BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3011143 · Received March 15, 2013

    Report

    Report Number
    2916596-2013-00281
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 18, 2013
    Report Date
    February 19, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 (LVAD). THE VAD COORDINATOR REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PT WAS STABLE AND THE SURGEONS WERE BEGINNING TO CLOSE THE CHEST. IT WAS REPORTED THAT THE PT SUDDENLY BECAME HYPOTENSIVE AND THE PUMP POWER SPIKED. THE SURGEONS LOOKED INSIDE THE OUTFLOW GRAFT AS WELL AS THE PUMP ITSELF AND NOTICED THAT THEY BOTH CONTAINED CLOTS. THE SURGEONS DECIDED TO EXCHANGE THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110085 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 123431

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention