BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4162697 · Received October 7, 2014

    Report

    Report Number
    2916596-2014-01803
    Event Type
    Injury
    Date Received
    October 7, 2014
    Date of Event
    September 7, 2014
    Report Date
    September 10, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT CONTINUES ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED GI BLEEDING COULD NOT BE DETERMINED. THE PATIENT REMAINS ONGOING ON LVAD SUPPORT AND NO FURTHER RELATED EVENTS HAVE BEEN REPORTED. BASED ON THE INFORMATION AVAILABLE TO THE MANUFACTURER, NO CONCLUSION COULD BE DRAWN AS TO THE ROOT CAUSE OF THE REPORTED EVENT. THE DEVICE¿S APPROVED LABELING LISTS BLEEDING AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE LEFT VENTRICULAR ASSIST SYSTEM (LVAS). A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE PUMP MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PT WAS READMITTED ON (B)(6) 2014 DUE TO HGB 5.4 AND FATIGUE. NO ALARMS WERE REPORTED FOR THIS EVENT. THE PT WAS TRANSFUSED AND WILL BE MEDICALLY MANAGED AT THIS POINT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT, APPROXIMATELY 3 AND HALF MONTHS AFTER THE INITIAL EVENT, THE PATIENT WAS RE-ADMITTED AGAIN DUE TO ANOTHER EPISODE OF GASTROINTESTINAL (GI) BLEEDING. THE PATIENT RECEIVED A BLOOD TRANSFUSION AND WAS DISCHARGED TWO DAYS LATER. WILL CONTINUE TO BE MEDICALLY MANAGED ON OCTREOTIDE THERAPY AS AN OUTPATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    629991 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 126613

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention