BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 10816437 · Received November 10, 2020

    Report

    Report Number
    2916596-2020-05351
    Event Type
    Injury
    Date Received
    November 10, 2020
    Date of Event
    October 22, 2020
    Report Date
    December 17, 2020
    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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED SHORTNESS OF BREATH (SOB), AND A DIRECT CORRELATION TO HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER: (B)(6), COULD NOT CONCLUSIVELY BE ESTABLISHED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILE CAPTURED A FEW TRANSIENT ELEVATIONS IN PUMP POWER AND CALCULATED FLOW THAT WERE CAPTURED DURING PULSATILITY INDEX (PI) EVENTS. OF NOTE, THE LOG FILE'S DATA LOGGER DID NOT REVEAL ANY POWER OR FLOW ELEVATIONS. ADDITIONALLY, NO NOTABLE ALARMS WERE ACTIVE IN THE LOG FILE. PUMP SPEED REMAINED ABOVE THE LOW SPEED LIMIT, AND THE SYSTEM APPEARED TO BE OPERATING AS INTENDED. THE PATIENT REMAINS ONGOING ON HEARTMATE II LVAS, SERIAL NUMBER: (B)(6), AND NO RELATED COMPLAINTS HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE II LVAS INSTRUCTIONS FOR USE (IFU) EXPLAINS THAT PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. IF THE SYSTEM DETECTS A PI EVENT, THE PUMP SPEED AUTOMATICALLY DROPS TO THE LOW SPEED LIMIT AND SLOWLY RAMPS BACK UP AT A RATE OF 100 RPM PER SECOND TO THE FIXED SPEED SETPOINT. SOME REASONS FOR PI CHANGES INCLUDE SUDDEN CHANGES IN THE PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), REV. C AND THE HEARTMATE II PATIENT HANDBOOK, REV. C ARE CURRENTLY AVAILABLE. ALTHOUGH THE ACCOUNT REPORTED THAT THE PATIENT DID NOT EXPERIENCE HEMOLYSIS, SECTION 1 OF THE IFU, ¿INTRODUCTION¿, LISTS HEMOLYSIS AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. SECTION 6, ¿PATIENT CARE AND MANAGEMENT¿ (UNDER ¿ANTICOAGULATION¿), PROVIDES INFORMATION REGARDING THE RECOMMENDED ANTICOAGULATION THERAPY AND INR RANGE, AS WELL AS SUGGESTED ANTICOAGULATION MODIFICATIONS. SECTION 1 OF THE IFU ALSO ADDRESSES ALL PUMP PARAMETERS INCLUDING PUMP SPEED, POWER, FLOW, AND PULSATILITY INDEX (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. ADDITIONALLY, SECTION 6, UNDER ¿PUMP PERFORMANCE MONITORING¿, EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. SECTION 4 OF THE IFU EXPLAINS THAT IF THE SYSTEM DETECTS A PI EVENT, THE PUMP SPEED WILL AUTOMATICALLY REDUCE TO THE LOW SPEED LIMIT AND SLOWLY RAMP BACK UP TO THE FIXED SPEED SETPOINT. PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHERE THERE IS A SUDDEN AND SUBSTANTIAL CHANGE IN PI. SOME REASONS FOR PI CHANGES INCLUDE SUDDEN CHANGES IN THE PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PUMP EXCHANGE DUE TO THROMBUS WAS REPORTED IN MFR REPORT #2916596-2020-04097. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED EARLY ON THE MORNING OF (B)(6) 2020 FOR SHORTNESS OF BREATH (SOB). THE PATIENT'S CONTROLLER WAS NOT ALARMING, NOR WAS IT DISPLAYING ANY NUMBERS THAT WERE OUT OF RANGE. THERE WERE NO SIGNIFICANT EVENTS UPON INTERROGATION. THE PATIENT HAD A RECENT PUMP EXCHANGE ON (B)(6) 2020 FOR THROMBUS AND IS KNOWN TO HAVE LACTATE DEHYDROGENASE (LDH) LEVELS GREATER THAN 1000 U/L AT BASELINE. THE MORNING OF (B)(6) 2020 THE PATIENT'S LDH WAS 1190 U/L. TECHNICAL SERVICES (TS) REVIEWED THE LOG FILE AND NOTED ELEVATED FLOWS ABOVE THE NORMAL PARAMETERS WHICH COULD BE CAUSED BY SOMETHING OBSTRUCTING THE PUMP. ADDITIONAL INFORMATION RECEIVED ON 27OCT2020 REPORTED THAT NO DIAGNOSTIC TESTING WAS PERFORMED TO IDENTIFY POTENTIAL THROMBUS BECAUSE THE PATIENT WAS ONLY ADMITTED FOR SOB. LOG FILES WERE SUBMITTED FOR PRECAUTIONARY MEASURES. NO HEMOLYSIS WAS IDENTIFIED, JUST FLUID OVERLOAD. THE PATIENT WAS GIVEN INTRAVENOUS (IV) MEDICATIONS TO RELEASE FLUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283845 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106015 7456811 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization