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

Model Number 106524INT

Device Problems Mechanical Problem (1384); High Readings (2459)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

Reporter name, email: (b)(6).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 account noted an elevated power consumption in the log files during a regular follow-up visit at clinic on (b)(6) 2020.The patient did not report any observations or events.A review of the log files noted a temporary elevated power on the morning of (b)(6) 2020 combined with a noticeable rotor noise and rotor displacement.The pump parameters normalized following this event.The patient was doing well before and after the event.The patient was asymptomatic.The patient was sent home following routine check-up.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of elevated power consumption and rotor noise was confirmed via the submitted log files.A root cause for the power elevations and rotor noise could not be conclusively determined through this investigation.The submitted system controller event log 10 transient measurements of elevated power were captured on (b)(6) 2020 between 09:16 and 09:18.The power then returned to typical values for the remainder of the log file.The pump operated at the set speed for the duration of the log file.The system appeared to function as intended.The submitted lvad event log file captured rot_noise flags on (b)(6) 2020 between 09:16 and 09:18; aligning with the elevated power measurements captured within the controller event log file.The noise decreased to typical values at the end of the log.9 low flow measurements below 2.5 lpm were captured.Based on complaint history and similarly reported events, the data captured in the log files is potentially consistent with a deposition or thrombus formation passing through the system; however, a specific cause for the low flow, rotor instability, and rotor noise cannot be conclusively be determined through this evaluation as the pump was not returned.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 lvas ifu and the heartmate 3 lvas patient handbook are currently available.This ifu lists thromboemolism as a "potential risk and adverse event," as well as a "potential late postimplant complication" that may be associated with the use of the heartmate 3 left ventricular assist system.The patient care and management section of the ifu outlines indications of thrombus and how to respond to such events.This section also discusses anticoagulation, including recommended inr values.Section 1 of the ifu also addresses all pump parameters, including pump flow.Section 4, ¿system monitor¿, describes the pump flow display and the hazard alarms.This ifu states that the low flow hazard alarm will be triggered when 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 alarm, as well as the appropriate actions associated with them.No further information was provided.The manufacturer is closing this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11015717
• MDR Text Key: 222065916
• Report Number: 2916596-2020-06220
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2019
• Device Model Number: 106524INT
• Device Lot Number: 5502819
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention