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

Model Number 106524US

Device Problems Decreased Pump Speed (1500); Insufficient Flow or Under Infusion (2182); Malposition of Device (2616); Infusion or Flow Problem (2964)

Patient Problems Arrhythmia (1721); No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/06/2020

Event Type  Injury  

Manufacturer Narrative

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 patient began having low flow alarms correlating with bigeminy.The patient was implanted with an icd, since then they have had multiple low flow alarms.The patient's pi is now consistently in the 10-11 range on a speed of 5200.An echo, ct chest and cxr were done.The echo showed no significant abnormalities and the ct results have not been reported yet.The patient was previously on an rvad and was given milrinone and give a dose of albumin.The log file captured low speed advisory alarms on 11/6 due to set speed changes to 4500 rpm (low speed 4800rpm) & 5000rpm (low speed at 5300rpm).No further information was provided.

Event Description

It was reported that the patient had multiple low flow alarms and and low speed advisories.It was determined that the cause of the low flow alarms was pump malposition and they were resolved with speed optimization.The device operated as expected and the patient was dizzy but that resolved.On a repeat tte, the inflow cannulas were seen to be directed towards the septum.A ct showed slight eccentric positioning of inflow cannula of the heartmate 3 lvad did not appear to be hemodynamically significant.There was no inflow or outflow cannula thrombus.The surgeon said that further surgical intervention would not benefit the patient.Patient was optimized with rpm and diuretics and discharged on (b)(6) 2020.

Event Description

It was reported that the patient had multiple low flow alarms and low speed advisories.It was determined that the cause of the low flow alarms was pump malposition and they were resolved with speed optimization.The device operated as expected and the patient was dizzy but that resolved.On a repeat tte, the inflow cannulas were seen to be directed towards the septum.A ct showed slight eccentric positioning of inflow cannula of the heartmate 3 lvad did not appear to be hemodynamically significant.There was no inflow or outflow cannula thrombus.The surgeon said that further surgical intervention would not benefit the patient.Patient was optimized with rpm and diuretics and discharged on (b)(6) 2020.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the device and the reported inflow conduit misalignment could not conclusively be established through this investigation.The evaluation of the submitted log files confirmed the reported low flow alarms.The controller event log file contained data from (b)(6) 2020 14:31:28 transient low flow fault flags were captured throughout the duration of the file, resulting in a total of 31 low flow hazard alarms on (b)(6) 2020.Most of the observed low flow events also appeared to be associated with elevated pi values ranging from 11.6-14.1.No other atypical events were captured.Despite these alarms, the pump appeared to function as intended and operated at the set speed for the duration of the file.The lvad event log file captured low flow events.The controller and lvad periodic log files appeared to capture the pump operating as intended.The account reported low flow alarms correlating with bigeminy and dizziness.The patient was also implanted with an implantable cardioverter defibrillator (icd).The account did an echo, which showed no significant abnormalities (no ai).The cause of the low flow alarms was determined to be inflow conduit misalignment.On repeat transthoracic echocardiogram (tte), the inflow cannula was seen to be directed towards the septum.There was no inflow or outflow cannula thrombus.Further surgical intervention would not likely benefit the patient.He was then optimized with rpm and diuretic which resolved the alarms and was discharged (b)(6) 2020.The device operated as expected.No product available for investigation.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.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 04sep2020.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: 10895336
• MDR Text Key: 217983289
• Report Number: 2916596-2020-05817
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/06/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7485228
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/06/2020
• Initial Date FDA Received: 11/24/2020
• Supplement Dates Manufacturer Received: 03/02/2021; 03/23/2021
• Supplement Dates FDA Received: 03/19/2021; 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention