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

Model Number 106524US

Device Problem Infusion or Flow Problem (2964)

Patient Problems Cardiac Tamponade (2226); Thrombosis/Thrombus (4440)

Event Date 06/03/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had low flow alarms and log file review was requested to know when the alarms began.Log file analysis contained low flow estimates as well as sustained low flow hazard events on (b)(6) 2022.The low flow readings occurred between 3:31 am - 8:02 am.These flow readings do not appear to be the result of any equipment malfunction.The cause of the low flows were determined to be from cardiac tamponade and they resolved when the patient was taken to the operating room for clot removal.

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the submitted log files confirmed low flow alarms.According to the account, the low flow events were caused by cardiac tamponade.A direct correlation between (b)(6) and the reported cardiac tamponade and clots could not be conclusively determined through this investigation.The submitted controller event log file captured transient low flow hazard alarms on (b)(6) 2022.The system appeared to operate as intended at the set speed for the duration of the file.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).The relevant sections of the device history records for (b)(6) were reviewed and showed no deviation from manufacturing or quality assurance specifications.The heartmate (hm) 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of the ifu, ¿introduction¿, lists pericardial fluid collection and peripheral thromboembolic event as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 1 also provides an explanation of all pump parameters, including flow.This section explains that pump flow is a calculated value that is estimated based on pump power.Section 4 ¿system monitor¿ provides information about the pump flow display and the low flow hazard alarm condition.This section states that the low flow hazard alarm will be triggered when the estimated pump flow is less than 2.5 lpm and explains that changes in patient conditions can result in low flow.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.Section 6 of the ifu, ¿patient care and management¿, lists thromboembolisms as a potential late post-implant complication.This section, under ¿anticoagulation¿, provides information regarding the recommended anticoagulation regimen, including inr values, as well as suggested anticoagulation modifications.Heartmate 3 lvas patient handbook is 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: 14799041
• MDR Text Key: 294666329
• Report Number: 2916596-2022-11665
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/15/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8430321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/06/2022
• Initial Date FDA Received: 06/24/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2022
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Race: White