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

Model Number 106524US

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tachycardia (2095); Ventricular Fibrillation (2130)

Event Date 07/01/2022

Event Type  Injury  

Event Description

It was reported that the patient did their own controller exchange without consult.The patient was admitted for ventricular fibrillation/icd (implantable cardioverter defibrillator) implant.The log file captured low flow events on (b)(6) 2022 that occurred when pi (pulsatility index) was elevated.During the low flow events there was a driveline disconnect at 4:33 pm on (b)(6) 2022.The pump appeared to have been off for 33 seconds before being reconnected.The backup controller appeared to have been connected for about 10 seconds.Related manufacturer report number of controller: 2916596-2022-12323.

Manufacturer Narrative

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

Manufacturer Narrative

The patient had a previous admission for arrhythmia (mfr# 2916596-2022-11087).Manufacturer's investigation conclusion: the analysis of the log files provided by the account confirmed the reported low flow events.According to the account, the low flows were caused by the patient¿s arrhythmia.A direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported arrhythmia could not conclusively be established through this evaluation.The submitted system controller event log file contained data on (b)(6) 2022 from 16:29:23 through 16:33:12, when the driveline was disconnected.It appeared that the patient connected to their backup controller for approximately 9 seconds before reconnecting back onto the patient¿s primary controller.Data continued to be captured from (b)(6) 2022 at 16:33:53 through (b)(6) 2022 at 10:09:11.The file captured low flow events prior to the initial driveline disconnection.Following the reconnection to the primary controller, eight additional low flow events were captured.The pump appeared to operate as intended at the set speed while the driveline was connected to the system.The patient remains ongoing on heartmate 3 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 implant kit was shipped on 01jun2021.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of this document lists cardiac arrhythmia as an adverse event that may be associated with the use of heartmate 3 left ventricular assist system.Section 1 also provides an explanation of all pump parameters, including flow.Section 4 provides information for the system monitor describing the pump flow display and the hazard alarms.This ifu states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 liters per minute (lpm).The ifu explains that changes in patient conditions can result in low flow.Section 6 entitled ¿patient care and management¿ lists arrhythmia as a potential late postimplant complication.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.Heartmate 3 lvas patient handbook is also currently available.Section 5 "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient sustained a fall and was found to be in ventricular fibrillation (vf) upon emergency medical services (ems) arrival.Upon arrival to the emergency department, the patient had multiple episodes of recurrent ventricular tachycardia (vt).The patient was cardioverted.The patient did not have a history of vf pre-left ventricular assist device (lvad) and it was unknown if the event was thought to be device related.The patient was started on anti-arrhythmic medication, had vt ablation and an automatic implantable cardioverter-defibrillator (aicd) placement.In addition, the account stated that the arrhythmia caused the low flow alarms and have resolved with arrhythmia treatment.The account added that the patient thought that changing the controller would fix the alarm.The patient was re-educated on when to perform a controller exchange (only when instructed to when speaking to coordinator via emergency pager).Lastly, the account communicated that the equipment operated as intended prior and after the controller exchange.The patient has been doing well after the ablation and aicd placement.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: 15114752
• MDR Text Key: 296713321
• Report Number: 2916596-2022-12144
• 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: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/06/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7972494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/14/2021
• 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; Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 87 KG