BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 8841700 · Received July 30, 2019

    Report

    Report Number
    3007042319-2019-08769
    Event Type
    Death
    Date Received
    July 30, 2019
    Report Date
    July 30, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    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 AND DESTINATION THERAPY 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. PRODUCT EVENT SUMMARY: THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.  WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENTS. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE.  THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THIS EVENT WAS REPORTED IN THE Q1 2019 INTERMACS DATA REGISTRY THAT TRACKS CLINICAL OUTCOMES OF PATIENTS ON VENTRICULAR ASSIST DEVICE (VAD) SUPPORT. THE DATA REGISTRY DOES NOT CONTAIN DEVICE IDENTIFYING INFORMATION OR EVENT DATE AND THEREFORE CANNOT BE CORRELATED TO ANY PREVIOUSLY RECEIVED REPORT OF THE EVENT. BASED ON THE PROVIDED DATA, DEVICE ANALYSIS WILL NOT BE POSSIBLE AND NO FURTHER INFORMATION WILL LIKELY BE MADE AVAILABLE CONCERNING THE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO UNSPECIFIED MAJOR BLEEDING. THE VENTRICULAR ASSIST DEVICE (VAD) REMAINS IN THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED REGARDING THIS EVENT. THIS EVENT WAS REPORTED IN THE Q1 2019 INTERMACS DATA REGISTRY THAT TRACKS CLINICAL OUTCOMES OF PATIENTS ON VENTRICULAR ASSIST DEVICE (VAD) SUPPORT. THE DATA REGISTRY DOES NOT CONTAIN DEVICE IDENTIFYING INFORMATION OR EVENT DATE AND THEREFORE CANNOT BE CORRELATED TO ANY PREVIOUSLY RECEIVED REPORT OF THE EVENT. BASED ON THE PROVIDED DATA, DEVICE ANALYSIS WILL NOT BE POSSIBLE AND NO FURTHER INFORMATION WILL LIKELY BE MADE AVAILABLE CONCERNING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636212 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death