BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3962668 · Received July 16, 2014

    Report

    Report Number
    2916596-2014-01196
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 16, 2014
    Report Date
    June 16, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE EVALUATION OF THE RETURNED HEARTMATE II LVAD, SERIAL NUMBER (B)(4), WAS UNABLE TO DETERMINE A CORRELATION BETWEEN THE PUMP AND THE REPORTED INFECTION. THE PUMP WAS RETURNED ASSEMBLED WITH THE DRIVELINE CUT APPROXIMATELY 9 INCHES FROM THE PUMP HOUSING AND THE REST OF THE DRIVELINE WAS ALSO RETURNED. ALL PARTS OF THE SEALED INFLOW CONDUIT, APPROXIMATELY 4 INCHES OF THE SEALED OUTFLOW GRAFT, AND THE OUTFLOW GRAFT BEND RELIEF WERE RETURNED, AND THE INLET AND OUTFLOW ELBOWS WERE RETURNED ATTACHED TO THE PUMP. A BEND RELIEF COLLAR WAS PRESENT AND WAS SECURED WITH A BLUE SUTURE. PRIOR TO DISASSEMBLY, VISUAL INSPECTION OF THE PROXIMAL SIDE OF THE INLET STATOR REVEALED A RED AND WHITE TISSUE-LIKE DEPOSITION WITHIN THE PUMP. UPON DISASSEMBLY, THE EVALUATION REVEALED DEPOSITIONS AROUND THE ROTOR BEARING BALL AND OUTLET STATOR. THE THROMBUS SURROUNDING THE ROTOR BEARING BALL APPEARED TO HAVE FORMED IN LAMINATED LAYERS, WHICH IS AN INDICATION THAT IT LIKELY DEVELOPED WHILE THE PUMP WAS SUPPORTING THE PATIENT; HOWEVER, A SPECIFIC TIME PERIOD IN WHICH IT DEVELOPED AND THE DURATION OF ITS PRESENCE IN THE PUMP COULD NOT BE CONCLUSIVELY DETERMINED. THE SOFT, WHITE DEPOSITION IN THE OUTLET STATOR WAS LOOSELY SEATED. THERE WAS NO EVIDENCE OF LAMINATION OR DENATURING, AND THERE WERE NO CONTACT MARKS ON THE ROTOR TO INDICATE THAT IT WAS PRESENT IN THE PUMP WHILE IT WAS OPERATING. THE PRESENCE OF THESE DEPOSITIONS IN THE PUMP DURING OPERATION WOULD HAVE CONTRIBUTED TO THE REPORTED ELEVATED LDH/HEMOLYSIS. THE DISASSEMBLED PUMP¿S BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES WERE EXAMINED UNDER A MICROSCOPE, AND NO ABNORMALITIES WERE OBSERVED. THE DRIVELINE WAS TESTED FOR CONTINUITY AND ALL WIRES WERE FOUND TO BE ELECTRICALLY INTACT. THE PUMP WAS CLEANED, REASSEMBLED, AND FUNCTIONALLY TESTED UNDER LOADED CONDITIONS USING A MOCK CIRCULATORY LOOP. THE RETRIEVED DATA FROM THIS TESTING REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES COMPARABLE TO WHAT WAS RECORDED DURING THE MANUFACTURING PROCESS, AND THE PUMP OPERATED AS INTENDED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PT HAD AN ELEVATION IN LACTATE DEHYDROGENASE AND UNDERWENT A RAMP STUDY. A REVIEW OF THE LOG FILE SUBMITTED TO THE MANUFACTURER FOR ANALYSIS DID NOT REVEAL ANY ATYPICAL EVENTS RECORDED. THE RESULT OF THE RAMP STUDY WAS A NEGATIVE RAMP TEST. THE PATIENT'S LACTATE DEHYDROGENASE LEVEL PEAKED AT 1185 AND WAS DISCHARGED WITH A LACTATE DEHYDROGENASE LEVEL OF 446. IT WAS ALSO REPORTED THAT THE PATIENT HAS A DRIVELINE INFECTION. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE PATIENT'S WOUND WAS CULTURED AND IT DEVELOPED INTO SERRATIA MARCESCENS, WHICH THE PATIENT WAS TREATED FOR WITH CEFTAZIDIME. MINIMAL DRAINAGE PERSISTED, BUT THE PATIENT WAS FEELING ALRIGHT AND THE PATIENT'S DRESSING WAS DRY. THE PATIENT WAS PRESCRIBED CIPROFLOXACIN FOR TWO WEEKS AND WAS TO BE ASSESSED AFTERWARDS. THE PATIENT WAS ASYMPTOMATIC AND RECEIVED A ROUTINE TRANSPLANT ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    415371 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 130576

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention