BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3113550 · Received May 10, 2013

    Report

    Report Number
    2916596-2013-00540
    Event Type
    Death
    Date Received
    May 10, 2013
    Date of Event
    January 4, 2013
    Report Date
    April 11, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AVAILABLE TO THE MANUFACTURER, THE REPORT OF INFECTION AND HEMOLYSIS COULD NOT BE CONFIRMED, AND A CORRELATION TO THE DEVICE COULD NOT CONCLUSIVELY BE DETERMINED. THE DEVICE'S APPROVED LABELING LISTS INFECTION (LOCAL, DRIVELINE, POCKET) AND HEMOLYSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE LEFT VENTRICULAR ASSIST SYSTEM (LVAS). PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    THE PUMP WILL NOT BE RETURNING TO THE MFR FOR ANALYSIS AS IT WAS NOT EXPLANTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: THE PATIENT REPORTEDLY DEVELOPED AN UNSPECIFIED INFECTION THAT WAS NOT RESOLVED WITH ANTIBIOTICS, LEADING TO MULTISYSTEM ORGAN FAILURE. THE VAD COORDINATOR DID NOT BELIEVE THE EVENT WAS RELATED TO THE DEVICE AS THERE WERE NO CHANGES IN PUMP PARAMETERS. THE PATIENT ALSO REQUIRED RIGHT VENTRICULAR ACUTE SUPPORT WHICH WAS NEVER ABLE TO BE WEANED. THE PATIENT HAD DEVELOPED HEMOLYSIS; HOWEVER IT HAD BEEN TRENDING DOWN PRIOR TO PATIENT EXPIRATION. AN AUTOPSY WAS NOT PERFORMED AND THE PUMP WAS REPORTEDLY NOT AVAILABLE TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT HAD AN INFECTION, WAS TREATED WITH ANTIBIOTICS, AND THEN EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207610 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 119464

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Death