BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2861325 · Received December 5, 2012

    Report

    Report Number
    2916596-2012-01178
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 6, 2012
    Report Date
    November 6, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS RETURNED TO THE MFR FOR EVAL. THE PERCUTANEOUS LEAD WAS SEVERED APPROX 7" FROM THE PUMP HOUSING, AND THE SEVERED PORTION OF THE PERCUTANEOUS LEAD WAS NOT RETURNED AND EXAMINATION SHOWED NO EVIDENCE OF ADHERED DEPOSITION OF THROMBUS FORMATIONS ON THE INTERIOR OF THE GRAFTS. EXAMINATION OF THE PUMP ROTOR INTEL SECTION REVEALED A LAMINATED, DENATURED THROMBUS FORMATION SURROUNDING THE ROTOR INLET BEARING CUP AND BEARING BALL. THE DEPOSITION APPEARED TO FORM AROUND THE INLET BEARINGS IN LAMINATED LAYERS, WHICH IS AN INDICATION THAT IT DEVELOPED OVER AN UNDETERMINED AMOUNT OF TIME WHILE THE PUMP WAS IN OPERATION. ALTHOUGH A CAUSE FOR THE THROMBUS DEVELOPMENT COULD NOT BE DETERMINED, IT WOULD HAVE LIKELY CAUSED RESISTANCE ON THE SPINNING ROTOR AND OBSTRUCTED BLOOD FLOW THROUGH THE PUMP. EXAMINATION OF THE BODY OF THE ROTOR AND THE OUTLET STATOR SHOWED NO EVIDENCE OF DEPOSITIONS OR THROMBUS FORMATIONS. THE PUMP BEARINGS, ROTOR AND BLOOD CONTACTING SURFACES WERE EXAMINED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED THAT WOULD HAVE CONTRIBUTED TO THE THROMBUS FORMATION. THE PUMP WAS CLEANED, REASSEMBLED, AND FUNCTIONALLY TESTED UNDER NORMAL OPERATING CONDITIONS ACCORDING TO OUR MFG PROCEDURE USING A MOCK CIRCULATORY LOOP, AND FUNCTIONED AS INTENDED. THE DATA RETRIEVED FROM OUR TESTING REVEALED NORMAL PUMP POWER CONSUMPTION COMPARABLE TO THE PUMP POWER CONSUMPTION RECORDED DURING THE MFG PROCESS. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET ALL APPLICABLE SPECIFICATIONS UPON PRODUCT RELEASE. NO FURTHER INFO IS AVAILABLE. THE MFR 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'S LDH ELEVATED TO 3000, HIS HEMOGLOBIN HAD DROPPED TO 5, AND HE WAS UNABLE TO TOLERATE ANTICOAGULATION MEDICATION. THE PT ALSO EXPERIENCED GI BLEEDING AND A REACTION DURING A BLOOD TRANSFUSION. A (B)(4) STUDY WAS PERFORMED AND THERE WERE NO CHANGES IN THE VENTRICLE SIZE WITH CHANGES IN THE PUMP SPEED. THE PT WAS TAKEN BACK TO THE OPERATING ROOM AND HIS PUMP WAS EXCHANGED. THE PT REMAINS ONGOING WITH THE NEW LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 116756

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention