BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6178572 · Received December 15, 2016

    Report

    Report Number
    3007042319-2016-04437
    Event Type
    Injury
    Date Received
    December 15, 2016
    Date of Event
    April 13, 2016
    Report Date
    December 7, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. THE SYSTEM IS INDICATED FOR USE UNDER THE DIRECT SUPERVISION OF A LICENSED PRACTITIONER OR BY PERSONNEL TRAINED IN ITS' PROPER USE. THESE PROFESSIONALS SHOULD BE AWARE OF THE PHYSICAL AND PSYCHOLOGICAL NEEDS OF PATIENTS UNDERGOING LVAD SUPPORT. CLINICAL RESULTS AND COMMERCIAL EXPERIENCE DEMONSTRATE THAT THE PLACEMENT OF A VAD IN CHRONIC NYHA CLASS IV PATIENTS IMPROVES SURVIVAL AND QUALITY OF LIFE WHEN COMPARED TO A SIMILAR PATIENT POPULATION RECEIVING CONVENTIONAL THERAPY. SEPSIS AND DRIVELINE AND WOUND INFECTIONS ARE POTENTIAL COMPLICATIONS THAT MAY BE ASSOCIATED WITH USE OF THE PRODUCT. THE INSTRUCTIONS FOR USE (IFU) PROVIDES GUIDELINES TO REDUCE THE OCCURRENCE AND SEVERITY OF INFECTION. THOSE WITH COMPROMISED IMMUNE SYSTEMS AND/OR TREATED WITH MULTIPLE ANTIBIOTICS ARE MORE SUSCEPTIBLE TO THESE TYPES OF INFECTIONS. OTHER CONTRIBUTING FACTORS ALSO INCLUDE THE PATIENT'S BODY TYPE AND NUTRITIONAL STATUS, PLACEMENT, POSITION AND SIZE OF THE VAD, TENSION/ TRAUMA TO THE DRIVELINE EXIT SITE, DURATION OF TIME ON VAD SUPPORT AND HISTORY OF RECURRENT POLYMICROBIAL INFECTIONS. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE CLINICAL DATA SITE THAT ON (B)(6) 2016 THE PATIENT WAS DIAGNOSED WITH UNKNOWN INFECTION. IT WAS STATED THAT IT WAS POSSIBLY SEPSIS PER CLINICAL PICTURE. IT WAS STATED THAT THE PATIENT RECEIVED DRUG THERAPY INTRAVENOUSLY (IV). ON (B)(6) 2016 THE PATIENT WAS RE-HOSPITALIZED FOR PRIMARY REASON OF HAVING NEPHROSTOMY TUBE EXCHANGE. THE CLINICAL DATA SITE STATED THAT THIS EVENT WAS NOT DEVICE RELATED. THE PATIENT WAS STATED TO HAVE BEEN DISCHARGED ON (B)(6) 2016. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827543 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R