MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

Model Number 106524US

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371); Pumping Stopped (1503)

Patient Problems Cardiac Arrest (1762); Right Ventricular Hypertrophy (2056)

Event Date 01/19/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device: 11 days.The patient remains ongoing with the device.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2019.It was reported that the patient suffered a neurological event that led to confusion (while using the rest room) and the patient disconnected their driveline on (b)(6) 2019.The patient could not reconnect the driveline and coded.The patient underwent compressions and advance cardiopulmonary life support (acls) measures to be resuscitated.A cardiovascular fellow reconnected the patient's driveline.The account cited multiple neurological events prior and post implant that they believe led to the patient's confusion and eventual disconnection.The patient did not remember the entire day of (b)(6) 2019.Per the account, computed tomography (ct) was performed on the head, chest, and abdomen.The results of the ct scans were negative for ischemia or trauma/dislocation to pump.The account stated the cause of the neurological events had not been identified.Per the account, the patient is stable, however, right ventricular (rv) function decreased post code, and the patient was re-started on dobutamine.

Manufacturer Narrative

Manufacturer investigation conclusion: review of the submitted controller periodic log file confirmed the reported pump stoppage due to a disconnection of the driveline.However, a direct correlation between the device and the reported right heart dysfunction and neurological events could not be determined through this evaluation.The controller periodic log file contained approximately 11 days of data from 12jan2019 6:14 pm ¿ 23jan2019 9:14 am and captured data at 1-hour intervals.A lvad off event associated with driveline disconnect and low flow alarms was captured on (b)(6) 2019 at 5:14 pm.It should be noted that the account stated the driveline was disconnected at approximately 5:08 pm and the pump was stopped for over 10 minutes prior to reconnection of the driveline.Prior to and following the driveline disconnect/lvad off event, no alarms or controller fault flags were active and the pump appeared to be operating normally with stable parameters.The controller event log file revealed that the driveline disconnect event on (b)(6) 2019 had been overwritten by newer data and showed the pump operating normally with stable parameters from 20jan2019 - 23jan2019.No further information was provided.The patient remains ongoing with the device.The manufacturer is closing the file on this event.The heartmate 3 lvas ifu lists neurological event (not stroke-related) and right heart failure as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Both the heartmate 3 lvas ifu and patient handbook outline all system controller alarms as well as the appropriate actions associated with them.These documents warn that disconnecting the driveline from the system controller will result in a loss of pump function and instruct the user to promptly reconnect the driveline to resume pump operation if it disconnects from the system controller.The ifu explains that during the patient selection, preimplant, and postoperative period, the patient must receive instructions regarding the operation and care of every system component (including the driveline and what to do in an emergency) and states that both the patient and primary caregiver must be able to repeatedly demonstrate ability to successfully complete connection of a driveline to the pocket controller in a timely manner.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 8313375
• MDR Text Key: 135347879
• Report Number: 2916596-2019-00528
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/26/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6693729
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 99