BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8537191 · Received April 22, 2019

    Report

    Report Number
    2916596-2019-01982
    Event Type
    Injury
    Date Received
    April 22, 2019
    Date of Event
    August 9, 2018
    Report Date
    April 22, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011170
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE- 6 YEARS, 8 MONTHS. MANUFACTURER'S INVESTIGATION CONCLUSION: UPON EVALUATION OF THE DEVICE, A THROMBUS WAS FOUND WITHIN THE DEVICE. DAMAGE TO THE BIONATE AND SILICONE JACKET LAYERS OF THE DRIVELINE WAS ALSO CONFIRMED. THE DEVICE WAS RETURNED ASSEMBLED WITH THE DRIVELINE (DL) SEVERED APPROXIMATELY 9.5¿ FROM THE PUMP HOUSING. A DISTAL SEGMENT WITH THE CONTROLLER CONNECTOR WAS ALSO RETURNED MEASURING APPROXIMATELY 27¿ IN LENGTH. THE SEALED INFLOW CONDUIT (INLET TUBE, FLEX SECTION, AND INLET ELBOW) WAS RETURNED ATTACHED TO THE PUMP¿S INLET PORT. THE APICAL SEWING RING WAS RETURNED SECURED TO THE INLET TUBE WITH GREEN SUTURES. THE OUTLET ELBOW WAS RETURNED ATTACHED TO THE PUMP¿S OUTLET PORT. THE SEALED OUTFLOW GRAFT AND SEALED OUTFLOW GRAFT BEND RELIEF WERE RETURNED DETACHED FROM THE OUTLET ELBOW. EXAMINATION OF THE OUTLET ELBOW REVEALED A PINK, TISSUE-LIKE DEPOSITION THAT APPEARED TO BE SLIGHTLY ADHERED TO THE TEXTURED SURFACE. THE THROMBUS FORMATION LACKED ANY EVIDENCE OF LAMINATION OR DENATURATION. ALTHOUGH A SPECIFIC CAUSE FOR THE OBSERVED THROMBUS FORMATION COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, IT DID NOT APPEAR TO AFFECT PUMP FUNCTION AS THE PATIENT WAS ROUTINELY TRANSPLANTED. THE REMAINING BLOOD-CONTACTING SURFACES REVEALED NO EVIDENCE OF DEVELOPED DEPOSITIONS OR THROMBUS FORMATIONS. THE DISTAL 24¿ OF DRIVELINE WAS WRAPPED EXTENSIVELY IN WHITE TAPE. UNDERNEATH THE TAPE THERE WAS A SIGNIFICANT AMOUNT OF DISCOLORATION AND SHIELD BREAKDOWN. A CLAMSHELL REPAIR (COMPLAINT #61746; CS-031263; WO #39810) WAS PRESENT WHICH WAS COVERING FATIGUE DAMAGE TO THE BIONATE LAYER AND METAL BRAIDED SHIELD APPROXIMATELY 0.5¿ FROM THE CONTROLLER CONNECTOR. THE DAMAGE TO THE BIONATE APPEARED TO RESULT FROM WEAR FATIGUE DUE TO REPETITIVE FLEXING. A SPECIFIC CAUSE FOR THE OBSERVED DAMAGE TO THE SILICONE JACKET COULD NOT BE DETERMINED. ELECTRICAL CONTINUITY TESTING OF THE REPAIRED 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 THAT MET MANUFACTURING SPECIFICATION AND THE DEVICE FUNCTIONED AS INTENDED. THE HEARTMATE II LVAS IFU LISTS DEVICE THROMBOSIS AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. SECTION 1 ¿INTRODUCTION¿ PROVIDES AN EXPLANATION OF EACH PUMP¿S PARAMETERS. SECTION 6 ¿PATIENT CARE AND MANAGEMENT¿ OUTLINES INDICATIONS OF PUMP THROMBOSIS AND HOW TO RESPOND TO SUCH EVENTS. SECTION 6 ALSO OUTLINES THE SUGGESTED ANTICOAGULATION THERAPY AND INR RANGE DURING USE OF THE HEARTMATE II LVAS. THE IFU ALSO PROVIDES INSTRUCTIONS FOR DEVICE IMPLANTATION INCLUDING HOW TO PROPERLY INSERT THE INFLOW CONDUIT. THE OPENING OF THE SEALED INFLOW CONDUIT SHOULD BE DIRECTED TOWARD THE MITRAL VALVE AND AWAY FROM THE INTERVENTRICULAR SEPTUM. ADDITIONALLY, PRIOR TO ADVANCING THE INLET EXTENSION INTO THE LEFT VENTRICLE THROUGH THE APICAL SEWING RING, THE USER IS INSTRUCTED TO REMOVE THE GLOVE TIP FROM THE SEALED INFLOW CONDUIT AND THE CENTERING FIXTURE FROM THE APICAL SEWING RING AND TO INSPECT THE VENTRICLE AND REMOVE ANY PREVIOUSLY FORMED CLOTS THAT MAY CAUSE EMBOLISM OR ANY TRABECULAE THAT MAY IMPEDE FLOW. THE IFU STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5 LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. THIS IFU ALSO OUTLINES THE INDICATIONS OF DRIVELINE DAMAGE, AS WELL AS HOW TO RESPOND TO SUCH EVENTS. THE SECTION ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ CONTAINS INFORMATION REGARDING ALARMS ON THE SYSTEM CONTROLLER AND THE PROPER ACTIONS ASSOCIATED WITH THEM. 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 (LVAD) ON (B)(6) 2011. IT WAS REPORTED THE PATIENT UNDERWENT A ROUTINE TRANSPLANT. DURING EVALUATION OF THE DEVICE, A THROMBUS WAS FOUND WITHIN THE DEVICE AS WELL AS DAMAGE TO THE BIONATE AND SILICONE JACKET LAYERS OF THE DRIVELINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329932 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 104911 00813024011170

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Other