BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 8663550 · Received June 3, 2019

    Report

    Report Number
    3007042319-2019-07156
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 15, 2019
    Report Date
    June 3, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707002639
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    NURSE

    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. 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 HAD A SUSPECTED GASTROINTESTINAL BLEED (GIB). THE PATIENT WAS FOUND TO HAVE A SLOW DECLINE IN HEMATOCRIT AND LOW HEMOGLOBIN, AND THE PATIENT COMPLAINED OF OCCASIONAL DIZZINESS WITH AMBULATION. STOOL GUAIAC TEST WAS POSITIVE. THE VENTRICULAR ASSIST DEVICE (VAD) REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455142 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1103 00888707002639

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other