BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6037730 · Received October 18, 2016

    Report

    Report Number
    3007042319-2016-03643
    Event Type
    Injury
    Date Received
    October 18, 2016
    Date of Event
    June 6, 2016
    Report Date
    September 21, 2016
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WITH REVIEW OF THE AVAILABLE INFORMATION NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES OF THE DEVICE THAT WOULD IMPACT THE REPORTED EVENT. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT MAY BE RELATED TO THE DEVICE-REQUIRED ANTICOAGULANT THERAPY. THOUGH THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED THERE ARE PATIENT AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. 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. GASTROINTESTINAL BLEEDING HAS BEEN IDENTIFIED AS A KNOWN POTENTIAL RISK ASSOCIATED WITH USE OF ALL VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). KNOWN CONTRIBUTING FACTORS TO GI BLEEDING INCLUDE INDIVIDUAL PATIENT COMORBIDITIES AND PHARMACOLOGICAL FACTORS. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT, INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE SITE BY THE CLINICAL ENGINEER THAT THE PATIENT CALLED TO REPORT EXPERIENCING LOW FLOW ALARMS AT HOME AND COMPLAINED OF MELENA. THE PATIENT WAS INSTRUCTED TO COME TO THE EMERGENCY DEPARTMENT (ED) FOR FURTHER EVALUATION. PATIENT WAS STATED TO HAVE BEEN ADMITTED ON (B)(6) 2016. STOOL CULTURES WERE POSITIVE FOR OCCULT BLOOD, NO TRANSFUSIONS GIVEN, AS PATIENT IS BRIDGE TO TRANSPLANT (BTT) AND THE SITE WANTS TO LIMIT ANTIBODY EXPOSURE. GASTROINTESTINAL (GI) TEAM CONSULTED BUT DETERMINED THAT SINCE HEMOGLOBIN HAD STABILIZED, NO INTERVENTIONS NECESSARY. PATIENT WAS DISCHARGED HOME ON (B)(6) 2016. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688242 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| L| O| R