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

Model Number 106524US

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2021

Event Type  malfunction  

Event Description

It was reported that the patient's pump was malposition.The cause of the pump malposition was not identified.Review of the log file captured persistent pi (pulsatility index) events on (b)(6) 2021.Pi events occur when there are sudden and substantial changes in the pulsatility index, these events were considered routine.All pi events will cause the hm3 vad speed to drop to its low speed limit, which was set at 4700 rpm.The periodic log also captured low flow with high pi readings on (b)(6) 2020, (b)(6) 2020, (b)(6) 2020, (b)(6) 2020, and (b)(6) 2021.The estimated flow appeared to be fluctuating below the alarm threshold of the 2.5 lpm.These occur at times when pi is elevated.These seemed to be physiological in nature.The patient was stable and listed for transplant.The cause of the low flow alarms was thought to be due to the pump position and the low flow alarms resolved with fluid.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported pump malposition could not be confirmed through this evaluation.It was reported by the center that the patient was experiencing low flow alarms due to pump malposition.The submitted log files contained multiple low flow alarms when the estimated flow decreased below a threshold of 2.5 lpm for 10 seconds or more.The pump speed remained within the set speed parameters for the duration of the log file, and the system appeared to function as intended.The patient remains ongoing on heartmate 3 left ventricle assist device (lvad), serial number (b)(6), and no further related events have been reported at this time.The heartmate 3 instructions for use (ifu) explains how to insert the pump in the ventricle and instructs the user to take care to avoid orienting the inlet towards the interventricular septum.Pump function will be compromised in the presence of inlet obstruction.This document also outlines the steps to reorient the pump.In addition, this ifu explains that the low flow hazard alarm is triggered when pump flow is less than 2.5 lpm, the pump has stopped, the pump is not operating properly, or the driveline is disconnected from the system controller.Changes in patient conditions can result in low flow, such as hypertension.This ifu and the heartmate 3 lvas patient handbook explain all system alarms and the recommended actions associated with them.Of note, low flow software decreases the low flow alarm threshold to 2.0 lpm.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The implant kit was shipped on (b)(6) 2019.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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11282862
• MDR Text Key: 247272403
• Report Number: 2916596-2021-00131
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/04/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7244536
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/07/2021
• Initial Date FDA Received: 02/04/2021
• Supplement Dates Manufacturer Received: 02/17/2021
• Supplement Dates FDA Received: 02/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 69