BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6419817 · Received March 20, 2017

    Report

    Report Number
    2916596-2017-00583
    Event Type
    Death
    Date Received
    March 20, 2017
    Date of Event
    February 20, 2017
    Report Date
    August 17, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 2 YEARS, 7 MONTHS. A PORTION OF THE PERCUTANEOUS LEAD WAS RECEIVED 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.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: THE PUMP WAS NOT EXPLANTED FOLLOWING THE PATIENT'S EXPIRATION; HOWEVER, THE DISTAL END OF THE PATIENT'S PERCUTANEOUS LEAN (DRIVELINE) WAS RETURNED FOR EVALUATION. THE EVALUATION OF THE RETURNED PORTION OF THE DRIVELINE CONFIRMED AN ISSUE THAT WOULD HAVE CONTRIBUTED TO THE REPORTED PUMP STOPPAGE. APPROXIMATELY 23.5 INCHES OF THE EXTERNAL PORTION/DISTAL END OF THE DRIVELINE WAS RETURNED FOR EVALUATION. THE DISTAL END BEND RELIEF WAS NOTED TO BE SEPARATED FROM THE METAL CONNECTOR. ELECTRICAL CONTINUITY TESTING OF THE RETURNED PORTION OF THE DRIVELINE REVEALED THAT ALL WIRES WERE ELECTRICALLY INTACT. WHEN THE SEPARATED DISTAL END BEND RELIEF WAS PULLED BACK FROM THE METAL CONNECTOR, HOLES WERE IDENTIFIED IN THE CLEAR BIONATE LAYER ADJACENT TO THE METAL CONNECTOR, WHICH APPEARED CONSISTENT WITH MELTING AS A RESULT OF AN ELECTRICAL SHORT. BREAKDOWN OF THE METAL BRAIDED SHIELD CONSISTENT WITH OVER 2.5 YEARS OF USE WAS OBSERVED ALONG THE ENTIRE LENGTH OF THE DRIVELINE SEGMENT AND APPEARED MOST SIGNIFICANT NEAR THE METAL CONNECTOR. VISUAL INSPECTION OF THE UNDERLYING WIRES REVEALED THAT THE GREEN AND BLACK WIRES WERE PARTIALLY FRACTURED ADJACENT TO THE METAL CONNECTOR, EXPOSING THE INNER METAL CONDUCTORS. THE OBSERVED WIRE DAMAGE APPEARED TO BE THE RESULT OF FATIGUE FAILURE DUE TO REPETITIVE FLEXING OF THE DRIVELINE IN THIS AREA. MICROSCOPIC INSPECTION AND HIPOT TESTING OF THE RETURNED PORTION OF THE DRIVELINE DID NOT IDENTIFY ANY ADDITIONAL AREAS OF COMPROMISED WIRE INSULATION. IF THE EXPOSED CONDUCTORS OF EITHER OF THE COMPROMISED WIRES MADE CONTACT WITH THE BRAIDED SHIELD WHILE THE PATIENT WAS OPERATING ON A TETHERED POWER SOURCE SUCH AS THE POWER MODULE, THE RESULTING ELECTRICAL SHORT TO GROUND WOULD HAVE CAUSED THE REPORTED PUMP STOPPAGE RECORDED IN THE SYSTEM CONTROLLER LOG FILE. THE SYSTEM ALSO HAD THE POTENTIAL TO PRODUCE A PHASE-TO-PHASE SHORT, DURING WHICH AN INTERRUPTION IN PUMP FUNCTION COULD OCCUR IF THE EXPOSED CONDUCTORS OF THE TWO COMPROMISED WIRES MADE DIRECT CONTACT WITH EACH OTHER OR SIMULTANEOUS CONTACT WITH THE BRAIDED SHIELD WHILE OPERATING ON TETHERED POWER OR ON BATTERY POWER. 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 (LVAD) ON (B)(6) 2014. IT WAS REPORTED THAT ON (B)(6) 2017 AT APPROXIMATELY MIDNIGHT, THE PATIENT PRESENTED TO THE LOCAL EMERGENCY ROOM WITH CHEST PAIN. THE LVAD SYSTEM HAD ALSO BEEN PRODUCING ALARMS FOR OVER ONE HOUR. IT WAS DETERMINED THAT THE LVAD HAD BEEN OFF FOR AT LEAST ONE HOUR PRIOR TO ADMISSION AND IT WAS NOT RESTARTED. THE PATIENT WAS TRANSPORTED TO THE IMPLANTING CENTER AND PRIMACOR AND HEPARIN INFUSIONS WERE INITIATED. THE PUMP HAD BEEN OFF FOR OVER 3 HOURS UPON ARRIVAL AT THE IMPLANTING CENTER. THE SYSTEM CONTROLLER WAS DISCONNECTED FROM THE DRIVELINE AT APPROXIMATELY 3:30 AM ON (B)(6) 2017. VISUAL OBSERVATION OF THE DRIVELINE FOUND IT WAS TAPED AND WAS IN NEED OF A CLAMSHELL REPAIR, BUT REPORTEDLY THERE WERE NO OTHER AREAS OF OBVIOUS TRAUMA. THE PATIENT REMAINED WELL SUPPORTED ON INOTROPES AT THE TIME UNTIL A FURTHER PLAN OF CARE COULD BE DETERMINED. AN ECHOCARDIOGRAM SHOWED A DILATED LEFT VENTRICLE WITH AN ESTIMATED EJECTION FRACTION (EF) OF 10-15%. THE AORTIC VALVE OPENED WITH EVERY BEAT, AND LOW FLOWS WERE HEARD VIA DOPPLER THROUGH THE INFLOW CANNULA. THE PATIENT¿S INR WAS SUB-THERAPEUTIC AT 1.6, BUT OTHER LABORATORY VALUES WERE WITHIN NORMAL LIMITS, INCLUDING A LACTATE DEHYDROGENASE LEVEL OF 306 U/L, AND THERE WERE NO SIGNS OR SYMPTOMS OF HEMOLYSIS. X-RAYS IMAGES WERE REVIEWED BY THE MANUFACTURER'S TECHNICAL SERVICES REPRESENTATIVE AND SIGNIFICANT DAMAGE AT WAS OBSERVED AT THE DISTAL END BEND RELIEF AND NEAR THE SKIN EXIT SITE. A RIGHT HEART CATHETERIZATION REVEALED AN SVO2 OF 21% AND AN EF OF 10%. AN INTRA-AORTIC BALLOON PUMP WAS PLACED AND THE PATIENT WAS SCHEDULED TO UNDERGO A PUMP EXCHANGE ON (B)(6) 2017. IT WAS REPORTED THAT THE PATIENT WENT INTO CARDIAC ARREST ON (B)(6) 2017 IN THE EARLY MORNING PRIOR TO THE PLANNED PUMP EXCHANGE PROCEDURE AND EXPIRED. THE CAUSE OF EXPIRATION WAS REPORTED AS HYPOTENSION, ACIDOSIS AND HYPERKALEMIA. THE PUMP HAD BEEN OFF FOR APPROXIMATELY 24 HOURS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201928 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Death