MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSIST) BYPASS

Model Number 106015

Device Problems Mechanical Problem (1384); Decreased Pump Speed (1500); Pumping Stopped (1503)

Patient Problems Thrombosis/Thrombus (4440); Lactate Dehydrogenase Increased (4567)

Event Date 10/12/2023

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported that log files were submitted for review.The patient was admitted on (b)(6) 2023 for concern of elevated lactate dehydrogenase (ldh) levels and power spikes presumed to be due to transient pump thrombosis.The patient was given heparin and cangrelor infusions.The increased ldh and power spikes resolved.The patient remained admitted.

Event Description

It was reported that ldh levels were greater than 2000 international units/liters (iu/l) on admission, and power spikes presumed to be due to transient pump thrombosis.Treatment also included a catheter directed tissue plasminogen activator (tpa) at thrombus location, and the ldh level trended down to under 1000 iu/l following treatment.It was noted that the patient did not wish for aggressive therapy.A ramp echocardiogram (echo) was performed, and no notable findings were identified.The patient's dose of aspirin was increased to 325 mg.The patient was also given plavix (clopidogrel) and continued warfarin.There was no active bleed reported.There were no changes to patient condition or anticoagulation status that may have contributed to the pump thrombosis.A submitted event log captured more power and flow elevations on (b)(6) 2023 and (b)(6) 2023.Additional log file review showed speed drops lower than the low speed limit on (b)(6) 2023 and (b)(6) 2023.Subsequent log files were submitted for urgent review that captured multiple low flow alarms and a pump stop event on (b)(6) 2023.The event log files also captured several power and flow elevations on (b)(6) 2023 and (b)(6) 2023.There were no active alarms until the morning of (b)(6) 2023.The patient experienced 11 low speed advisory alarms and another pump stop alarm on (b)(6) 2023.These events appeared to have occurred while connected to the power module.The patient started to use an ungrounded cable for wall power connection and external batteries.The mechanical circulatory support equipment operated as intended.The patient was stable in the hospital.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted log files confirmed low speed and pump stop events, which appeared to be consistent with a potential issue with the driveline.The log file review also confirmed elevations in pump power and flow; however, a specific cause for these events could not be conclusively determined through this evaluation.The reported suspected pump thrombus could not be confirmed.A direct correlation between the device and the reported parameter changes and elevated lactate dehydrogenase (ldh), as well as a direct correlation between the suspected thrombus and these reported events could not be conclusively established.The submitted log files captured transient elevations in pump power and estimated flow on (b)(6) 2023.Of note, these elevations were captured during pulsatility index (pi) events.The pump was operating as intended at the set speed during these events.Additionally, several low speed and one pump stop event were observed on (b)(6) 2023.While the patient was supported by the power module or by both the power module and battery power.Based on previous complaint history, the captured low speed and pump stop events appeared consistent with potential driveline wire compromise.The patient remains ongoing on heartmate ii left ventricular assist system (lvas), (b)(6).No further related events have been reported at this time.The relevant sections of the device history records for (b)(6) and the driveline were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) rev.C and the heartmate ii lvas patient handbook rev.C are currently available.Section 1 of the ifu lists device thrombosis and hemolysis as adverse events which may be associated with the use of heartmate ii lvas.This section 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.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.Sections 4 of the ifu explains that pi events are assumed by the system during cases when there are sudden and substantial changes in the pulsatility index.These events may be initiated for reasons other than true pi events, including sudden changes in the patient¿s volume status, arrhythmias, sudden changes in power, and sudden changes in pump speed.Section 6 of the ifu lists thromboembolism as a potential late postimplant complication.This section, under ¿anticoagulation", provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.Additionally, this section, under "pump performance monitoring", explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.Sections 6 and 8 of the ifu, as well as sections 4 and 6 of the patient handbook, provide information regarding how to clean and care for the driveline and address damage due to wear and fatigue of the driveline.These sections state that despite care, all heartmate ii drivelines have the potential for wire/shield breakdown to occur dependent on duration of use and movement/flexing over time.Additionally, these sections outline indications of driveline damage as well as the how to respond to such events.The patient handbook also instructs the user to call their hospital contact right away if the driveline is damaged (or might be damaged).Section 7 of the ifu and section 5 of the hmii patient handbook address all hazard and advisory alarms, as well as how to respond to each alarm condition.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Section d3, g1: updated information.Section d1: corrected.Section d4, catalog number: corrected.Section d4, lot number: corrected.Section d4, primary udi number: corrected.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17981440
• MDR Text Key: 326235308
• Report Number: 2916596-2023-07468
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2017
• Device Model Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 93 KG