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

Model Number 106524US

Device Problems Malposition of Device (2616); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Syncope/Fainting (4411)

Event Date 06/23/2022

Event Type  Injury  

Event Description

It was reported that the patient had low flow alarms and the customer needed documentation to support a need for elevated status on transplant list due to continuous suction events.The event log did not capture any low flow events which could have been overwritten by the persistent and significant amount of pulsatility index (pi) events that occurred on (b)(6) 2022.The periodic log captured some low flow events on (b)(6) 2022, (b)(6) 2022, (b)(6) 2022, (b)(6) 2022 with high pi events and the estimated flow was fluctuating below the 2.5 liters per minute (lpm) threshold.The patient had syncopal episodes at the time of the low flows.Although they are not resolved, the low flows improved with hydration.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the patient¿s submitted log files confirmed a low flow alarm; however, a direct cause for the reported event could not be conclusively determined through this evaluation.Additionally, a direct relationship between the device and the reported syncopal events could not be conclusively determined though this investigation.The controller event log file contained data on 23jun2022 from 13:15:51 to 14:09:52.The pump operated as intended at the set speed for the duration of the log file.The log file consisted entirely of pulsatility index (pi) events.The controller periodic log file contained data from 12jun2022 to 23jun2022.The log file recorded a low flow alarm on 18jun2022 indicating that the flow dropped below the low flow threshold for 10 seconds or longer.The log files appeared to capture the pump operating as intended.The patient remains ongoing on ventricular assist device (vad) support with no further issues reported.Review of the device history record showed no deviations from manufacturing and qa (quality assurance) specifications.The heartmate 3 lvas ifu is currently available.The system monitor section describes the pump flow display (4-12 through 4-14) and the hazard alarms (4-18 and 4-26).This ifu states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 liters per minute (lpm) and explains that changes in patient conditions can result in low flow, such as hypertension.The alarms and troubleshooting section describes the actions to take in the event of a low flow alarm (7-7 and 7-11).Section 6 "patient care and management" (under "ongoing patient assessment and care") includes a list of heartmate 3 patient assessment methods, including assessment of the patient's level of consciousness.Section 1 "introduction" explains that ventricular blood may flow either through the lvad or the aortic valve to reach the aorta, the proportion of which depends greatly upon the degree of the patient's cardiac function and the set speed of the lvad.Section 4-24 of the ifu states 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.Section 4 also notes that the selected speed may be adjusted based on clinical judgment regarding the need for periodic aortic valve opening and a palpable pulse.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient had a bariatric surgery to lose weight to get to transplant which triggered the low flows and high pi values that were previously reported.This was consistent with the malposition of the device.The transplant listing was advanced and the patient remained in the hospital until transplant.The patient was reportedly alive and on extracorporeal membrane oxygenation (ecmo) post transplant in a different facility.No device was to be returned for evaluation.

Manufacturer Narrative

Manufacturer's investigation conclusion: evaluation of the patient¿s submitted log files confirmed a low flow alarm, and the account attributed the alarms to the patient¿s pump malpositioning; however, the report of pump malpositioning could not be confirmed through this evaluation as no images were submitted for review.Additionally, a direct relationship between the device and the reported syncopal events could not be conclusively determined though this investigation.The pump was not returned for evaluation.Review of the device history records showed no deviations from manufacturing and qa (quality assurance) specifications.The heartmate 3 left ventricular assist system instructions for use, is currently available.Section 1 ¿introduction¿ of this ifu 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.Additionally, this section (under ¿optimal fixed speed¿) outlines how to determine the optimal fixed speed and low speed limit.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.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.Section 6 "patient care and management" (under "ongoing patient assessment and care") includes a list of heartmate 3 patient assessment methods, including assessment of the patient's level of consciousness.Section 1 "introduction" explains that ventricular blood may flow either through the lvad or the aortic valve to reach the aorta, the proportion of which depends greatly upon the degree of the patient's cardiac function and the set speed of the lvad.Section 4-24 of the ifu states 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.Section 4 also notes that the selected speed may be adjusted based on clinical judgment regarding the need for periodic aortic valve opening and a palpable pulse.The 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: 15003653
• MDR Text Key: 295811602
• Report Number: 2916596-2022-12065
• 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,Followup
• Report Date: 09/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/15/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6592691
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2018
• 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): Required Intervention; Hospitalization
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 130 KG