BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3032445 · Received March 29, 2013

    Report

    Report Number
    2916596-2013-00351
    Event Type
    Injury
    Date Received
    March 29, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 27, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT PT WAS ADMITTED FOR RIGHT VENTRICLE FAILURE (RVF) AND POSSIBLE PULMONARY EMBOLISM (PE). THE PT HAS ELEVATED LIVER ENZYMES, HEPATIC CONGESTION, ACUTE RENAL FAILURE. THE PT WAS ON INOTROPES AND BEING TREATED FOR A POSSIBLE PULMONARY EMBOLISM. AT THIS TIME THERE WERE NO KNOWN PROBLEMS WITH THE PUMP AND APPEARED TO BE WORKING WELL. ADDITIONAL INFORMATION SUBMITTED TO THE MFR INDICATED THAT SOME OF THE SYMPTOMS THE PT WAS EXPERIENCING WHEN ADMITTED WERE DUE TO WORSENING HEART FAILURE WITH COMPLAINTS OF MORBIDITIES; VENTRICULAR TACHYCARDIA (VT), WORSENING RENAL FUNCTION, HEMOGLOBINURIA, HEPATIC CONGESTION WITH ELEVATED LIVER FUNCTION TESTS ("LFT 1/2S"). THE SYMPTOMS THE PT WAS FOR PUMP THROMBUS. ANTICOAGULATION REGIMEN CONSISTED OF ASPIRIN (ASA), COUMADIN, TRENTAL, HEPARIN DRIP AND MILRINONE. OVER THE WEEKEND THE PT HAS SURGES IN PUMP POWER AND FLOW UP TO 18. THE HOSPITAL DECIDED TO EXCHANGE THE PUMP. DURING THE PUMP EXCHANGE, THE DOCTOR NOTED THAT THE PUMP HAD MIGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130706 HEARTMATE II LVAS DSQ: LEFT VENTICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 114081

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention