BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3962670 · Received July 16, 2014

    Report

    Report Number
    2916596-2014-01192
    Event Type
    Injury
    Date Received
    July 16, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE REPORT OF A SUSPECTED THROMBUS WAS CONFIRMED BASED ON THE PHOTO SUBMITTED TO THE MANUFACTURER AND THE EVALUATION OF THE RETURNED HEARTMATE II LVAD. A PHOTO OF THE REPORTED THROMBUS THAT WAS FOUND WHEN THE PUMP WAS DETACHED FROM THE INFLOW CONDUIT WAS SUBMITTED; HOWEVER, THE DEPOSITIONS ORIGIN, HOW IT DEVELOPED, OR THE AMOUNT OF TIME THAT IT WAS PRESENT WHILE THE PUMP WAS OPERATING COULD NOT BE CONCLUSIVELY DETERMINED. UPON DISASSEMBLY OF THE RETURNED PUMP, THE EXAMINATION OF THE OUTLET STATOR REVEALED A NON-LAMINATED DEPOSITION SITUATED IN BETWEEN THE OUTLET BEARING BALL AND THE STATOR BLADES. THE LACK OF LAMINATED LAYERING SUGGESTS THAT THE DEPOSITION DID NOT DEVELOP IN THE OUTLET STATOR. IN ADDITION, THERE WAS NO EVIDENCE OF DENATURING OR CONTACT MARKS ON THE OUTLET SECTION OF THE ROTOR TO INDICATE THAT THE DEPOSITION WAS PRESENT WHILE THE PUMP WAS OPERATING. THE EXAMINATION OF THE REMAINING PUMP BLOOD-CONTACTING SURFACES REVEALED NO DEPOSITIONS AND THE EXAMINATION OF THE PUMP BEARINGS, ROTOR, AND BLOOD-CONTACTING SURFACES UNDER A MICROSCOPE, REVEALED NO ABNORMALITIES. IF THE DEPOSITION FOUND IN THE OUTLET STATOR AND THE DEPOSITION FROM THE SUBMITTED PHOTO WERE PRESENT FOR AN EXTENDED AMOUNT OF TIME WHILE THE PUMP WAS SUPPORTING THE PATIENT, THEY WOULD HAVE CONTRIBUTED TO THE REPORTED ELEVATION IN LACTASE DEHYDROGENASE. THE PUMP WAS CLEANED, REASSEMBLED AND FUNCTIONALLY TESTED UNDER LOADED CONDITIONS USING A MOCK CIRCULATORY LOOP AND THE PUMP WAS FOUND TO FUNCTION 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

    THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED A NECROTIC BOWEL AND DID NOT SURVIVE. SUPPORT WAS WITHDRAWN FROM THE PATIENT. THE PUMP WAS NOT EXPLANTED AND AN AUTOPSY WAS NOT PERFORMED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT, APPROXIMATELY FIVE DAYS POST IMPLANTATION OF THE LVAD, THE PT CONTINUES TO HAVE "--- "FOR FLOW READING, NOW PRESENTING WITH INCREASED LACTATE DEHYDROGENASE (LDH) GREATER THAN 2,000. PER VAD COORDINATOR, THE LEFT VENTRICLE APPEARS UNLOADED ON ECHO. A COMPUTED TOMOGRAPHY (CT) ANGIOGRAM WAS CONDUCTED TO LOOK AT THE OUTFLOW GRAFT AND THE SURGEON STATED, "IT IS A THROMBUS IN THE PUMP, WHICH IS PARTIALLY RESOLVING NOW." THE THROMBUS ALGORITHM WAS REVIEWED BY THE SURGEON AND VAD COORDINATOR. ON (B)(6) 2014, A PUMP EXCHANGE WAS PERFORMED AND THROMBUS WAS CONFIRMED WHEN THE PUMP WAS DETACHED FROM THE INFLOW CANNULA. THE PT IS REPORTEDLY DOING MUCH BETTER NOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414975 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 141104

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention