BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 4889540 · Received July 2, 2015

    Report

    Report Number
    2916596-2015-01213
    Event Type
    Death
    Date Received
    July 2, 2015
    Date of Event
    May 27, 2015
    Report Date
    June 4, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE REPORT OF SUSPECTED PUMP THROMBOSIS AND HEMOLYSIS WAS CONFIRMED BASED ON THE EVALUATION OF THE RETURNED PUMP. HOWEVER, A CORRELATION BETWEEN THE DEVICE AND THE REPORTED SEPTIC SHOCK, HEMORRHAGIC STROKE, AND SUBSEQUENT MULTISYSTEM ORGAN FAILURE AND DEATH COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. INFECTION, SEPSIS, BLEEDING, AND STROKE ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. UPON DISASSEMBLY OF (B)(4), EXAMINATION OF THE OUTLET STATOR REVEALED A LARGE THROMBUS FORMATION SURROUNDING THE OUTLET BEARING BALL AND LODGED BETWEEN ALL THREE STATOR BLADES. THE THROMBUS LACKED LAMINATED LAYERING, WHICH SUGGESTS THAT IT DID NOT DEVELOP IN THIS LOCATION. ALTHOUGH ITS ORIGINS AND A DURATION OF TIME FOR WHICH IT WAS PRESENT IN THE PUMP COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, THE AREAS OF DENATURATION ON THE THROMBUS AS WELL AS THE CONTACT MARKS OBSERVED ON THE OUTLET PORTION OF THE ROTOR AND THE OUTLET BEARING CUP INDICATE THAT IT WAS PRESENT WHILE THE PUMP WAS OPERATING. ALTHOUGH A SPECIFIC CAUSE FOR THE OBSERVED THROMBUS FORMATION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, IT WAS OCCLUDING THE MAJORITY OF THE BLOOD FLOW PATH THROUGH THE OUTLET STATOR AND COULD HAVE CONTRIBUTED TO THE REPORTED HEMOLYSIS. IN ADDITION, EXAMINATION OF THE INFLOW CONDUIT REVEALED A SOFT, LOOSE BEIGE DEPOSITION MIXED WITH CLOTTED BLOOD EXTENDING THROUGH THE INFLOW GRAFT AND INLET ELBOW. A SIMILAR LOOSE DEPOSITION MIXED WITH CLOTTED BLOOD WAS ALSO OBSERVED EXTENDING THROUGH THE GRAFT ATTACHMENT AND THE PROXIMAL HALF OF THE RETURNED PORTION OF OUTFLOW GRAFT MATERIAL. ADDITIONALLY, ANOTHER LOOSE WHITE DEPOSITION WAS FOUND IN THE OUTLET ELBOW AND DRAPED ALONG THE BODY OF THE ROTOR. THE DEPOSITIONS APPEARED TO BE THE RESULT OF POOR SURFACE WASHING DUE TO AN INTERRUPTION IN FLOW THROUGH THE PUMP; HOWEVER, A SPECIFIC CAUSE FOR THE DEVELOPMENT OF THE DEPOSITIONS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ALTHOUGH A TIME FRAME FOR WHICH THE DEPOSITIONS WERE PRESENT IN THE PUMP COULD NOT BE CONCLUSIVELY DETERMINED, THEIR SOFT TEXTURE AND LACK OF ADHERENCE TO THE BLOOD CONTACTING SURFACES INDICATES THAT THE DEPOSITIONS WERE NOT PRESENT FOR AN EXTENDED PERIOD OF TIME. MOREOVER, THE DEPOSITIONS APPEARED TO HAVE BEEN A SINGLE, CONTINUOUS FORMATION THROUGH THE PUMP PRIOR TO DISASSEMBLY AND THE DEPOSITION ON THE ROTOR BODY SHOWED NO EVIDENCE OF DENATURATION TO INDICATE THAT IT WAS PRESENT DURING PUMP OPERATION, SUGGESTING THAT THE OBSERVED DEPOSITIONS DID NOT DEVELOP WHILE THE PUMP WAS SUPPORTING THE PATIENT. EXAMINATION OF THE PUMP BEARINGS, ROTOR, AND BLOOD CONTACTING SURFACES DID NOT REVEAL ANY ANOMALIES. ELECTRICAL CONTINUITY TESTING OF THE RETURNED PORTION OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. FUNCTIONAL TESTING OF THE PUMP UNDER NORMAL OPERATING CONDITIONS REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES COMPARABLE TO THE DATA RECORDED DURING THE MANUFACTURING PROCESS. THE PUMP OPERATED 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.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 1 YEAR AND 3 MONTHS. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT ON AN UNSPECIFIED DATE, THE PATIENT HAD ELEVATED LACTATE DEHYDROGENASE AND PLASMA FREE HEMOGLOBIN LEVELS. PUMP THROMBUS WAS SUSPECTED. THE PATIENT ALSO SUFFERED A HEMORRHAGIC STROKE, DEVELOPED SEPTIC SHOCK AND MULTI-ORGAN SYSTEM FAILURE AND SUBSEQUENTLY EXPIRED IN THE HOSPITAL. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430648 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death