MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSISST) BYPASS

Model Number 106524INT

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Chest Pain (1776); Myocardial Infarction (1969); Thromboembolism (2654)

Event Date 02/26/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that the patient complained of severe chest paid which irradiated to the shoulder around 21:15 pm on (b)(6) 2022.The patient was unstable and low flow alarms and left ventricular assist device (lvad) fault alarms occurred at 21:30.Log files were sent for review and the patient's primary system controller captured the onset of low flow estimates as well as low flow hazards on (b)(6) 2022 from 00:25-21:40.The pump speed was at 4700 rpm with a pulsatility index (pi) of 9.2, power of 3.0 w, and flow of 0.0 lpm.The flow rose to 1.5 to 2 lpm with a speed of 4800 rpm, pi of 2.5, and power of 2 w.The patient was unresponsive, was intubated, and pediatric advanced life support (pals) was initiated.Systolic blood pressure was above 80 mmhg and the patient's mean arterial pressure (map) was above 65.The patient remained unresponsive and norepinephrine was started by the code team but no pulse was felt while the map was 72.The patient was prepared and shifted to the intensive care unit (icu) with the cardiac and code team.An echocardiogram was ordered and transcutaneous pacing was started with good capture (an external pacemaker was not capturing at the beginning of the event).A transthoracic echocardiogram (tee) showed a massive thrombus formation out of the left atrium and left ventricle not taken in the pump.The system controller was changed around 21:38-21:42 in an attempt to clear the low flow alarms.However, the intermittent low flow alarms were ultimately attributed to bradycardia associated with arrhythmias.Log files showed that the driveline was disconnected at 21:40-21:49 with pump off alarms and a controller shut down.Log file analysis of the backup system controller showed low flow hazards on (b)(6) 2022 from 21:48-22:44.The driveline was disconnected at 22:44-22:47 pm with a pump off and controller shut down.The pump was reconnected to the primary system controller at 22:45-23:34 and regained speed with continued low flow hazard alarms.The driveline was disconnected for a second time 23:34-23:36 with a pump off and controller shut down.The pump was reconnected again to the backup controller and regained set speed from 23:32 on (b)(6) 2022 to 00:22 on (b)(6) 2022.Low flow hazards continued.A second driveline disconnect was noted on the backup controller at 00:22, after which the pump was briefly reconnected and regained set speed.The low flow hazard alarms continued.A third driveline disconnect was noted at 00:23 with a pump off after which the pump was reconnected and regained set speed.The low flow hazard alarms continued.A fourth driveline disconnect was noted at 01:02-01:32 with a pump off and controller shut down.Throughout all of this the patient was still unstable and in very ill condition and extracorporeal membrane oxygenation (ecmo) was placed.The patient ultimately passed away on (b)(6) 2022 due to acute myocardial infarction.The death was not considered to be device related.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported events and patient outcome could not be conclusively established through this evaluation.Additionally, review of the submitted log files confirmed multiple pump stops which appeared to be associated with driveline disconnect events.A specific cause for the driveline disconnects could not conclusively be determined through this evaluation.The controller event log files were retrieved from the patient¿s main and backup system controllers and collectively contained relevant data from (b)(6) 2022 12:57:07 through (b)(6) 2022 01:32:45, per the timestamps.Low flow faults were captured throughout the files, when the estimated flow dropped below the low flow threshold of 2.5 lpm.Estimated flow initially fluctuated between 1.2-1.9 lpm, but then rapidly dropped to 0.0 lpm on (b)(6) 2022, resulting in persistent low flow hazard alarms.The driveline was disconnected from the main and backup system controllers multiple times between 21:40:42 and 23:34:44 on (b)(6) 2022.Although a specific cause for these events could not be conclusively determined through this evaluation, they appeared to be consistent with the report of the vad coordinator switching system controllers to attempt to clear the low flow alarms.Additional driveline disconnect events were captured at 00:22:57 and 00:23:33 on (b)(6) 2022, which caused the pump to stop.These events lasted approximately 19 and 9 seconds, respectively, and were both associated with power b broken, power a broken, com b fault, com a fault, and low pump current faults flags, as well as low flow, driveline disconnect, and lvad off alarms.Following the reconnection of the driveline each time, estimated flow remained at 0.0 lpm, resulting in continuous low flow hazard alarms.At 01:02:43 on (b)(6) 2022, the driveline was disconnected from the backup system controller for the final time.This was followed by the disconnection of the black and white power cables.The driveline was not reconnected to either system controller following this time stamp.Despite the observed events, the pump appeared to function as intended while the driveline was connected.It was reported that hm3 lvas, serial number (b)(6), was not explanted and would not be 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 implant kit was shipped on 17sep2020.The hm3 lvas ifu is currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events including, cardiac arrhythmia, peripheral thromboembolic event, and death, that may be associated with the use of the heartmate 3 left ventricular assist system.Section 1 also addresses all pump parameters.Section 2 "system operations" (under "system controller warnings and cautions") states, "check the system controller driveline connector to confirm that the driveline is securely inserted in the socket.If the driveline disconnects from the system controller, the pump stops.If the driveline disconnects from the system controller, promptly reconnect it to resume pump operation." section 2 also contains a section titled "connecting the driveline to the system controller", which provides instructions on connecting/disconnecting the driveline to/from the system controller and making sure that it is fully and properly inserted into the system controller socket.Section 4 of the ifu, ¿system monitor¿, describes the pump flow display and the hazard alarms.Per design, when the estimated flow value is calculated at less than 2.5 lpm, a low flow status is posted to the log file.If the flow remains below 2.5 lpm for 10 seconds, a low flow hazard alarm is triggered.Section 4 also explains that changes in patient condition can result in low flow.Section 6 of the ifu, ¿patient care and management¿, lists arrhythmia and thromboembolism as potential late postimplant complications.Section 6 of the ifu, under ¿anticoagulation¿, provides information regarding the recommended anticoagulation regimen, including inr values, as well as suggested anticoagulation modifications.Section 7 of the ifu, "alarms and troubleshooting", addresses all system alarm conditions as well as the appropriate actions associated with each condition.The hm3 lvas patient handbook is also currently available.The patient handbook warns in several sections: "check the system controller driveline connector often to confirm that the driveline is securely inserted in the socket.If the driveline disconnects from the system controller, the pump will stop." and "the pump will stop if the driveline is disconnected from the system controller.If the driveline disconnects from the system controller, reconnect it right away to restart the pump.The pump cannot run without power." in addition, the patient handbook states, "call your hospital contact if you think that, for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment." the patient handbook also contains a section on handling emergencies.Section 5 ¿alarms and troubleshooting¿ contains information regarding all system controller alarms, including the driveline disconnected hazard alarm, and the proper actions associated with them.A section on ¿handling emergencies¿ is also provided in this document.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) 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: 13900346
• MDR Text Key: 287888006
• Report Number: 2916596-2022-01372
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/10/2022
• Device Model Number: 106524INT
• Device Lot Number: 7632547
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2020
• 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): Death; Life Threatening
• Patient Age: 11 YR
• Patient Sex: Female
• Patient Weight: 44 KG