BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4132834 · Received September 29, 2014

    Report

    Report Number
    2916596-2014-01731
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    September 2, 2014
    Report Date
    September 2, 2014
    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 ATTACHED USER FACILITY MEDWATCH REPORT WAS RECEIVED FROM THE INTERMACS REGISTRY. THE USER FACILITY NUMBER WAS NOT PROVIDED. THE INTERMACS IDENTIFIER IS (B)(4).

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. THE REPORT OF SUSPECTED THROMBUS WAS CONFIRMED BASED ON THE EVALUATION OF THE RETURNED. THE PUMP WAS RETURNED ASSEMBLED WITH THE DRIVELINE CUT APPROXIMATELY 2" FROM THE PUMP HOUSING AND THE SEVERED PORTION OF THE DRIVELINE WAS NOT RETURNED. THE SEALED INFLOW CONDUIT, THE SEALED OUTFLOW GRAFT, AND THE OUTFLOW GRAFT BEND RELIEF WERE NOT RETURNED. THE OUTFLOW ELBOW WAS RETURNED, ATTACHED TO THE PUMP OUTLET PORT. PRIOR TO DISASSEMBLY, THE PROXIMAL-SIDE OF THE INLET STATOR REVEALED EVIDENCE OF DEPOSITION IN THE PUMP. THE DISTAL-SIDE OF THE OUTLET STATOR REVEALED NO EVIDENCE OF DEPOSITION IN THE PUMP. EXAMINATION OF THE DISTAL-SIDE OF THE INLET STATOR UPON DISASSEMBLY REVEALED A LARGE, DENATURED THROMBUS RING ADHERED TO THE INLET BEARING CUP. THE RING APPEARED TO HAVE FORMED IN LAMINATED LAYERS WHICH IS INDICATION THAT IT DEVELOPED OVER AN UNDETERMINED AMOUNT OF TIME WHILE THE PUMP WAS OPERATING. THERE WAS EVIDENCE OF THE THROMBUS FOUND ON THE INLET BEARING BALL AND INLET SECTION OF THE ROTOR, WHICH SUGGESTS THAT THE DEPOSITION WAS LIKELY, ADHERED TO BOTH THE BEARING CUP AND BALL PRIOR TO DISASSEMBLY OF THE PUMP. EVALUATION OF THE BODY OF THE ROTOR REVEALED A NON-LAMINATED DEPOSITION SITUATED ON THE BODY AND BLADES OF THE ROTOR. THE STRUCTURE OF THE DEPOSITION SUGGESTS THAT IT DID NOT DEVELOP ON THE ROTOR; HOWEVER, PORTIONS OF THE DEPOSITION WERE SIMILAR TO THE RING FOUND IN THE DISTAL-SIDE OF THE INLET STATOR, AND THE DEPOSITION MAY HAVE POTENTIALLY ORIGINATED THERE. ALTHOUGH ITS SPECIFIC ORIGIN COULD NOT BE CONCLUSIVELY DETERMINED, AREAS OF THE DEPOSITION HAD EVIDENCE OF DENATURING WHICH INDICATES THAT IT WAS LIKELY PRESENT IN THE PUMP WHILE IT WAS IN OPERATION. THE THROMBUS FOUND IN THE PUMP WOULD HAVE CREATED ADDITIONAL RESISTANCE ON THE SPINNING ROTOR, POTENTIALLY CONTRIBUTING TO THE REPORTED CESSATION OF THE MOTOR. UPON REMOVAL OF THE OBSERVED DEPOSITIONS, THE DEVICE WAS CLEANED. THE DISASSEMBLED PUMP'S BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES WERE EXAMINED UNDER A MICROSCOPE AND NO ANOMALIES WERE OBSERVED. ELECTRICAL CONTINUITY TESTING OF THE RETURNED PORTION OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. THE PUMP WAS 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 AND THE DEVICE FUNCTIONED AS INTENDED. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION 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

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE INTERMACS REGISTRY STATING: PUMP THROMBOSIS, EXCHANGED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT EXPERIENCED PUMP STOPPAGE ALARM, AND WAS EMERGENTLY ADMITTED TO THE HOSPITAL. THE PATIENT FAILED A RAMP STUDY TEST AT 13000 RPM WITHOUT DECOMPRESSION OF LEFT VENTRICLE. THE PATIENT UNDERWENT A PUMP EXCHANGE FROM ONE LVAD TO ANOTHER LVAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    606083 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 142307

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention