BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6035853 · Received October 17, 2016

    Report

    Report Number
    2916596-2016-02012
    Event Type
    Malfunction
    Date Received
    October 17, 2016
    Date of Event
    September 21, 2016
    Report Date
    September 21, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 10 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: CORRECTED INFORMATION. IT WAS INITIALLY REPORTED THAT THE DEVICE WAS NOT RETURNING FOR EVALUATION. THE DEVICE WAS SUBSEQUENTLY RECEIVED. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    THE REPORTED LOW FLOW ALARMS WERE CONFIRMED BASED ON THE EVALUATION OF THE SUBMITTED LOG FILE; HOWEVER, THE REPORTED INFLOW MALPOSITION WAS NOT CONFIRMED. EVALUATION OF THE EXPLANTED PUMP CONFIRMED THROMBUS INSIDE THE PUMP. THE PUMP WAS RETURNED ASSEMBLED WITH THE DRIVELINE SEVERED APPROXIMATELY 7 INCHES FROM THE PUMP HOUSING. THE SEVERED PORTION OF THE DRIVELINE WAS NOT RETURNED. THE OUTLET STATOR REVEALED DARK RED, SOFT DEPOSITION. THE DEPOSITION'S LACK OF LAMINATED LAYERING INDICATED THAT IT DID NOT INITIALLY FORM IN THE OUTLET STATOR. ITS AREAS OF DENATURATION ADJACENT TO THE BEARING BALL AND THE PRESENCE OF CONTACT MARKS ON THE ROTOR SUGGEST THAT IT WAS LIKELY PRESENT WHILE THE DEVICE WAS SUPPORTING THE PATIENT. ALTHOUGH A SPECIFIC CAUSE FOR THE DEPOSITION AND A TIMEFRAME FOR WHICH IT WAS PRESENT IN THE PUMP COULD NOT BE DETERMINED, IT COULD HAVE POTENTIALLY CONTRIBUTED TO THE REPORT OF LOW FLOW. ELECTRICAL CONTINUITY TESTING OF THE RETURNED PORTION OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. THE PUMP WAS CLEANED, REASSEMBLED, AND FUNCTIONALLY TESTED UNDER NORMAL OPERATING CONDITIONS USING A MOCK CIRCULATORY LOOP. THE DATA RETRIEVED FROM THAT TESTING REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES, COMPARABLE TO WHAT WAS RECORDED DURING THE MANUFACTURING PROCESS. THE PUMP OPERATED AS INTENDED. THROMBUS IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT'S LVAD SYSTEM PRODUCED NUMEROUS LOW FLOW ALARMS ON (B)(6) 2016. LOG FILE ANALYSIS BY THE MANUFACTURER'S TECHNICAL SERVICES REPRESENTATIVE CONFIRMED THE LOW FLOW ALARMS. IT WAS REPORTED THAT A MAL-POSITIONED LVAD INFLOW CONDUIT WAS A SIGNIFICANT CONTRIBUTOR TO THE LOW FLOW ALARMS. THE PATIENT WAS MONITORED CLOSELY AS AN INPATIENT AND DID NOT SHOW ANY SIGNS OR SYMPTOMS OF HEMOLYSIS. LACTATE DEHYDROGENASE (LDH) VALUES WERE CHECKED REGULARLY. ON (B)(6) 2016, THE PATIENT'S LVAD SYSTEM BEGAN TO HAVE MORE CONSISTENT LOW FLOW ALARMS. THE PATIENT'S POCKET SYSTEM CONTROLLER WAS EXCHANGED TO AN EXTERNAL PERIPHERAL CONTROLLER TO HOPEFULLY KEEP CALCULATED FLOW READING ABOVE ALARM THRESHOLD OF 2.5 LPM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT RECEIVED A HEART TRANSPLANT ON (B)(6) 2016. REPORTEDLY, THE PATIENT WAS MOVED UP ON THE TRANSPLANT LIST DUE TO "VAD MALFUNCTION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    684464 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R