BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 2932243 · Received January 25, 2013

    Report

    Report Number
    2916596-2013-00105
    Event Type
    Injury
    Date Received
    January 25, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 3, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS SUCCESSFULLY TRANSPLANTED ON (B)(6) 2013. THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION 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. APPROXIMATELY 3 MONTHS POST-IMPLANT, THE HEART FAILURE CARDIOLOGIST REPORTED THAT THE PT HAD INCREASED HEART FAILURE SYMPTOMS AND HEMOLYSIS. A RAMP STUDY WAS CONDUCTED AND THE PUMP SPEED WAS INCREASED TO GREATER THAN 11,000 RPM'S. THE RESULTS INDICATED THAT THE AORTIC VALVE (AV) WAS OPENING WITH EVERY BEAT. A DECISION WAS MADE TO PLACE THE PT ON THE HIGH URGENT TRANSPLANT LIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36077 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106016 117629

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention