BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3082300 · Received April 4, 2013

    Report

    Report Number
    2916596-2013-00382
    Event Type
    Injury
    Date Received
    April 4, 2013
    Date of Event
    March 7, 2013
    Report Date
    March 10, 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

    THE USER FACILITY REPORT ((B)(4)) WAS RECEIVED FROM THE INTERMACS REGISTRY. THE DEVICE WAS RETURNED TO THE MFR, AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE T 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). IT WAS REPORTED BY THE VAD COORD THAT THE PT EXPERIENCED A LOW PULSATILITY INDEX (PI) OF APPROX 1.6 LONG WITH ELEVATED POWERS REACHING BETWEEN 8 AND 9 WATTS. THE PT WAS INSTRUCTED TO HYDRATE HIMSELF AND TO MONITOR IT OVERNIGHT. THE FOLLOWING MORNING THE PT PUMP PARAMETERS HAD NOT CHANGED MUCH SO HE WAS BROUGHT TO THE CLINIC WHERE INTERROGATION SHOWED POWERS FROM 10-13 WATTS. THE PT WAS ADMITTED INTO THE HOSPITAL THAT AFTERNOON. AN ECHO WAS PERFORMED; HOWEVER, NOTHING ABNORMAL WAS NOTED. HEPARIN WAS STARTED. THE PT UNDERWENT A COMPUTED TOMOGRAPHY (CT) ANGIO, BUT THIS WAS ALSO NEGATIVE FOR PULMONARY EMBOLISM (PE) AND INFLOW/OUTFLOW GRAFT CLOT. THE PT WAS STARTED ON MILRINONE 0.33 MCG. THAT EVENING, THE PT'S PUMP ALARMED BRIEFLY AND ON INTERROGATION, IT WAS NOTED THAT THE PUMP STOPPED FOR A FEW SECONDS. THE PT WAS ASYMPTOMATIC. THE PT WAS ELEVATED TO STATUS 1A ON THE HEART TRANSPLANT LIST FOR DEVICE MALFUNCTION AND THE PUMP SPEED WAS INCREASED TO 8800 RPM. A KIDNEY URETER AND BLADDER (KUB) X-RAY WAS TAKEN TO ASSESS THE DRIVELINE, BUT NO FRACTURES WERE NOTED. A DECISION WAS MADE TO EXCHANGE THE PT'S PUMP. ADDITIONAL INFO WAS RECEIVED INDICATING THAT THE PT'S PUMP WAS EXCHANGED 5 DAYS LATER. THE PT REMAINS ONGOING WITH THE NEW LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137819 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 105453

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention