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

Model Number 106524US

Device Problems Pumping Stopped (1503); Complete Loss of Power (4015)

Patient Problems Right Ventricular Dysfunction (2054); Heart Failure/Congestive Heart Failure (4446)

Event Date 12/16/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Reference mfr report number: 2916596-2020-06401.It was reported that the patient was sleeping on batteries and the batteries expired.At that point, the emergency backup battery engaged, but it too eventually expired.The patient's pump was off for an unknown amount of time before the patient woke up, walked to the mobile power unit (mpu), connected herself back to power, and the pump restarted.The patient denies hearing any alarms.Fortunately, the patient recovered left ventricular function with left ventricular ejection fraction (lvef) at 55% with aortic valve (av) opening, but has very poor right ventricular (rv) function.The patient thinks this happened on saturday night/sunday am, but it is difficult to tell by interrogation because the date was reset when the controller and pump lost power.The patient was educated on never sleeping on batteries and to always use the mpu.The vad coordinator demonstrated the alarm difference between being connected to battery power verses mpu as the mpu amplifies the alarms.The patient also understands to change to batteries in the mpu to ensure alarm function and will do this when she gets home.The patient denied any symptoms and her international normalized ratio (inr) has been therapeutic for a few months.Technical services (ts) reviewed the event log data and noted controller clock corrupt events and was unable to see when the battery depletion actually took place.Ts explained that the events described by the vad coordinator appear accurate, as the main reason for the clock to default to 1/1/2000 is total depletion of power resulting in the pump stopping.

Event Description

It was reported that the patient was doing fine and was not hospitalized.No changes were made to the patient's medical therapy.The patient had left ventricular recovery, but right heart function was reduced.This precludes the patient from lvad explant.

Manufacturer Narrative

Manufacturer's investigation conclusion: analysis of the submitted log files confirmed full depletion of the external batteries and the controller's internal backup battery leading to a pump off event.Additionally, a direct correlation between the device and the report of poor right ventricular function could not conclusively be determined through this evaluation.The submitted controller periodic log file contained data from on (b)(6) 2020 to on (b)(6)2000, as the controller clock had been interrupted by a pump off event.The log file shows the slow depletion of the external batteries, and then activation of the backup battery once the external batteries had been fully depleted.External power is then seen to have been restored, accompanied by controller_clock_corrupt alarms, showing that between the two periods the backup battery had been depleted completely, leading to a pump off event that would have led to the clock reset.The system appeared to function as intended.The patient remains ongoing on heartmate 3 (hm3) left ventricular assist system (lvas), serial number: (b)(6).No further related events have been 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) is currently available.Section 1 ¿introduction¿ provides an explanation of all pump parameters, including flow, and lists adverse events that may be associated with the use of the heartmate 3 left ventricular assist system, including right heart failure.Section 2 ¿system operations¿ states that the 11 volt lithium-ion backup battery should be used only for temporary support during a power-loss emergency.The backup battery inside the heartmate 3 system controller provides enough power to run the implanted heartmate 3 pump for at least 15 minutes if the main power source is disconnected or fails.Inappropriate use of the 11 volt lithium-ion backup battery may result in diminished run time during a power-loss emergency.Additionally, every heartmate 14 volt lithium-ion battery also has its own on-battery gauge.It shows the power level for that battery.Section 3 ¿powering the system¿ and section 6 ¿patient care and management¿ warn that the patient must always connect to the power module (pm) or mobile power unit (mpu) for sleeping or when there is a chance of sleep.A sleeping patient may not hear system controller alarms.These sections also warn not to use batteries to power the system when the patient is sleeping.Section 4 "system monitor" provides information about the pump flow display and the low flow hazard alarm condition.This section states that the low flow hazard alarm will be triggered when the estimated pump flow is less than 2.5 lpm, and also explains that changes in patient conditions can result in low flow.Section 6 ¿patient care and management,¿ which details the steps patients should take when going to sleep.These steps include switching to the pm or mpu and states that if a patient falls asleep during battery-powered operating, the low battery alarms may not awaken the patient before battery depletion.This section also states that right ventricular dysfunction, especially when combined with elevated pulmonary vascular resistance, may limit the effectiveness of the left ventricular assist system due to reduced filling of the pump.It also lists typical treatment options.Section 7 ¿alarms and troubleshooting¿ details all system controller alarms and how to resolve them.The heartmate 3 lvas patient handbook is also currently available.Section 3 ¿powering the system¿ details how to check a battery's charge level, replacing low batteries with fully-charged batteries, and switching power sources.Two, new, fully charged li-ion batteries provide 17 hours of support.Batteries last for less time if the user is active or emotionally stressed.Section 5 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.This document instructs the user that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.In the event of a low battery power alarm, the user is instructed to connect to a working power source right away, and to contact your hospital contact if connecting to power does not resolve it.This section also includes detailed instructions on connecting and disconnecting to power under ¿guideline for power cable connectors.¿ 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: 11109113
• MDR Text Key: 224809078
• Report Number: 2916596-2020-06400
• 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,Followup
• Report Date: 04/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2019
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6217490
• 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
• Treatment: HEARTMATE 3 SYSTEM CONTROLLER.; HEARTMATE 3 SYSTEM CONTROLLER
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 74 YR
• Patient Weight: 74