BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3821584 · Received May 20, 2014

    Report

    Report Number
    3007042319-2014-00500
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    April 6, 2014
    Report Date
    April 25, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO A LOCAL, NON-VAD IMPLANTING, HOSPITAL WITH CONFUSION. A COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED A SMALL LEFT FRONTAL INFARCTION. IT WAS REPORTED THAT THE PATIENT WAS TRANSFERRED TO THE IMPLANTING CENTER FOR FURTHER REVIEW. TREATMENT FOR THIS EVENT WAS NOT REPORTED OTHER THAN MONITORING THE PATIENT. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED HOME FROM THE HOSPITAL. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AS IT REMAINS IMPLANTED. IT WAS LATER REPORTED TO THE MANUFACTURER AS A SEPARATE EVENT THAT THE PATIENT EXPERIENCED A MASSIVE INTRA-CRANIAL BLEED AND EXPIRED FOLLOWING ADMINISTRATION OF TISSUE PLASMINOGEN ACTIVATOR (TPA) FOR SUSPECTED PUMP THROMBOSIS. STROKE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING MEDICAL MANAGEMENT AND THERAPEUTIC ANTICOAGULATION GUIDELINES TO MINIMIZE THE RISKS. WITH REVIEW OF THE AVAILABLE INFORMATION THERE IS NO INDICATION OF ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES IMPACTING THE EVENT. ALTHOUGH A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED, CLINICAL STATUS, COMORBIDITIES, AND PHARMACOLOGICAL FACTORS ARE POSSIBLE CONTRIBUTING FACTORS. 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    APPROXIMATELY FIVE AND A HALF MONTHS AFTER THE IMPLANTATION, THE PATIENT WAS ADMITTED TO A LOCAL (NON-VAD IMPLANTING) HOSPITAL WITH CONFUSION (DISORIENTED TO PERSON AND PLACE). A COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED A SMALL LEFT FRONTAL INFARCTION. THIS EVENT WAS NOT TREATED AT THIS POINT AND APPEARS TO HAVE RESOLVED EXCEPT FOR SOME RESIDUAL CONFUSION. A FEW DAYS LATER, THE PATIENT APPEARS TO HAVE BEEN TRANSFERRED TO A VAD IMPLANTING FACILITY WHERE THE EARLIER CT WAS REVIEWED. THE PATIENT'S TREATING PHYSICIANS FELT THAT THE SIZE OF THE INFARCTION WAS VERY SMALL AND WAS OF NO REAL CONCERN. THE PATIENT WAS DISCHARGED TWO DAYS AFTER HIS ADMISSION ON MEDICATIONS THAT INCLUDED COUMADIN AND ASPIRIN (150MG).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299277 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R ASPIRIN (150MG)