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

Model Number 106524US

Device Problems Pumping Stopped (1503); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); Complete Loss of Power (4015)

Patient Problems Neurological Deficit/Dysfunction (1982); Blood Loss (2597)

Event Date 11/05/2020

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

It was reported that the patient reported to the hospital with increased left-sided weakness in arm and leg and left sided facial droop.A pump off alarm was noted after interrogating the patient's controller.The patient reported that he slept on batteries and did not hear alarm.Technical services (ts) reviewed the log file and reported that there appeared to have been a complete depletion of all external power causing a pump off event on (b)(6) 2020 at 6:44am.It was approximated that the patient was off of support between 6:44am-9:31am on (b)(6) 2020.Once the controller was powered back on with batteries the pump ramped back up to its set speed.The controller clock did reset to a default time of 1/1/2000 00:00:00.Approximately 25 hours later the clock was synced.The pump parameters appeared normal during these events.It was additionally reported that the patient additionally had a gastrointestinal (gi) bleed.The patient's plan of care includes ongoing education regarding vad care, antibiotics, esophagogastroduodenoscopy (egd), and physical therapy/occupational therapy.The patient's disposition was to be determined.It was also reported that the patient was stable, their neurologic symptoms were slowly improving, and their gi bleed resolved.The patient underwent a colonoscopy which showed ischemic colitis.Computed tomography (ct) complete and showed no evidence of clotting in the outflow graft, left atrial thrombus, or left ventricle thrombus.The patient's mesenteric arteries were open.The patient was evaluated by general surgery who decided that there was no indication for surgical intervention.The patient continued to receive medication and was planned to be discharged to acute rehab.

Manufacturer Narrative

Manufacturer's investigation conclusion: analysis of the submitted log files confirmed the reported pump off alarms due to the depletion of the external batteries and the controller's internal backup battery.The event was reportedly due to the patient sleeping on battery power and not hearing the alarms.Additionally, a direct correlation between the reported gastrointestinal (gi) bleeding and heartmate 3 left ventricular assist system (lvas), serial number (b)(6), could not be conclusively established through this evaluation.The submitted controller event log file showed that on (b)(6) 2020, the patient was connected to external battery power when low power advisory alarms activated at 01:31:24, followed by the activation of low power hazard alarms at 04:01:28.The external 14 volt batteries then became fully depleted, resulting in no external power alarms beginning at 04:40:44.The system operated on the controller¿s internal backup battery until the pump ultimately stopped at 06:44:30.When the system controller was re-connected to fully charged batteries, the timeclock subsequently reset to the default date of (b)(6) 2000 0:00:00, indicating that there had been a total loss of power to the controller.Approximately 25 hours later, on (b)(6) 2020 at 10:31:06, the clock was synched to the correct time, indicating that the pump was off from approximately 06:44 - 09:31 on (b)(6) 2020.Review of the log file data appeared to show the pump operating as intended prior to the pump stoppage event.It was later reported that the patient also had a gi bleed that resolved.A colonoscopy showed ischemic colitis.Following a computed tomography (ct), it was decided that there was no indication for surgical intervention.The patient was reportedly stable with their neurological symptoms slowly improving.The patient is currently maintained on wall power and will be discharged to acute rehabilitation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).The relevant sections of the device history records for mlp-021186 were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas instructions for use (ifu) lists bleeding and other neurological event (not stroke-related) as adverse events that may be associated with the use of the heartmate 3 lvas.Neurological dysfunction is also listed as a potential late postimplant complication that may be associated with the use of the heartmate 3 left ventricular assist system.In addition, the ifu and patient handbook explain the battery charge level, fuel gauge display, and all visual and audible alarms.Instructions for exchanging batteries and switching power sources are also provided.Both documents explain that heartmate 3 patients must be attached to the power module or mpu during sleep or any time when sleep is likely.It is also noted that depleting the batteries and the backup battery will cause the pump to stop.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 11 volt lithium-ion 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 (either the power module, mobile power unit, or two heartmate 14 volt lithium-ion batteries) 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.4 green bars = 75¿100% of battery power remains.3 green bars = 50¿75% of battery power remains.2 green bars = 25¿50% of battery power remains.1 green bar = less than 25% of battery power remains.Section 3 ¿powering the system¿ and section 6 ¿patient care and management¿ warn that the patient must always connect to the power module or 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 6 includes a section on ¿preparing for sleep¿, 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.Also, section 7 ¿alarms and troubleshooting¿ details all system controller alarms and how to resolve them.Section 6 ¿patient care and management¿ (under "anticoagulation") also outlines the recommended anticoagulation regimen (including inr range) for patients using the heartmate 3 lvas as well as the suggested anticoagulation modifications if there is a risk of bleeding.The heartmate 3 lvas patient handbook is also currently available.Section 5 ¿alarms and troubleshooting¿ provides information regarding system controller alarms and the proper actions associated with them.This section also includes detailed instructions on connecting and disconnecting to power under ¿guideline for power cable connectors.¿ 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.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: 10905574
• MDR Text Key: 218683237
• Report Number: 2916596-2020-05627
• 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: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/22/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7425374
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 57