BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3944891 · Received July 18, 2014

    Report

    Report Number
    3007042319-2014-00737
    Event Type
    Death
    Date Received
    July 18, 2014
    Date of Event
    June 28, 2014
    Report Date
    July 8, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    HVAD® PUMP HW20925 WAS RETURNED TO HEARTWARE FOR EVALUATION. POST-EXPLANT ENGINEERING ANALYSIS DID NOT REVEAL ANY CONDITIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. EVIDENCE COLLECTED THROUGH FAILURE ANALYSIS INVESTIGATION DID NOT IDENTIFY MANUFACTURING, DIMENSIONAL, OR FUNCTIONAL ANOMALIES THAT MAY HAVE COMPROMISED SAFETY OR PERFORMANCE OF THIS DEVICE. REVIEW OF THE CONTROLLER LOG FILES CONFIRMED POWER CONSUMPTION AND ESTIMATED FLOW OUTSIDE THE NORMAL OPERATING RANGE, CORRELATING WITH THE REPORTED EVENT. INDEPENDENT PATHOLOGICAL ANALYSIS CONFIRMED THE PRESENCE OF THROMBUS; THE CAUSE AND ORIGIN OF THE THROMBUS CANNOT BE CONCLUSIVELY DETERMINED. THE REPORTED EVENT IS RELATED TO USE OF THE DEVICE. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE EVENT ARE UNKNOWN. WHILE THE CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED, THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED 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. INVESTIGATIONS OF COMPLAINTS WITH SIMILAR CIRCUMSTANCES WERE CONSIDERED; AN INCREASE IN POWER MAY BE DUE TO PUMP THROMBUS/THROMBOSIS, WHICH IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AND IS MULTIFACTORIAL IN ETIOLOGY. RISK DOCUMENTATION INDICATES THAT FORMATION OF THROMBUS WITHIN THE PUMP MAY LIMIT THE PERFORMANCE OF THE DEVICE AND MAY TRIGGER AN ALARM DUE TO HIGH POWER CONSUMPTION

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR EVALUATION, BUT HAS NOT BEEN RECEIVED BY THE MANUFACTURER. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. PRODUCT IS IN ROUTE.

    Description of Event or Problem · 1

    APPROXIMATELY THREE AND A HALF WEEKS AFTER IMPLANT THIS PATIENT DEVELOPED HIGH WATTS AND, DESPITE REPEATED THROMBOLYSIS, DIED SIX DAYS LATER DUE TO BOWEL ISCHEMIA. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421926 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Death