BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3042034 · Received April 4, 2013

    Report

    Report Number
    2916596-2013-00370
    Event Type
    Death
    Date Received
    April 4, 2013
    Date of Event
    January 13, 2013
    Report Date
    March 8, 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

    ADDITIONAL INFORMATION BASED ON THE INFORMATION AVAILABLE TO THE MANUFACTURER, A CORRELATION TO THE DEVICE COULD NOT CONCLUSIVELY BE DETERMINED. THE PRODUCT WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. HOWEVER STROKE AND INFECTION ARE LISTED IN THE DEVICE¿S APPROVED LABELING AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT. 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

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT EXPIRED DUE TO COMPLICATIONS FROM A CEREBRAL HEMORRHAGE. THE PT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS 2.4 AT THE TIME OF THE EVENT. IT WAS REPORTED THAT THE PT ALSO HAD A DRIVELINE INFECTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION PROVIDED INDICATED THAT THE PATIENT EXPIRED ON (B)(6), 2013 AFTER VENTRICULAR TACHYCARDIA (VTACH) ARREST AND OVER 30 MINUTES OF ADVANCED CARDIOVASCULAR LIFE SUPPORT (ACLS). AFTER REVIEW OF THE PATIENT¿S RECORD, IT WAS NOTED THAT THE PATIENT DID NOT EXPIRE DUE TO CEREBRAL HEMORRHAGE. IT WAS ALSO NOTED THAT THE EVENT WAS NOT PUMP RELATED AND THAT THE PUMP FUNCTIONED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137689 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 107664

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death