BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8846160 · Received July 31, 2019

    Report

    Report Number
    2916596-2019-03486
    Event Type
    Injury
    Date Received
    July 31, 2019
    Date of Event
    July 3, 2019
    Report Date
    October 18, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011996
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE EVALUATION OF THE HEARTMATE II CONFIRMED INTERNAL DRIVELINE WIRE DAMAGE THAT COULD HAVE CONTRIBUTED TO THE PUMP STOP EVENTS CAPTURED IN THE SUBMITTED LOG FILE. THE PUMP WAS RETURNED ASSEMBLED WITH THE DRIVELINE (DL) CUT APPROXIMATELY 6¿ FROM THE PUMP HOUSING AND THE DISTAL PORTION OF THE DL WAS RETURNED MEASURING APPROXIMATELY 33.5¿. EVIDENCE OF A PREVIOUS DRIVELINE REPAIR WAS OBSERVED. THE INFLOW CONDUIT (INLET TUBE, FLEX SECTION, AND INLET ELBOW), OUTFLOW GRAFT, OUTFLOW GRAFT BEND RELIEF, AND BEND RELIEF COLLAR WERE NOT RETURNED. OUTFLOW ELBOW WAS RETURNED ATTACHED TO THE PUMP¿S OUTLET PORT. EVALUATION OF THE OUTFLOW ELBOW REVEALED NO EVIDENCE OF DEVELOPED DEPOSITIONS OR THROMBUS FORMATIONS. VISUAL EXAMINATION OF THE PUMP¿S BLOOD-CONTACTING SURFACES UPON DISASSEMBLY OF THE HEARTMATE II ALSO REVEALED NO EVIDENCE OF DEPOSITIONS OR THROMBUS FORMATIONS. CONTINUITY TESTING WAS PERFORMED ON THE PUMP END DL AND ALL WIRES WERE FOUND TO BE ELECTRICALLY INTACT. ELECTRICAL CONTINUITY TESTING WAS PERFORMED ON THE DISTAL END DL AND FOUND THAT THE BLACK WIRE PRODUCED AN OPEN CIRCUIT. THE PINS OF THE METAL CONNECTOR APPEARED FREE FROM DEFORMATION. THE SILICONE JACKET, BIONATE LAYER AND METAL BRAIDED SHIELD OF THE PUMP END DL APPEARED UNREMARKABLE. THE SILICONE JACKET OF THE DISTAL END DL APPEARED UNREMARKABLE; HOWEVER, A CUT WAS NOTED ON THE OUTER SILICONE LAYER OF THE DRIVELINE REPAIR. NO DAMAGE WAS OBSERVED UNDERNEATH THAT LAYER. THE SILICONE JACKET WAS THEN REMOVED, AND AN EXAMINATION OF THE BIONATE AND SHIELDING REVEALED A HOLE IN THE BIONATE, APPROXIMATELY 32" FROM THE METAL CONNECTOR. THERE WAS ALSO SHIELD BREAKDOWN IN THIS AREA. THE SHIELDING AND BIONATE WERE REMOVED AND EXAMINATION OF THE UNDERLYING WIRES REVEALED THAT THE BLACK WIRE WAS FRACTURED, APPROXIMATELY 32" FROM THE METAL CONNECTOR. THE CONDUCTORS OF THIS WIRE WERE EXPOSED. ADDITIONAL BREACHES WERE ALSO OBSERVED ON THE RED, ORANGE, BROWN, YELLOW AND GREEN WIRES APPROXIMATELY 32¿ FROM THE METAL CONNECTOR. THE OBSERVED WIRE DAMAGE APPEARED TO BE THE RESULT OF FATIGUE FAILURE DUE TO REPETITIVE FLEXING OF THE DRIVELINE IN THIS AREA. MICROSCOPIC INSPECTION OF THE REMAINING WIRES APPEARED UNREMARKABLE AND BOTH DRIVELINE SEGMENTS WERE SUBMERGED IN A SALINE SOLUTION FOR HI-POT TESTING TO FURTHER VERIFY THE INTEGRITY OF EACH WIRE¿S INSULATION. THE TEST DID NOT REVEAL ANY ADDITIONAL BREACHES. THE HEARTMATE II OPERATES ON A THREE PHASE MOTOR WHERE EACH PHASE IS POWERED BY TWO REDUNDANT WIRES; THE YELLOW AND GREEN WIRES REPRESENT PHASE 1, THE BLACK AND BROWN WIRES REPRESENT PHASE 2, AND THE RED AND ORANGE WIRES REPRESENT PHASE 3. IF THE EXPOSED CONDUCTORS OF EITHER OF THE COMPROMISED WIRES CONTACTED THE BRAIDED SHIELD WHILE OPERATING ON A TETHERED POWER SOURCE (SUCH AS THE POWER MODULE), THE RESULTING ELECTRICAL SHORT TO GROUND WOULD HAVE CAUSED AN INTERRUPTION IN PUMP FUNCTION AND WOULD HAVE CONTRIBUTED TO THE PUMP STOP EVENTS WHILE SUPPORTED BY THE POWER MODULE CAPTURED IN THE SUBMITTED LOG FILE. AN INTERRUPTION IN PUMP FUNCTION COULD HAVE ALSO BEEN CAUSED BY A PHASE-TO-PHASE SHORT, WHICH WOULD OCCUR IF THE EXPOSED CONDUCTORS OF BOTH COMPROMISED WIRES MADE DIRECT CONTACT WITH EACH OTHER OR SIMULTANEOUS CONTACT WITH THE BRAIDED SHIELD WHILE OPERATING ON A TETHERED POWER OR ON BATTERY POWER. THE COMPLETELY FRACTURED CONDUCTORS OF THE BLACK WIRE WOULD HAVE ALSO CAUSED DRIVELINE FAULT ALARMS. THE HEARTMATE II LVAS IFU IS CURRENTLY AVAILABLE. PUMP SPEED, POWER, FLOW, AND PULSATILITY INDEX ARE ALSO ADDRESSED IN SECTION 1 OF THIS IFU. THIS IFU OUTLINES THE INDICATIONS OF PERCUTANEOUS LEAD DAMAGE, AS WELL AS HOW TO RESPOND TO SUCH EVENTS. THE ¿ALARMS AND TROUBLESHOOTING¿ SECTION OUTLINES ALL SYSTEM CONTROLLER ALARMS, AS WELL AS HOW TO RESPOND TO SUCH EVENTS. THE HEARTMATE II LVAS PATIENT HANDBOOK IS ALSO AVAILABLE. THIS DOCUMENT CONTAINS A SECTION ON ¿CARING FOR THE DRIVELINE¿ ¿ HOWEVER, ALL HEARTMATE II LVAD PERCUTANEOUS LEADS HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT UPON LENGTH OF USE MOVEMENT/FLEXING OVER TIME. THIS HANDBOOK CONTAINS IMPORTANT WARNINGS RELATED TO PUMP STOPS. NO ADDITIONAL INFORMATION 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) 2016. IT WAS REPORTED THAT THE PATIENT UNDERWENT PUMP EXCHANGE ON (B)(6) 2019. PER VAD COORDINATOR, THE PUMP EXCHANGE WAS DUE TO MULTIPLE AND FREQUENT PUMP STOPPAGES. THE PATIENT HAD AN EXTERNAL REPAIR LAST YEAR FOR A SHORT TO SHIELD. THE PUMP SHOULD'VE BEEN RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640241 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 107801 00813024011996

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention