BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3874996 · Received June 2, 2014

    Report

    Report Number
    2916596-2014-00881
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    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 (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT INITIALLY PRESENTED TO THE CLINIC ON (B)(6) 2014 IN A WHEELCHAIR WITH A 6 LB WEIGHT GAIN, FATIGUE, GENERALIZED PAIN, AND AN LDH OF 600 (USUALLY 200). AN ECHO RAMP STUDY WAS UNREMARKABLE. THE PT WAS STARTED ON DIURETICS AND REPORTED TO BE "FEELING BETTER." A PRE-SCHEDULED 6 MONTH F/U CT FOR PULMONARY NODULES WAS LATER PERFORMED WHICH FOUND A DISCONNECTED PUMP SEALED OUTFLOW GRAFT BEND RELIEF. THE PT WAS ADMITTED TO THE HOSPITAL FOR REATTACHMENT OF THE BEND RELIEF. HEPARIN WAS STARTED BRIEFLY FOR AN INR OF 1.5 THEN STOPPED IN ANTICIPATION OF SURGERY. THREE ISOLATED INCIDENTS OF BRIEF PUMP POWER ELEVATIONS WERE NOTED ON THE HISTORY; THERE WERE NO OTHER ABNORMAL PARAMETERS. DURING SURGERY ON (B)(6) 2014, A LARGE AMOUNT OF ADHESIONS WERE ENCOUNTERED. THE LVAD WAS STOPPED FOR 36 MINS DURING THE BEND RELIEF ATTACHMENT. TWO SMALL HOLES THAT WERE FOUND IN THE OUTFLOW GRAFT WERE REPAIRED BY THE SURGEON. VAD PARAMETERS WERE WITHIN NORMAL LIMITS AT THE END OF THE CASE. CT SCAN SHOWED GOOD POSITION OF THE OUTFLOW GRAFT WITH THE COLLAR INTACT. THE PT LDH WAS RISING. ECHO RAMP STUDY SHOWS LEFT VENTRICLE IS UNLOADING. THE PT WAS BEING TREATED MEDICALLY (REPORTED ON MEDWATCH #0002916596-2014-00880). THE PT WAS TRANSFERRED TO ANOTHER CENTER ON (B)(6) 2014. ARRIVED AT THE CENTER WITH OLIGURIA, RHF, AND LDH OF 5000. THE VAD COORDINATOR DESCRIBED A PUMP STOP DURING A RAMP STUDY. NO ALARMS DURING THE STUDY, THIS WAS FOUND UPON CONTROLLER HISTORY REVIEW. MECHANISM FOR PUMP STOP WAS UNCLEAR. THE PT'S LDH RISING TO 900'S, URINE CLEAR, LEFT VENTRICULAR UNLOADING WITH RAMP STUDY. CT SCAN SHOWED GOOD POSITION OF OUTFLOW GRAFT WITH THE COLLAR INTACT. CHEST X-RAY SHOWS DRIVELINE PATENCY. THE PT WAS UNDER MEDICAL MANAGEMENT. THE PT REC'D AN EMERGENT PUMP EXCHANGE (B)(6) 2014. PUMP ONLY WAS EXCHANGED USING A SUB-COASTAL APPROACH BY THE SURGEON. THERE HAS NOT BEEN ANY FURTHER BLEEDING THUS FAR. LDH DECREASING AND IS NOW MAKING URINE. HEMATOLOGY FOLLOWING FOR HIT. THE PT IS RECOVERING. HEMOLYSIS IS SIGNIFICANTLY DECREASED. NO SIGNS OF CONGESTIVE HEART FAILURE. THERE IS POSITIVE E COLI IN SPUTUM. RESTRAINTS FOR ETOH WITHDRAWAL AND DELIRIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322496 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention NA.