BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3983372 · Received July 7, 2014

    Report

    Report Number
    2916596-2014-01128
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR WAS UNABLE TO CONDUCT AN INVESTIGATION OF THE DEVICE AS THE PT REMAINS ONGOING WITH THE IMPLANTED DEVICE. HOWEVER, THE REPORT OF SPEED REDUCTIONS AND PUMP STOPS WAS CONFIRMED BASED ON THE EVAL OF THE REPLACED PORTION OF THE PERCUTANEOUS LEAD (LEAD) THAT WAS RETURNED FOR EVAL. APPROX 12" OF THE EXTERNAL PORTION/DISTAL END OF THE PERCUTANEOUS LEAD WAS RETURNED FOR EVAL. EXAMINATION OF THE RETURNED PORTION OF LEAD CONFIRMED THAT THE YELLOW WIRE WAS PARTIALLY FRACTURED AT THE TERMINUS OF THE BEND RELIEF. AS A RESULT, THE UNDERLYING CONDUCTORS WERE EXPOSED, BUT THE WIRE REMAINED ELECTRICALLY INTACT. THE CHARACTERISTIC OF THIS DISRUPTION APPEARED CONSISTENT WITH FATIGUE AS A RESULT OF REPETITIVE FLEXING OF THE LEAD IN THIS LOCATION. THE EXAMINATION OF THE AFFECTED AND NON-AFFECTED WIRES DID NOT REVEAL ANY EVIDENCE OF MECHANICAL DAMAGE DUE TO CRUSHING OR PINCHING. THE REPORTED SPEED REDUCTIONS AND PUMP STOPS WOULD HAVE OCCURRED AS A RESULT OF THE EXPOSED CONDUCTORS OF THE WIRE CONTACTING THE SHIELD AND SHORTING TO GROUND WHILE CONNECTED TO THE POWER MODULE. NO FURTHER INFO IS AVAILABLE. THE MFR IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT WAS IN THE HOSP WHEN THEY RECEIVED SPEED DROPS AND LOW FLOW ALARMS. MANUAL MANIPULATION OF THE DRIVELINE CONFIRMED THESE EVENTS. THE VAD COORDINATOR REPORTED AN ANOMALY UNDER THE SILICONE JACKET ABOUT 1-2 INCHES FROM THE DISTAL CONNECTOR OF THE DRIVELINE. THERE WAS REPRODUCIBLE PUMP STOPPAGE AND SPEED DRIP WHEN THIS AREA WAS MANIPULATED. THE LOG FILE AND X-RAY WERE BOTH CONSISTENT WITH A PERCUTANEOUS LEAD ISSUE. A PERCUTANEOUS LEAD REPLACEMENT WAS COMPLETED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395171 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 109871

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention