BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 12174616 · Received July 15, 2021

    Report

    Report Number
    2916596-2021-03702
    Event Type
    Death
    Date Received
    July 15, 2021
    Date of Event
    June 20, 2021
    Report Date
    October 18, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE DEVICE AND PATIENT OUTCOME COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE RETRIEVED LOG FILE FROM SYSTEM CONTROLLER PCX-17855 CONTAINED DATA FROM 20:05:36 ON (B)(6) 2021 TO 18:24:37 ON (B)(6) 2021. THE PUMP¿S FIXED SPEED WAS SET TO 9200 ROTATIONS PER MINUTE (RPM) WITH A LOW SPEED LIMIT (LSL) OF 8800 RPM. PUMP POWER TYPICALLY RANGED FROM 5.5 ¿ 5.7 WATTS (W), AND FLOW TYPICALLY RANGED FROM 5.1 ¿ 5.5 LITERS PER MINUTE (LPM). THE FILE CAPTURED MULTIPLE PUMP STOPS AND LOW SPEED EVENTS ON (B)(6) 2021 WHILE THE PATIENT WAS BEING SUPPORTED BY BATTERY POWER. THERE WERE LOW SPEED HAZARD, LOW FLOW HAZARD, AND MOTOR STOPPED ALARMS ASSOCIATED WITH THE LOW SPEED/PUMP STOP EVENT CAPTURED ON (B)(6) 2021. IN ADDITION, STARTING AT 6:03:36 ON (B)(6) 2021, MULTIPLE LOW FLOW ALARMS WERE CAPTURED WHEN FLOW DECREASED BELOW 2.5 LPM WHILE THE PUMP WAS OPERATING AS INTENDED ABOVE THE LSL. THESE EVENTS APPEARED TO BE ASSOCIATED WITH THE PATIENT'S CONDITION AND OUTCOME. THE LOG FILE TERMINATES WITH THE DRIVELINE BEING DISCONNECTED, LEADING TO A PUMP STOP WHICH IS CONSISTENT WITH THE REPORT OF PUMP SUPPORT BEING DISCONTINUED. BASED ON PREVIOUS COMPLAINT EXPERIENCE, THE CAPTURED PUMP STOP AND LOW SPEED EVENTS APPEARED CONSISTENT WITH A POTENTIAL DRIVELINE ISSUE. NO AUTOPSY WAS PERFORMED, AND THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU) IS CURRENTLY AVAILABLE. SECTION 1, "INTRODUCTION," LISTS DEATH AS A POTENTIAL ADVERSE EVENT WHICH MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LVAS. SECTION 1 ALSO ADDRESSES ALL PUMP PARAMETERS INCLUDING PUMP SPEED, POWER, FLOW, AND PI. IN REFERENCE TO POWER, THIS SECTION EXPLAINS THAT PUMP POWER IS A DIRECT MEASUREMENT OF MOTOR VOLTAGE AND CURRENT; THEREFORE, CHANGES IN PUMP SPEED, FLOW, OR PHYSIOLOGICAL DEMAND CAN AFFECT PUMP POWER. THIS SECTION ALSO NOTES THAT ANY INCREASE IN POWER NOT RELATED TO INCREASED FLOW CAUSES ERRONEOUSLY HIGH FLOW READINGS. SECTION 4, ¿SYSTEM MONITOR,¿ PROVIDES MORE INFORMATION REGARDING ALL PUMP PARAMETERS AND DESCRIBES SITUATIONS WHICH MAY RESULT IN A LOW FLOW HAZARD ALARM, INCLUDING CHANGES IN PATIENT CONDITIONS. SECTION 6 OF THE HEARTMATE II IFU, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿PUMP PERFORMANCE MONITORING¿), EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. SECTION 6 (UNDER PUMP PERFORMANCE MONITORING), COVERS WEAR AND TEAR TO THE PERCUTANEOUS LEAD. SECTION 7, ¿ALARMS AND TROUBLESHOOTING,¿ ADDRESSES ALL SYSTEM CONTROLLER ALARMS (INCLUDING LOW FLOW HAZARD, LOW SPEED ADVISORY, AND PUMP OFF ALARMS) AND HOW TO RESPOND TO SUCH EVENTS. THE HEARTMATE II LVAS PATIENT HANDBOOK IS ALSO CURRENTLY AVAILABLE. THE PATIENT HANDBOOK CONTAINS A SECTION ON ¿CARING FOR THE DRIVELINE¿; HOWEVER, ALL HEARTMATE II LVAS DRIVELINES HAVE THE POTENTIAL FOR WIRE/SHIELD BREAKDOWN TO OCCUR DEPENDENT UPON LENGTH OF USE AND PATIENT HANDLING. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    DESCRIBE EVENT OR PROBLEM: HISTORY OF PHASE TO PHASE SHORT IS REPORTED IN MFR REPORT #2916596-2020-04692. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURERS INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS FOUND UNRESPONSIVE IN HIS CAR WITH HIS CONTROLLER ALARMING. EMERGENCY MEDICAL TECHNICIANS (EMT) DID NOT RECALL WHAT THE ALARM WAS, BUT ONLY THAT IT HAD STOPPED ALARMING ENROUTE TO THE NEAREST EMERGENCY ROOM. THE PATIENT REMAINED UNRESPONSIVE IN THE EMERGENCY ROOM, WHERE CLINICIANS WORKED TO GET RETURN OF CIRCULATION WITHOUT SUCCESS. THE PATIENT EXPIRED (B)(6) 2021. THE CAUSE OF DEATH WAS UNKNOWN. THE PATIENTS GLUCOSE AT TIME OF ADMISSION TO EMERGENCY WAS 30. VAD WAS WORKING AT TIME OF DEATH. IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF PHASE TO PHASE SHORT AND THAT THE CAUSE OF DEATH WAS COVID-19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073690 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death| L