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

Model Number 106524US

Device Problems Pumping Stopped (1503); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Encephalopathy (1833); Hypoxia (1918); Brain Injury (2219); Syncope/Fainting (4411)

Event Date 03/27/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

Related manufacturer report number: 2916596-2022-02021.It was reported that the patient had backup battery fault alarms on (b)(6) 2022.The patient called their friend to assist with controller exchange but when the friend arrived, the patient lost consciousness.The controller was exchanged and the new controller was connected.Flow rates were 3.8.Upon interrogation of the device it was discovered that the ventricular assist device (vad) was off for 20 minutes but it was unclear as to what happened since the initial alarm was an advisory alarm.A review of the log files revealed battery backup fault alarms which began on (b)(6) 2022 at 1342 and continued to 1434 when the driveline was disconnected.A battery was connected back up and the pump started running again until the driveline was disconnected again at 1450.The event log file of the new controller was only 5 lines of data recorded.There were no unusual events seen within this log file.

Manufacturer Narrative

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

Event Description

Related manufacturer report number: 2916596-2022-02021.Additional information revealed that the patient passed away on (b)(6) 2022 due to an anoxic brain injury.After the patient lost consciousness during the controller exchange, they had respiratory distress with hypoxia requiring intubation.Later findings revealed acute encephalopathy with no signs of neurologic recovery.The family proceeded with palliative care.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported events could not be conclusively established through this evaluation.The account submitted log files for review.The system controller event log file contains data from (b)(6) 2022 at 21:07:41 through 18:22:23 and (b)(6) 2022 at 14:42:50 through 17:15:39.The driveline was disconnected on (b)(6) 2022 at 14:35:24 and reconnected at 14:48:29, again disconnected at 14:50:29 during a controller exchange.The controller was shut off on (b)(6) 2022 at 15:03:48.Prior to the driveline being disconnected, multiple backup battery faults were captured.Transient pi events were observed throughout the log file, resulting in momentary decreases in speed per design.The pump appeared to function as intended.The heartmate 3 lvad, serial number (b)(6), was not returned for evaluation.The heartmate 3 lvas ifu, rev.C, is currently available.This ifu death as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.In section 2 "system operations" (under "system controller warnings and cautions"), the ifu states, "if the driveline disconnects from the system controller, the pump stops.If the driveline disconnects from the system controller, promptly reconnect it to resume pump operation." section 2 also contains a section titled "connecting the driveline to the system controller", which provides instructions on connecting/disconnecting the driveline to/from the system controller and making sure that it is fully and properly inserted into the system controller socket.Section 7 "alarms and troubleshooting" outlines all system controller alarms, including the driveline disconnected hazard alarm, as well as how to respond to each alarm condition.Section 6 (under "educating and training patients, families, and caregivers") 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).The heartmate 3 lvas patient handbook, rev.C, warns "the pump will stop if the driveline is disconnected from the system controller.If the driveline disconnects from the system controller, reconnect it right away to restart the pump.The pump cannot run without power." in addition, the patient handbook states, "call your hospital contact if you think that, for any reason, any portion of your equipment is not functioning as usual, is broken, or you are uncomfortable with the operation of the equipment." the patient handbook also contains a section on handling emergencies.Section 5 ¿alarms and troubleshooting¿ contains information regarding all system controller alarms, including the driveline disconnected hazard alarm, and the proper actions associated with the relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The relevant sections of the device history records for the percutaneous lead were also reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2018.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: 14102659
• MDR Text Key: 289183690
• Report Number: 2916596-2022-02020
• 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,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6502680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2018
• 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; Life Threatening; Death
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 66 KG