BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3874008 · Received June 5, 2014

    Report

    Report Number
    2916596-2014-00927
    Event Type
    Injury
    Date Received
    June 5, 2014
    Date of Event
    April 16, 2014
    Report Date
    May 7, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE LVAD INCLUDING THE ASSOCIATED SYSTEM CONTROLLER WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE PUMP ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT HAS HAD ELEVATED LACTATE DEHYDROGENASE (LDH) LEVELS ASSOCIATED WITH HEMATURIA. A RECENT ECHOCARDIOGRAM THAT WAS PERFORMED REVEALED THAT THE AORTIC VALVE WAS OPENING EVERY BEAT AND THE EJECTION FRACTION REMAINED AT 30%. IT WAS REPORTED THAT PRIOR PUMP EXCHANGE ON (B)(6) 2014 RESULTED IN LEAVING IN BOTH INFLOW AND OUTFLOW CONDUITS, THUS, THE PUMP WAS ONLY EXPLANTED. THE PATIENT HAD CARE OF RECENT GIB RESULTING IN CESSATION OF ANTICOAGULATION; HOWEVER, SHE WAS RESTARTED ON HEPARIN GTT. SHORTLY AFTER HEPARIN WAS STOPPED, IT WAS NOTED THAT THE PATIENT'S LDH ROSE ACUTELY. THERE WERE SOME EPISODES OF BRIEF HYPERTENSION AND THE RV FUNCTION WAS NOTED TO BE GOOD. POST LVAD EXCHANGE THE PATIENT CONTINUED TO HAVE ELEVATED LDH IN THE 500 RANGE WITH INTERMITTENT POWER SPIKES BUT WAS OTHERWISE STABLE. THE PATIENT WAS BRIDGED WITH HEPARIN TO THERAPEUTIC INTERNATIONAL NORMALIZED RATIO (NR) OF 2-3 WITH WARFARIN. THE PATIENT RECOVERED FROM THE SURGERY AND WAS AWAITING THERAPEUTIC INR FOR DC WHEN SHE STARTED GIB REQUIRING AN ESOPHAGOGASTRODUODENOSCOPY (EGD). DURING THIS PROCEDURE THE HEPARIN WAS STOPPED (FOR A "LIMITED TIME") AND RESUMED POST PROCEDURE. ON THE DAY FOLLOWING THE PROCEDURE, THE PATIENT'S LDH ROSE TO 900 AND PEAKED AT 1500 WITH A PLASMA FREE HEMOGLOBIN OF 15 AND 3+ BLOOD IN HER URINE AND UROBILINOGEN. THE PATIENT IS CURRENTLY ON BIVALIRUDIN WITH AN LDH HOLDING AT 1000-1100. THE PATIENT HAS INTERMITTENTLY HAD SYMPTOMS OF CHEST PAIN AND SHORTNESS OF BREATH (HER CARDIOMYOPATHY ETIOLOGY IS NON-ISCHEMIC.) SHE HAS HAD MULTIPLE ECHOCARDIOGRAMS WHERE THE AORTIC VALVE WOULD OPEN WITH EVERY BEAT EVEN WITH INCREASING THE PUMP SPEED AS HIGH AS 10800 RPM, THE AV REMAINS PARTIALLY CLOSED AND NORMAL RV FUNCTION. IT WAS REPORTED THAT THE PATIENT WAS HAVING FREQUENT "LOW FLOW" VISUAL ALARMS (NO AUDIBLE ALARMS ASSOCIATED WITH THIS), LOWER POWERS, HIGH PULSATILITY INDEX (PI) VALUES. IT WAS REPORTED THAT THE PATIENT NOW HAS IMPROVED HIGH FLOWS WITH HIGHER POWERS AND PLS. A REVIEW OF THE SUBMITTED LOG FILE HISTORY CONFIRMED THE REPORT OF LOW FLOW HAZARDS. THE PUMP SPEED WAS MAINTAINED AND THE POWER LEVELS WERE RELATIVELY NORMAL WITH A TRANSIENT SPIKE. THE LVAD INCLUDING THE ASSOCIATED SYSTEM CONTROLLER WAS RETURNED AND RECEIVED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328433 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 138605

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention