BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6106003 · Received November 16, 2016

    Report

    Report Number
    2916596-2016-02233
    Event Type
    Death
    Date Received
    November 16, 2016
    Date of Event
    October 21, 2016
    Report Date
    October 30, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE  14 DAYS. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETE. THE EVENT OCCURRED AT (B)(6). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURERS INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: A CORRELATION BETWEEN THE DEVICE AND THE REPORTED HEMORRHAGIC STROKE COULD NOT BE CONCLUSIVELY DETERMINED. STROKE IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. THE PUMP WAS RETURNED ASSEMBLED WITH THE DRIVELINE CUT APPROXIMATELY 3.5 INCHES FROM THE PUMP HOUSING AND THE DISTAL PORTION OF THE DRIVELINE WAS ALSO RETURNED. THE SEALED INFLOW CONDUIT (INLET TUBE, FLEX SECTION, AND INLET ELBOW) WAS RETURNED ATTACHED TO THE PUMP¿S INLET PORT. THE SEALED OUTFLOW CONDUIT (GRAFT, BEND RELIEF, AND OUTFLOW ELBOW) WAS RETURNED ATTACHED TO THE PUMP¿S OUTLET PORT. THE SEALED OUTFLOW GRAFT BEND RELIEF COLLAR WAS SUTURED IN PLACE AROUND THE OUTFLOW GRAFT NUT. EVALUATION OF THE SEALED INFLOW AND OUTFLOW CONDUITS REVEALED NO EVIDENCE OF DEPOSITIONS OR THROMBUS FORMATIONS. VISUAL EXAMINATION OF THE PUMP¿S BLOOD-CONTACTING SURFACES UPON DISASSEMBLY OF (B)(4) REVEALED A SMALL DEPOSITION ADJACENT TO THE BEARING BALL WITHIN THE PROXIMAL SIDE OF THE OUTLET STATOR. ITS NON-LAMINATED STRUCTURE AND LACK OF DENATURATION INDICATE THAT THIS DEPOSITION DID NOT LIKELY FORM IN THE OUTLET STATOR. ADDITIONALLY, THIS DEPOSITION WAS NOT ADHERED TO THE DEVICE AND THERE WERE NO CONTACT MARKS AT THE DISTAL END OF THE ROTOR TO SUGGEST THAT IT WAS PRESENT IN THE OUTLET STATOR WHILE (B)(4) WAS SUPPORTING THE PATIENT. THE ORIGIN OF THIS DEPOSITION AND THE DURATION WHICH IT WAS WITHIN THE PUMP COULD NOT BE DETERMINED. FURTHERMORE, AN ASSOCIATION BETWEEN THIS DEPOSITION AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE ESTABLISHED. 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 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 AND THE DEVICE FUNCTIONED AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED 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. IT WAS REPORTED THAT THE PATIENT HAD A HEMORRHAGIC STROKE AND WAS COMATOSE ON (B)(6) 2016. THE PATIENT EXPIRED ON (B)(6) 2016. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    756907 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death