BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3736663 · Received April 9, 2014

    Report

    Report Number
    3007042319-2014-00324
    Event Type
    Death
    Date Received
    April 9, 2014
    Date of Event
    September 13, 2013
    Report Date
    March 10, 2014
    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

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED FROM THE UNITED STATES ON (B)(6) 2013 THAT A (B)(6) MALE PATIENT WAS TRANSFERRED FROM AN OUTSIDE HOSPITAL WITH COMPLAINTS OF BODY TWITCHING ALL OVER AND A FEVER OF 101 F. IN THE ED HE WAS TACHYCARDIC AND LEUKOCYTIC BUT WAS AFEBRILE AND DENIED CHILLS OR RIGORS. HE WAS TREATED WITH ONE LITER OF NS AND IV BROAD SPECTRUM ANTIBIOTICS. HE WAS TRANSFERRED TO THE IMPLANTING HOSPITAL DUE TO A HISTORY OF A CHRONIC DRIVELINE INFECTION. BLOOD AND DRIVELINE EXIT SITE CULTURES WERE OBTAINED AND WERE POSITIVE FOR GNR. A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED EVIDENCE OF AIR CONTAINING FLUID COLLECTION ALONG THE LVAD. THERE WERE PERFUSION DEFECTS IN THE LEFT KIDNEY AND SPLEEN REFLECTING SMALL INFARCTS. THIS IS LIKELY SUGGESTIVE OF SEPTIC EMBOLI FROM A LEFT SIDED SOURCE; POSSIBLE ENDOCARDITIS OR EMBOLI FROM THE LVAD. ON (B)(6) 2013, HE WAS DISCHARGED TO HOSPICE AND SUBSEQUENTLY DIED ON (B)(6) 2013. THE DEVICE REMAINED IMPLANTED AND WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. INFECTION AND SEPSIS ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING PRE AND POST-OPERATIVE INFECTION CONTROL MEASURES AND DRIVELINE CARE. WITH REVIEW OF THE AVAILABLE INFORMATION, A RELATIONSHIP BETWEEN THE DEVICE AND REPORTED EVENT CANNOT BE DETERMINED. CLINICAL FACTORS INCLUDING PATIENT'S MEDICAL CONDITION AND COMORBIDITIES MAY HAVE CONTRIBUTED; THERE IS NO INDICATION THAT IT IS RELATED TO ANY DEVICE MANUFACTURING OR PERFORMANCE ISSUES. 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.

    Description of Event or Problem · 1

    APPROXIMATELY TWO YEARS AND NINE MONTHS POST HVAD IMPLANTATION, THE PATIENT EXPIRED FOLLOWING HOSPITAL ADMISSION FOR SEPSIS, SECONDARY TO GRAM NEGATIVE BACTEREMIA IN THE SETTING OF CHRONIC LVAD INFECTION AND FEVER. MANAGEMENT HAD BEEN COMPLICATED BY PATIENT NONCOMPLIANCE. THE PATIENT HAD PRESENTED TO THE ED WITH COMPLAINTS OF TWITCHING AND RECENT HISTORY OF FEVERS AND WAS NOTED TO BE TACHYCARDIC BUT AFEBRILE. THE PATIENT WAS INITIALLY TREATED WITH IV FLUIDS AND IV ANTIBIOTICS BUT WAS LATER DISCHARGED TO (B)(6) WHERE HE EXPIRED AFTER FIVE WEEKS. NO AUTOPSY WAS PERFORMED AND THE DEVICE REMAINED IMPLANTED IN THE PATIENT POST-MORTEM. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216082 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Death GENTAMICIN| CIPROFLOXACIN