PATIENT WAS DISCHARGED ON (B)(6) 2016 WITH AN INTERNATIONAL NORMALIZED RATIO (INR) OF 2.6 AND NO RESIDUAL NEUROLOGICAL DEFICIT.  HE CONTINUED ON WARFARIN AND TICAGRELOR FOR ANTICOAGULATION THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810275 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L| R