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

Model Number 106524US

Device Problems Disconnection (1171); Decreased Pump Speed (1500); Pumping Stopped (1503); Infusion or Flow Problem (2964)

Patient Problems Syncope (1610); Loss of consciousness (2418); Syncope/Fainting (4411)

Event Date 12/24/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the patient was admitted on (b)(6) 2020 with syncope and low flow alarms on their controller.Upon lvad interrogation, the low flows started at 12:18 on (b)(6) 2020.Then, at 12:32, there were low flow events in addition to no external power, pump off, and driveline disconnect events.At 12:33 there was additional no external power events in addition to more low flow alarms and a pump off event.Low speed advisories were also noted to have occurred at 12:33.The pump turned back on again at 12:34.Per the patient, he was at his house receiving low flow alarms on his controller and, at some point, he passed out.After he came to, the ambulance was there and transported him to the hospital via helicopter.Once in the helicopter, the patient denies any further low flow alarms.The patient stated that he never pulled out his driveline or disconnected both power leads.Technical services reviewed the event log and observed no external power alarms on (b)(6) 2020 at 12:31 that were associated with power cable disconnects on the white and black power leads where the controller was disconnected from batteries.The controller momentarily operated on its emergency backup battery (ebb)/power save mode.From 12:32:48-12:33:53, the controller recorded driveline disconnect/lvad off/intentional pump stop events where the driveline was momentarily disconnected from the controller.External power was restored to the controller at 12:33:47 when a fully charged battery was connected to the black power lead.The driveline was reconnected at 12:33:55.There were no other driveline disconnect events recorded in the file.The pump operated within set parameters for the remainder of the log, (b)(6) 2020 at 12:33:55pm through (b)(6) 2020 at 10:15:44 am.The event log also captured intermittent low flow events where the low flow estimator dropped below 1.5lpm.The low flow events seem to be a patient related issue and not an equipment related issue.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the submitted log files confirmed driveline disconnect alarms and low flow alarms; however, a direct cause for the events could not be conclusively determined through this evaluation.A correlation between heartmate 3 left ventricular assist device, serial number (b)(6), and the patient¿s syncope cannot be conclusively determined by this evaluation.The controller event log file contained data from (b)(6) 2020.The log file captured multiple transient low flow alarms throughout the file when the average flow rate decreased below the low flow threshold of 2.5 liters per minute (lpm) for 10 seconds or longer.On (b)(6) 2020, a no external power alarm became active that appeared to have been caused by disconnections of both power cables (refer to the system controller investigation).Within the same minute, the driveline was also observed to have been disconnected, thus stopping the pump.Once the driveline was reconnected and external power was restored to the system controller, the pump ramped back up to its set speed without issue.The log files appeared to capture the pump operating as intended.Multiple attempts for additional information regarding the event were sent to the account; however, no further information was provided.The patient remains ongoing on ventricular assist device (vad) support with no further related issues reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) and patient handbook explain that the pump will stop if the driveline is disconnected from the system controller.These documents also instruct the user to check the system controller driveline connector often to confirm that the driveline is securely inserted in the socket.The heartmate 3 lvas ifu also describes all alarm conditions, including the driveline disconnected and driveline power fault alarms, as well as the appropriate actions associated with them.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
• MDR Report Key: 11155631
• MDR Text Key: 226307018
• Report Number: 2916596-2021-00022
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/25/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7412130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 71 YR
• Patient Weight: 77