MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSIST) BYPASS

Model Number 106524

Device Problems Pumping Stopped (1503); Electro-Static Discharge (2149); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Cognitive Changes (2551); Ischemia Stroke (4418); Drug Resistant Bacterial Infection (4553)

Event Date 01/12/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported on (b)(6) 2022 that the patient passed away on (b)(6) 2022 in the intensive care unit (icu) after being transitioned to comfort care.The patient had initially been found unresponsive by his spouse and was transferred to the facility on (b)(6) 2022.It was found that the patient had experienced an ischemic cerebrovascular accident (cva).The patient also had a multi-drug resistant pseudomonas infection, cognitive decline, and increased functional impairment with loss of independence.The patient's family ultimately decided to withdraw care.

Manufacturer Narrative

Section a: patient date of birth and patient weight were requested but not provided.Manufacturer's investigation conclusion.A technical services review revealed that the data showed 1 pump stop that lasted 3 seconds on (b)(6) 2022.It was thought that this was due to electrostatic discharge which caused the pump to stop and restart.The patient also began to have persistent low flow alarms on (b)(6) 2022.Evaluation of the submitted log files revealed that on (b)(6) 2022 at 11:59:46 there were com a, com b, low pump current, low speed advisory, low speed hazard, and pump stop fault flags when the speed of the pump abruptly became 0 rpm.The pump stop lasted 3 seconds.During the event, the pump speed reduced to 0 rpm and the low speed, low flow, com b, and pump stop faults were activated.At this time, the pump flow began to drop below the low flow threshold of 2.5 lpm to as low as 0.2 lpm, triggering low flow fault flags.By 11:59:55 on (b)(6) 2022, the speed of the pump returned to above the low-speed limit, and the patient regained normal parameters.Throughout the rest of the log file there were 77 low flow fault flags that were triggered when the estimated flow dropped below the low flow threshold of 2.5 lpm, to as low as 1.3 lpm.Of these faults, 42 lasted over 10 seconds and low flow alarms were triggered.Based on the reported events, this pump stop appeared to be cause by a potential electrostatic discharge event.The pump operated as intended at the set speed for the remainder of the log file following the esd event.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.No product is available for investigation.Heartmate 3 lvas ifu, rev.C, and the heartmate 3 lvas patient handbook, rev.D, are currently available.Heartmate 3 instructions for use outlines all system alarms, including the lvad fault advisory, and the recommended actions associated with these events in the alarms and troubleshooting section.Section 6 of the hm3 ifu, "patient care and management" (under "postoperative patient care"), warns that static electricity can cause the lvad to stop and explains how it can be avoided.Section 6 (under "electrostatic discharge") explains that strong static discharges should be avoided.Additionally, the safety testing and classification tables in appendix c of this document include electrostatic discharge information.Section 7 "alarms and troubleshooting" describes all alarm conditions as well as the appropriate actions associated with them.Section 1 of the hm3 patient handbook, (under "general warnings"), warns the user: do not touch television (tv) or computer screens while you have the pump.Tv and computer screens have strong static electricity.A strong electrical shock can damage electrical parts of the system and cause the pump to stop.Avoid activities and conditions that may induce strong static discharges (for example, touching a television or computer monitor screen) as electrostatic discharges may damage and/or interfere with the electrical parts of the system, and may cause the lvad to perform improperly or stop.Section 4 "living with the heartmate 3" contains a section on "static electricity", in which the user is warned to avoid activities that may cause static electricity and to discharge any built up esd by touching a metal surface before handling lvas components.Additionally, the testing & classification tables in section 9 of this document include electrostatic discharge.Section 2 ¿system operations¿ instructs the user to use the system monitor to reset the system controller clock and to make sure the system monitor clock is correct before relying on it.Section 4 entitled ¿system monitor¿ explains that the low flow hazard alarm is triggered when pump flow is less than 2.5 lpm, the pump has stopped, the pump is not operating properly, or the driveline is disconnected from the system controller.A 10-second delay is imposed between the detection of the low flow status and the activation of the associated audio and visual indicators on the system controller.Changes in patient conditions can result in low flow, such as hypertension.Section 7 entitled ¿alarms and troubleshooting¿ explains all system alarms and the recommended actions associated with them.This document advises the user to 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.This handbook also explains that the pump will stop if the driveline is disconnected from the system controller.If the driveline disconnects from the system controller, promptly reconnect it to restart the pump.The pump cannot run without power.Section 5 contains information regarding all system alarms and the recommended actions associated with them.Section 7 of the ifu, "alarms and troubleshooting", and section 5 of the patient handbook, "alarms and troubleshooting", address all system alarm conditions as well as the appropriate actions associated with each condition.Furthermore, section 8 of the patient handbook, ¿handling emergencies¿, also provides examples of emergencies and the proper actions to take in the event an emergency occurs.Section 1, ¿introduction,¿ lists death, infection (local, driveline, and pump pocket), and stroke as adverse events that may be associated with the use of the heartmate 3 lvas.Section 6, ¿patient care and management¿ (under ¿anticoagulation¿), provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.Section 6 of the ifu, ¿patient care and management¿, also lists infection as a potential late postimplant complication.Furthermore, several sections of the hm3 ifu and patient handbook provide care instructions regarding how to prevent infection as well as suggested responses in the event of infection.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 29mar2017.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• 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: 13500804
• MDR Text Key: 285364240
• Report Number: 2916596-2022-00668
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• 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: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2019
• Device Model Number: 106524
• Device Catalogue Number: 106524US
• Device Lot Number: 5922568
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2017
• 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; Death
• Patient Age: 80 YR
• Patient Sex: Male