BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3820574 · Received April 11, 2014

    Report

    Report Number
    2916596-2014-00541
    Event Type
    Injury
    Date Received
    April 11, 2014
    Date of Event
    March 15, 2014
    Report Date
    March 15, 2014
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT REMAINS ONGOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE PT IS CLINICALLY STABLE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: A ROOT CAUSE FOR THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION AS THE PUMP WAS NOT RETURNED FOR EVALUATION. A SYSTEM CONTROLLER DATA LOG FILE WAS RECEIVED. REVIEW OF THE SYSTEM CONTROLLER DATA LOG FILE REVEALED INTERMITTENT LOW FLOW AND LOW SPEED HAZARD ALARMS AS WELL AS ONE MOTOR STOP EVENT THAT WAS NOT ASSOCIATED WITH A PUMP DISCONNECT EVENT. THE EVENTS ALL OCCURRED WHILE THE PATIENT WAS OPERATING WHILE CONNECTED TO THE POWER MODULE POWER SOURCE. THE PATIENT REMAINED ONGOING ON LVAD SUPPORT WITH NO ADDITIONAL COMPLAINTS UNTIL ULTIMATELY BEING TRANSPLANTED ON (B)(6) 2014. BASED ON THE MANUFACTURER'S COMPLAINT HISTORY AND SIMILAR REPORTED EVENTS, LOW SPEED/FLOW HAZARDS, ELEVATED POWER AND PULSATILITY INDEX (PI), AND PUMP STOP EVENTS WHILE CONNECTED TO THE POWER MODULE ARE CONSISTENT WITH A COMPROMISED WIRE IN THE PERCUTANEOUS LEAD. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS HOME AND EXPERIENCED RED HEART ALARMS AND PUMP STOPPAGE WHILE SLEEPING. THE PT COULD NOT REMEMBER IF HE HAD BEEN TURNING IN BED OR NOT. THE PT CAME INTO THE HOSPITAL AND ANOTHER ALARM WAS OBSERVED WHEN THE PT SAT DOWN. EXTERNAL MANIPULATION OF THE PERCUTANEOUS LEAD DID NOT RESULT IN ANY ALARMS. X-RAYS WERE SENT TO THE MANUFACTURER FOR REVIEW AND WERE FOUND TO BE UNREMARKABLE. IN ADDITION, LOG FILES WERE SENT TO THE MANUFACTURER AND UPON REVIEW, CONFIRMED LOW FLOW HAZARDS AND PUMP STOPPAGES ON THE POWER MODULE. THE PT WILL BE LISTED FOR TRANSPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT REPORTEDLY HAD A DRIVELINE FRACTURE (SHORT TO SHIELD). THE PATIENT WAS MAINTAINED ON BATTERIES, AND THE LVAD FUNCTIONED AS INTENDED WITH ALL THE PUMP PARAMETERS BEING WITHIN THE NORMAL LIMITS. A MODIFIED UNGROUNDED CABLE WAS PROVIDED TO THE PATIENT. THE PATIENT WAS SUCCESSFULLY TRANSPLANTED ON (B)(6) 2014 AND RECOVERED FULLY FROM THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221565 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP 104911 115867

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention