BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

    MDR report key: 8465519 · Received March 29, 2019

    Report

    Report Number
    2916596-2019-01425
    Event Type
    Injury
    Date Received
    March 29, 2019
    Date of Event
    February 22, 2019
    Report Date
    May 30, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011224
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER¿S INVESTIGATION CONCLUSION EVALUATION OF THE SUBMITTED LOG FILES CONFIRMED ELEVATIONS IN POWER AND ESTIMATED FLOW, FREQUENT PI EVENTS, AND ONE TRANSIENT LOW SPEED EVENT; HOWEVER, A DIRECT CORRELATION BETWEEN HEARTMATE II LVAS, SERIAL NUMBER (B)(4) AND THESE EVENTS COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. A SPECIFIC CAUSE FOR THESE LOG FILE FINDINGS COULD NOT BE DETERMINED THROUGH THIS EVALUATION. A DIRECT CORRELATION BETWEEN (B)(4) AND THE REPORTED ISCHEMIC STROKE AND GI BLEEDING COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILES CONTAIN DATA FROM (B)(6) 2019 AT 19:01 THROUGH (B)(6) 2019 AT 06:05 AND FROM (B)(6) 2019 AT 15:18 THROUGH (B)(6) 2019 AT 09:24. FREQUENT PI EVENTS WERE CAPTURED THROUGHOUT BOTH FILES. NO ATYPICAL TRENDS IN PUMP PARAMETERS WERE CAPTURED IN THE FIRST FILE. POWER AND ESTIMATED FLOW APPEARED TO INCREASE OVER THE DURATION OF THE SECOND FILE. FROM (B)(6) AT 19:21 THROUGH THE END OF THE FILE, POWER RANGED FROM 9.7-19.1 W AND ESTIMATED FLOW RANGED FROM 9.8-12.0 LPM. THE MAJORITY OF ELEVATIONS IN POWER AND ESTIMATED FLOW APPEARED TO BE ASSOCIATED WITH PI EVENTS. THE PUMP SPEED REMAINED ABOVE THE LOW SPEED LIMIT UNTIL (B)(6) AT 04:14:15. AT THIS TIME THE PUMP SPEED WAS CAPTURED AT 9430 RPM (370 RPM BELOW THE LOW SPEED LIMIT) WHILE THE SYSTEM WAS CONNECTED TO THE POWER MODULE. THE LOW SPEED OPERATION FLAG WAS ACTIVE DURING THIS EVENT. POWER WAS 15.1 W AND A PI EVENT WAS CAPTURED AT THIS TIME; HOWEVER, THE PUMP SPEED QUICKLY RECOVERED ABOVE THE LOW SPEED LIMIT. NO ATYPICAL ALARMS WERE CAPTURED AND THE PUMP SPEED REMAINED ABOVE THE LOW SPEED LIMIT FOR THE REMAINDER OF THE FILE. THE HEARTMATE II LVAS INSTRUCTIONS FOR USE (IFU) LISTS STROKE AND BLEEDING AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM AND OUTLINES THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE. IN REFERENCE TO POWER, THIS IFU 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. IN REFERENCE TO FLOW, THIS IFU EXPLAINS THAT DEVICE FLOW AND POWER GENERALLY RETAIN A LINEAR RELATIONSHIP AT A GIVEN SPEED. HOWEVER, WHILE POWER IS DIRECTLY MEASURED BY THE SYSTEM CONTROLLER, THE REPORTED FLOW IS ESTIMATED, BASED ON POWER. THE IFU EXPLAINS THAT PI EVENTS MAY BE INITIATED FOR REASONS OTHER THAN TRUE SUCTION EVENTS. SOME REASONS INCLUDE SUDDEN CHANGES IN A PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER AND SUDDEN CHANGES IN PUMP SPEED. THESE TYPES OF PI EVENTS ARE MORE LIKELY TO BE TRIGGERED IN CASES OF LOW PULSATILITY. ADDITIONALLY, THE IFU EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. THE IFU AND HEARTMATE II LVAS PATIENT HANDBOOK BOTH OUTLINE ALL SYSTEM CONTROLLER ALARMS AS WELL AS HOW TO RESPOND. THE PATIENT HANDBOOK ALSO INSTRUCTS THE USER TO ALWAYS CONNECT TO THE POWER MODULE WHEN SLEEPING (OR WHEN SLEEP IS LIKELY). A REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO DEVIATIONS FROM MANUFACTURING SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 2 YEARS AND 6 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON AN UNSPECIFIED DATE AND DURING ADMISSION PUMP POWERS BECAME SIGNIFICANTLY ELEVATED OVERNIGHT. THERE WAS NO CHANGE IN PUMP SPEED. SYSTEM CONTROLLER HISTORY INTERROGATION PERFORMED BY THE HOSPITAL CLINICIAN REVEALED PUMP POWER REACHED 19.1 W DURING A PI EVENT, WHICH WAS REPORTED AS EXCESSIVE. THE PATIENT WAS ON A CONTINUOUS ARGATROBAN INFUSION FOR ANTICOAGULATION ¿ PARTIAL THROMBOPLASTIN TIME (PTT) VALUES WERE CONSISTENTLY IN THE 60-80 SECOND RANGE. PLASMA-FREE HEMOGLOBIN DRAWN AT THE FIRST SIGN OF THE ELEVATED PUMP POWER WAS LESS THAN 8 MG/DL. BLOOD WORK WAS REPORTED AS NORMAL, AND CONSISTENT WITH PATIENT¿S BASELINE. PATIENT¿S HEARTRATE AND DOPPLER MEAN ARTERIAL PRESSURE (MAP) WERE WITHIN NORMAL LIMITS WITH MAP CONSISTENTLY 80-90 MMHG. REVIEW OF THE SUBMITTED LOG FILE BY TECHNICAL SERVICES CONFIRMED THE ELEVATED PUMP POWER AND ELEVATED PUMP FLOW WHICH REMAINED ELEVATED. IT WAS REPORTED THAT DURING THIS ADMISSION THE PATIENT HAD GASTROINTESTINAL (GI) BLEED THAT MAY HAVE CONTRIBUTED TO THE PI EVENTS OBSERVED. WITH REGARDS TO THE ELEVATED PUMP POWER, THE PATIENT REPORTEDLY NEVER SHOWED SIGNS OF HEMOLYSIS. LACTATE DEHYDROGENASE (LDH) AND PLASMA-FREE HEMOGLOBIN REMAINED NORMAL THROUGHOUT HOSPITALIZATION. ON (B)(6) 2019 THE PATIENT EXPERIENCED A SMALL ISCHEMIC CEREBROVASCULAR ACCIDENT (CVA,) FIVE DAYS AFTER ELEVATED PUMP POWER WAS NOTED. THE PATIENT DID NOT HAVE ANY RESIDUAL SIDE EFFECTS AND WAS ULTIMATELY DISCHARGED ON (B)(6) 2019. VAD PARAMETERS REPORTEDLY RETURNED TO PATIENT¿S BASELINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259739 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 106015 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| L