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

Model Number 106524US

Device Problems Malposition of Device (2616); Infusion or Flow Problem (2964)

Patient Problems Death (1802); Ventricular Tachycardia (2132)

Event Date 03/10/2020

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

It was reported that the patient was experiencing frequent low flow alarms and pi events.Low flow software was installed on the patient's controllers.The patient was hypertensive with mean arterial pressure between 130-150 mmhg.The patient's blood pressure and diuretic medication was changed.The patient was admitted with believed arrhythmia ventricular tachycardia.The patient was experiencing intermittent significant dizziness and was treated with amiodarone.The low flow alarms and arrhythmia were reported to be due to the patient's slight cannula malposition.The low flow alarms diminished slightly after the software update but did not resolve.The patient is listed for transplant.

Event Description

It was reported that the patient underwent a heart transplant; however, the patient expired shortly after transplant on (b)(6) 2020 due to surgical complications/profound coagulopathy/pulmonary edema.The explant of the pump was not due to a device or therapy related issue.The explant of the pump was not associated with a recovery of cardiac function.The device operated as expected.The death was not considered to be device related.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: low flow alarms were confirmed through the analysis of the submitted log files and the account attributes the low flow alarms, as well as the reported cardiac arrhythmia, to a known cannula malposition (originally addressed under (b)(4)).The reported malposition could not be confirmed through this evaluation as no images showing the issue were provided.Additionally, a correlation between the device and the reported patient outcome could not be conclusively determined.The submitted controller event log files contained data from (b)(6) 2020 and (b)(6) 2020.The log files captured 44 low flow controller fault flags, when calculated flow dropped as low as 1.2 lpm, below the low flow threshold of 2.5 lpm.Of these faults, 10 lasted for at least 10 seconds to trigger low flow hazard alarms.No other atypical alarms or events were captured.The actual speed remained at or above the low speed limit for the duration of the log files and the device appeared to be functioning as intended.The account communicated that the patient was having frequent low flow alarms.The patient¿s blood pressure and diuretic medications were changed.The patient was also admitted for vt for which he was treated with an antiarrhythmic.The patient has known inflow cannula malposition which the account believes to be the cause of the low flow alarms and reported arrhythmia.The alarms reportedly improved with blood pressure and volume management but were still frequent.The patient¿s controllers were upgraded to software version 1.5.2 for low flow on (b)(6) 2020.Following the upgrade, the alarms diminished but did not completely resolve.The patient underwent a heart transplant; however, the patient expired shortly after transplant on (b)(6) 2020 due to surgical complications/profound coagulopathy/pulmonary edema.Heartmate 3 lvas, serial number (b)(6), will not be returned for investigation.The device was reportedly functioning as expected.The heartmate 3 lvas 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 as pump function will be compromised in the presence of inlet obstruction.The steps to adjust the orientation of the pump are also outlined in this document.This ifu also explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling and outlines all pump parameters.This document additionally outlines all system controller alarms, including low flow alarms, as well as the appropriate actions associated with them.Per design, when the estimated flow value is calculated at less than 2.5 lpm, a low flow status is posted to the log file.If the flow remains below 2.5 lpm for 10 seconds, a low flow hazard alarm is triggered.The heartmate 3 patient handbook states that in the event of a low flow hazard alarm, call the hospital contact immediately for diagnosis and instructions.The current heartmate 3 lvas ifu (document #: (b)(4), rev.B) lists death as an adverse event that may be associated with the heartmate 3 left ventricular assist system in section 1, ¿introduction¿.The ifu also contains a section on ¿pump performance monitoring¿ under patient care and management which explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.Section 4.4 ¿clinical screen¿, contains sections on pump flow, pump speed, pulsatility index, and pump power.Per design, when the estimated flow value is calculated at less than 2.5 lpm, a low flow status is posted to the log file.If the flow remains below 2.5 lpm for 10 seconds, a low flow hazard alarm is triggered.Section 5 "surgical procedures" 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 as pump function will be compromised in the presence of inlet obstruction.The steps to adjust the orientation of the pump are also outlined in this section.The heartmate 3 patient handbook (document #: (b)(4), rev.B) contains a section on ¿alarms and troubleshooting¿ which provides information on all system alarms and the actions associated to resolve the alarms.A section on ¿handling emergencies¿ is also provided.The hm3 ifu notes that pi events are assumed by the system during cases when there are sudden and substantial changes in the pulsatility index.These events are also referred to as pi events and may be initiated for reasons other than true pi events.Some reasons include sudden changes in a patient¿s volume status, arrhythmias, sudden changes in power, and sudden changes in pump speed.Pi events are examples of routine events and do not appear in the alarm history.Pulsatility index (pi) is a calculation related to the amount of assistance provided by the pump.Pi values typically range from 1 to 10.Higher values indicate more ventricular filling and higher pulsatility (i.E., the pump is providing less support to the left ventricle).Lower values indicate less ventricular filling and lower pulsatility (i.E., the pump is providing greater support and further unloading the ventricle).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 95488
• MDR Report Key: 9949578
• MDR Text Key: 187406540
• Report Number: 2916596-2020-02073
• 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,Followup
• Report Date: 06/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6838333
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 78