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 Dehydration (1807); Ventricular Fibrillation (2130); Loss of consciousness (2418)

Event Date 05/02/2022

Event Type  Injury  

Event Description

It was reported that the patient had frequent low flow alarms so the controller was replaced with the backup controller.The log file captured low flow alarm events on (b)(6) 2022.There was a momentary low flow event on (b)(6) 2022 that did not generate an alarm.After the low flow alarms, the patient then removed all external power from the system controller, then disconnected the driveline.The low flow events seemed to be a patient hemodynamically related issue and not a vad (ventricular assist device) related issue.The low flow alarms occurred due to ventricular fibrillation.Ventricular fibrillation improved and low flow alarms improved during emergency transport.On (b)(6) 2022, the patient was readmitted due to ventricular fibrillation which reduced the pump flow and patient lost consciousness.The patient was discharged on (b)(6) 2022.

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 experienced loss of consciousness due to the ventricular fibrillation.The only treatment performed was fluid replacement.The ventricular fibrillation disappeared in a short period of time.The arrhythmia disappeared before defibrillation.The details of the arrhythmia were unknown.It was likely that the patient's dehydration was the trigger.It was considered that the arrhythmia in this event was not associated with the device.The ventricular fibrillation did not exist pre-implant of the left ventricular assist device (lvad).Implantable cardioverter-defibrillator (icd) insertion was not considered at this time because the patient recovered in a short time.

Manufacturer Narrative

Manufacturer's investigation conclusion: the analysis of the log files provided by the account confirmed the reported low flow alarms.According to the account, the low flow alarms occurred due to ventricular fibrillation (vf).A direct correlation between heartmate 3 left ventricular assist system (lvas), serial number: (b)(6), and the reported vf could not conclusively be established through this evaluation.The submitted system controller event log file contained data from 29apr2022 through 05may2022.Starting on (b)(6) 2022, the file captured low flow hazard alarms until the end of the file, when the driveline was disconnected, consistent with the report of the patient exchanging to their backup controller due to frequent low flow alarms.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 06jun2019.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 the heartmate 3 left ventricular assist system.Section 1 of the ifu provides an explanation of all pump parameters, including flow.Section 4 "system monitor" provides information about the pump flow display and the low flow hazard alarm.This section states that the low flow hazard alarm will be triggered when the estimated 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¿ also 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.The 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.This document instructs the user that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.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 (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: 14634588
• MDR Text Key: 294147986
• Report Number: 2916596-2022-11147
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/26/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7004810
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 50 KG