BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 2885062 · Received December 19, 2012

    Report

    Report Number
    2916596-2012-01213
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVAL AND IS CURRENTLY BEING ANALYZED. ADDITIONAL INFO WAS RECEIVED APPROX 1 WEEK AFTER THE PUMP EXCHANGE STATING THAT THE PT HAD EXPIRED TWO DAYS AFTER THE EXCHANGE. THE HOSPITAL STAFF BELIEVES THE CAUSE OF DEATH WAS DUE TO LIVER FAILURE. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. APPROX 2 MONTHS POST-IMPLANT, THE PT AS RE-ADMITTED TO THE HOSPITAL. THE PT STATED THAT HE FELT AS IF HE WAS NOT BEING SUPPORTED BY THE DEVICE. AN ECHO WAS PERFORMED AND IT APPEARED AS IF THE PUMP AND THE OUTFLOW GRAFT WERE CLOTTED. THE PT'S PULSATILITY INDEX (PI) BEGAN TO DECREASE AND HIS PUMP POWER WAS INCREASING. A DECISION WAS MADE TO EXCHANGE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104912 114823

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention