BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3032469 · Received March 29, 2013

    Report

    Report Number
    2916596-2013-00345
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 1, 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 PUMP REMAINS IN USE SUPPORTING THE PT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION 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 COORDINATOR THAT THE PT HAD EXPERIENCED SOME RIGHT HEART FAILURE SYMPTOMS PRIOR TO LEAVING THE OPERATING ROOM. SOME OF THE SIGNS WERE INCREASING CENTRAL VENOUS PRESSURE (CVP) BUT SYSTOLIC PULMONARY ARTERIAL PRESSURE REMAINED IN THE 30'S. ACCORDING TO THE SURGEON, THE ECHO SHOWED THAT THE RIGHT VENTRICLE WAS NOT CONTRACTING A GREAT DEAL. NITRIC OXIDE WAS STARTED IN THE OPERATING ROOM ALONG WITH MILRINONE. SIX DAYS LATER, THE PT WAS NO LONGER ON INOTROPES; HOWEVER, HIS CREATININE WAS STILL ELEVATED AND HE WAS HAVING CHALLENGES WITH DIURETICS. THE HOSPITAL STAFF MONITORED THE PT WITH AN ECHO OF THE RIGHT VENTRICLE AND WATCHED KIDNEY FUNCTION, SPECIFICALLY CREATININE. A FEW DAYS LATER, THE PT'S CREATININE DECREASED AND WAS IMPROVING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130716 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 123663

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention