BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4962707 · Received August 4, 2015

    Report

    Report Number
    2916596-2015-01406
    Event Type
    Injury
    Date Received
    August 4, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 6, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S WEIGHT WAS NOT PROVIDED. INFORMATION IS UNKNOWN AS THE IMPLANT DATE AND SERIAL NUMBER OF THE DEVICE WAS REQUESTED BUT NOT PROVIDED. THE EXPLANTED DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. IT HAS NOT YET BEEN RECEIVED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS INITIALLY REPORTED THAT THE DEVICE WAS RETURNING FOR ANALYSIS; HOWEVER, THE DEVICE WAS NOT RETURNED. APPROXIMATE AGE OF DEVICE ¿ 14 DAYS. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED AS THE PRODUCT WAS NOT RETURNED FOR EVALUATION. INFECTION AND SEPSIS ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE INFECTIOUS PROCESS WAS NOT RELATED TO THE OPERATIVE PROCEDURE. THE PATIENT WAS ON EXTRACORPOREAL CIRCULATORY SUPPORT PRE-OPERATIVELY IN AN ATTEMPT TO CLEAR THE INFECTION PRE-PUMP IMPLANT. THE PATIENT WAS INITIALLY PLACED ON DIALYSIS AND REQUIRED CONTINUOUS RENAL REPLACEMENT THERAPY DUE TO HYPOTENSION AND INSTABILITY. PRIOR TO LVAD IMPLANT, THE PATIENT WAS LEVEL INTERMACS II AND CONSIDERED A VERY HIGH RISK IMPLANT DUE TO PREOPERATIVE PRESENTATION OF SEPTIC AND CARDIOGENIC SHOCK. POSITIVE CULTURES INCLUDED AN ABSCESS CULTURE FROM BILATERAL LEG ULCERS, POSITIVE ENTEROBACTER FROM NON-LACTOSE FERMENTING GRAM NEGATIVE RODS, AND GRAM POSITIVE COCCI. ANTIBIOTIC THERAPY WAS PERFORMED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT¿S WHITE BLOOD CELL COUNT WAS ELEVATED TO 60,000 CELLS/UL BUT A SOURCE OF INFECTION COULD NOT BE IDENTIFIED. THE ELEVATED WHITE BLOOD CELL COUNT WAS ASSUMED TO BE RELATED TO AN OVERWHELMING FUNGAL INFECTION THAT HAD NOT DECLARED ITSELF. THE PATIENT EXPIRED DUE TO SEPSIS ON (B)(6) 2015. AN AUTOPSY WOULD BE PERFORMED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506998 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention