BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3951916 · Received July 7, 2014

    Report

    Report Number
    2916596-2014-00983
    Event Type
    Injury
    Date Received
    July 7, 2014
    Date of Event
    June 4, 2014
    Report Date
    June 6, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINED ON LVAD SUPPORT WITH THE PUMP. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED CEREBROVASCULAR ACCIDENT (CVA) AND THE SUSPECTED THROMBUS COULD NOT BE CONCLUSIVELY DETERMINED. THE PATIENT WAS TREATED WITH IV HEPARIN THERAPY AND THE PATIENT'S PARAMETERS NORMALIZED. ALTHOUGH THE PATIENT STILL HAD PARAPLEGIA, HE WAS SENT HOME. THE PATIENT REMAINS ON VAD SUPPORT WITH THE PUMP AND NO FURTHER ISSUES HAVE BEEN REPORTED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROX 10 WEEKS POST IMPLANT, IT WAS REPORTED THAT THE PT WAS ADMITTED INTO THE EMERGENCY ROOM WITH RIGHT PARAPLEGIA, AS A RESULT OF A CEREBROVASCULAR ACCIDENT (CVA). IN THE DAYS PRIOR, THE PT WAS SEEN FOR ROUTINE VISITS. THE PT'S LDH HAD ELEVATED AND THE PT'S COUMADIN DOSAGE WAS INCREASED. THE SYSTEM CONTROLLER EVENT HISTORY INDICATED LOW FLOW ALARMS ON MULTIPLE DAYS. A BLOOD AGGREGOMETRY ECHOCARDIOGRAM WAS PERFORMED AND INDICATED NO OBSTRUCTION. THE PT WAS PUT ON IV HEPARIN AND PUMP THROMBOSIS WAS SUSPECTED. A RAMP STUDY HAS BEEN SCHEDULED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT A RAMP STUDY WAS PERFORMED AND PUMP THROMBOSIS WAS SUSPECTED; THEREFORE IV HEPARIN THERAPY WAS CONTINUED. ON (B)(6) 2014 THE PUMP PARAMETERS HAD STABILIZED AND THE PATIENT'S LDH HAD STARTED TO DECREASE. THE PATIENT CONTINUES TO HAVE PARAPLEGIA; HOWEVER IS STABLE AT HOME IN GOOD GENERAL CONDITION WITH NO FURTHER EVENTS REPORTED. IT WAS ALSO REPORTED THAT THE HOSPITAL TEAM STATES THAT THE PARAPLEGIA OCCURRED AS RESULT OF THE HEMORRHAGIC CVA (CEREBRAL THROMBOEMBOLISM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    394902 HEARTMATE II LVAS, EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106016 134554

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other