BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)

    MDR report key: 16005956 · Received December 19, 2022

    Report

    Report Number
    2916596-2022-15500
    Event Type
    Injury
    Date Received
    December 19, 2022
    Date of Event
    November 30, 2022
    Report Date
    August 11, 2023
    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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION. THE REPORTED THROMBOSIS COULD NOT BE CONFIRMED THROUGH THIS EVALUATION AS NO IMAGES WERE SUBMITTED AND NO PRODUCT WAS RETURNED. ADDITIONALLY, A DIRECT CORRELATION BETWEEN HEARTMATE (HM) II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6),AND THE REPORT OF ELEVATED LACTATE DEHYDROGENASE (LDH) COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE SUBMITTED LOG FILE PRIMARILY CONSISTED OF PULSATILITY INDEX (PI) EVENTS. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED. THE PUMP APPEARED TO OPERATE AS INTENDED. THE PATIENT DENIED SHORTNESS OF BREATH OR OTHER HEART FAILURE SIGNS AND SYMPTOMS. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON HMII LVAS, SERIAL NUMBER (B)(6). NO FURTHER COMPLAINTS HAVE BEEN REPORTED AT THIS TIME. THE HEARTMATE II LVAS IFU, REV. C, LISTS DEVICE THROMBOSIS AND HEMOLYSIS AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. SECTION 1, ¿INTRODUCTION,¿ ADDRESSES ALL PUMP PARAMETERS, INCLUDING PI. SECTION 4, ¿SYSTEM MONITOR,¿ STATES THAT, ¿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. THIS DROP IN SPEED IS ACCOMPANIED BY A REDUCED PUMP FLOW. IF THE LOW SPEED LIMIT IS SET AT A VALUE ABOVE OR THE SAME AS THE FIXED SPEED SETPOINT, THE PUMP SPEED DOES NOT CHANGE DURING A PI EVENT. THERE ARE NO AUDIBLE ALARMS WITH A PI EVENT. PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. THESE EVENTS ARE ALSO REFERRED TO AS PI EVENTS, AND MAY BE INITIATED FOR REASONS OTHER THAN TRUE PI EVENTS. SOME REASONS INCLUDE SUDDEN CHANGES IN A PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. SECTION 6, "PATIENT CARE AND MANAGEMENT," SECTION PROVIDES INFORMATION ON ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES. THIS SECTION ALSO OUTLINES INDICATIONS OF PUMP THROMBOSIS, AS WELL AS HOW TO RESPOND TO SUCH EVENTS. 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 · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED THROMBOSIS COULD NOT BE CONFIRMED THROUGH THIS EVALUATION AS NO IMAGES WERE SUBMITTED AND NO PRODUCT WAS RETURNED. ADDITIONALLY, A DIRECT CORRELATION BETWEEN HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE FIRST SUBMITTED LOG FILE PRIMARILY CONSISTED OF PULSATILITY INDEX (PI) EVENTS. THE SECOND SUBMITTED LOG FILE CAPTURED SLIGHT, TRANSIENT ELEVATIONS IN PUMP POWER AND FLOW. SOME OF THE ELEVATIONS APPEARED TO BE CAPTURED DURING PI EVENTS. A SPECIFIC CAUSE FOR THESE ELEVATIONS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. NO OTHER NOTABLE EVENTS OR ALARMS WERE CAPTURED. THE PUMP APPEARED TO FUNCTION AS INTENDED AT THE FIXED SPEED THROUGHOUT BOTH LOG FILES. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINED ONGOING ON HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), UNTIL EXPIRING ON (B)(6) 2023. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WAS REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE II LVAS IFU (REV. C) IS CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, "INTRODUCTION", LISTS DEVICE THROMBOSIS, HEMOLYSIS, STROKE, AND BLEEDING AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. SECTION 1 ALSO PROVIDES AN EXPLANATION OF ALL PUMP PARAMETERS, INCLUDING PUMP POWER AND FLOW. 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. IN ADDITION, DEVICE FLOW AND POWER GENERALLY RETAIN A LINEAR RELATIONSHIP AT A GIVEN SPEED. THIS SECTION ALSO NOTES THAT ANY INCREASE IN POWER NOT RELATED TO INCREASED FLOW CAUSES ERRONEOUSLY HIGH FLOW READINGS. SECTION 4, ¿SYSTEM MONITOR,¿ STATES THAT, ¿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. THIS DROP IN SPEED IS ACCOMPANIED BY A REDUCED PUMP FLOW. IF THE LOW-SPEED LIMIT IS SET AT A VALUE ABOVE OR THE SAME AS THE FIXED SPEED SETPOINT, THE PUMP SPEED DOES NOT CHANGE DURING A PI EVENT. THERE ARE NO AUDIBLE ALARMS WITH A PI EVENT. PI EVENTS ARE ASSUMED BY THE SYSTEM DURING CASES WHEN THERE ARE SUDDEN AND SUBSTANTIAL CHANGES IN THE PULSATILITY INDEX. THESE EVENTS ARE ALSO REFERRED TO AS PI EVENTS AND MAY BE INITIATED FOR REASONS OTHER THAN TRUE PI EVENTS. SOME REASONS INCLUDE SUDDEN CHANGES IN A PATIENT¿S VOLUME STATUS, ARRHYTHMIAS, SUDDEN CHANGES IN POWER, AND SUDDEN CHANGES IN PUMP SPEED. SECTION 6, "PATIENT CARE AND MANAGEMENT," SECTION PROVIDES INFORMATION ON ANTICOAGULATION, INCLUDING RECOMMENDED INR VALUES. THIS SECTION ALSO OUTLINES INDICATIONS OF PUMP THROMBOSIS, AS WELL AS HOW TO RESPOND TO SUCH EVENTS. SECTION 6 ALSO EXPLAINS THAT PUMP PERFORMANCE IS SENSITIVE TO CHANGES IN SYSTEMIC VASCULAR RESISTANCE AND LEFT VENTRICULAR FILLING. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN AN ECHOCARDIOGRAM REVEALED A LIKELY THROMBUS. A REVIEW OF THE LOG FILE REVEALED 233 PULSATILITY INDEX (PI) OVER THE SPAN OF 18 HOURS. THERE WERE NO UNUSUAL EVENTS RECORDED IN THE LOG FILE EVENT HISTORY. THE PATIENT HAD ELEVATED LACTATE DEHYDROGENASE (LDH). THE PATIENT WAS ADMITTED TO THE HOSPITAL AND STARTED ON INTRAVENOUS BIVALIRUDIN. THE PATIENT WAS CONSIDERED NOT A PUMP EXCHANGE CANDIDATE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION REVEALED THAT THE PATIENT EXPERIENCED PUMP POWER AND FLOW ELEVATIONS WHICH WERE ATTRIBUTED TO A PUMP THROMBOSIS. THE PATIENT EXPERIENCED A RIGHT-SIDED ISCHEMIC CEREBROVASCULAR ACCIDENT WITH SUBSEQUENT HEMORRHAGIC CONVERSION. THE PATIENT WAS NOT A CANDIDATE FOR A THROMBECTOMY. THE PATIENT HAD THEIR ANTICOAGULATION MEDICATION REVERSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1808104 HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106015 6152097 00813024011224

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention| H