BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3001615 · Received March 11, 2013

    Report

    Report Number
    2916596-2013-00249
    Event Type
    Injury
    Date Received
    March 11, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 10, 2013
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP AND IS REPORTED TO BE RECOVERING WELL AND HAD ALREADY BEEN EXTUBATED. THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO 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. AT THE TIME OF THE IMPLANTATION, THE PT WAS REPORTED TO HAVE HAD LOW PLATELETS AND WAS TREATED AS A HEPARIN-INDUCED THROMBOCYTOPENIA (HIT II) PT. THEREFORE, DURING THE IMPLANTATION, ARGATROBAN WAS USED INSTEAD OF HEPARIN, AND THE IMPLANTATION TOOK PLACE WHILE THE PT WAS ON ECMO SUPPORT WITHOUT A HEART-LUNG MACHINE. THE PT RECOVERED WELL AFTER THE IMPLANTATION AND HE WAS EXTUBATED SOON AFTER. APPROX 10 DAYS POST-IMPLANT, THE PERFUSIONIST NOTICED POWER ELEVATIONS UP TO 10 WATTS. AN ECHO REVEALED A DILATED LEFT VENTRICLE (LV) AND CONTINUOUS OPENING OF THE AORTIC VALVE. A RAMP TEST WAS CONDUCTED WITHOUT EFFECT. THE LV-ANGIO AND CARDIO CT SHOWED NO CONTRAST IN THE OUTFLOW GRAFT. A DECISION WAS MADE TO EXCHANGE THE PUMP THE FOLLOWING DAY. THE IMPLANTING SURGEON HAD MENTIONED THAT ONE DAY PRIOR, THE PT HAD LOW FLOWS AND ALSO THAT THE ANTICOAGULATION LEVEL WAS ON THE LOW END (PTT <40 SEC ON ARGATROBAN) AND MAY HAVE BEEN THE ROOT CAUSE OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101947 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104912

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention