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

Model Number 106524US

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Loss of consciousness (2418)

Event Date 06/03/2022

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: 2916596-2022-11845.It was reported the patient was found unresponsive following a loss of electricity at home.Their family did a controller exchange so these logs were on the new (back-up) controller.Additional information revealed that the patient passed away on (b)(6) 2022.The cause of death was unknown.Whether the outcome was device or therapy related was not provided.It is unknown if the device will be returned for evaluation.

Manufacturer Narrative

Section a4: patient weight was requested but not provided.Manufacturer's investigation conclusion: a direct relationship between the device and the reported patient outcome and low flow events could not be conclusively determined through this investigation.Evaluation of the submitted log files confirmed low flow events.The backup controller event log file captured transient low flow fault flags resulting in 30 low flow hazard alarms on 03jun2022.A specific cause for these alarms could not be determined through this evaluation.No other atypical events were captured.Despite these events, the pump appeared to function as intended and operated at the set speed for the duration of the file.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The pump shipped on 08sep2021.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 ¿introduction¿ of this document lists death as an adverse event that may be associated with the use of the heartmate 3 lvas.The system monitor section of the ifu describes the pump flow display and pulsatility index and the hazard alarms.This document states that the low flow hazard alarm will be triggered when pump flow is less than 2.5lpm and explains that changes in patient conditions can result in low flow.The alarms and troubleshooting section describes the actions to take in the event of a low flow alarm.The heartmate 3 lvas patient handbook is also currently available.Section 5 of this handbook, entitled "alarms and troubleshooting," describes the actions to take in the event of a low flow alarm.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Related manufacturer report number for mobile power unit: 2916596-2022-12226.A review of the primary controller event file found power to the mobile power unit (mpu) interrupted on (b)(6) 2022 at 0002:26.There were low power hazard and power cable disconnect alarms while power to the mpu was interrupted.The emergency backup battery (ebb) began operating the system on (b)(6) 2022 at 00002:27.The ebb operated the system until (b)(6) 2022 at 0009:44 when the driveline was disconnected.There were no external power & power cable disconnect alarms while the system was operating on the ebb.The periodic log from the primary controller was unremarkable.

• 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: 14852438
• MDR Text Key: 294921140
• Report Number: 2916596-2022-11847
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8114061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/27/2021
• 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): Life Threatening; Death
• Patient Age: 69 YR
• Patient Sex: Male