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

Model Number 106524US

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Bacterial Infection (1735); Fall (1848); Sepsis (2067); Embolism/Embolus (4438); Skin Infection (4544)

Event Date 07/04/2022

Event Type  Injury  

Manufacturer Narrative

Related mfr # 2916596-2021-06143 captures the patient's onset of infection.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the patient had a sudden drop in flows of about 0.0-1.2 liters per minute (lpm) at around midnight.500 cc of intravenous (iv) fluid bolus was given and the flows improved to a baseline of 4 lpm.It was clinically thought to be due to hypovolemia, but the patient had continuous low flows for 90 minutes with flows around 1.0-2.0 lpm.The patient remained with a stable doppler mean arterial pressure (map) and was alert and oriented at that time.Log files captured low flows between 1:03 am and 2:34 am and flows dropped as low as 0.6 lpm.There were multiple motor instability faults that occurred prior to the low flows.There were no other unusual events recorded in the log file event history and the device operated as intended.The patient also presented with a mechanical fall to their bottom and denied hitting their head or any syncope.The patient complained of abdominal pain and had a chronic driveline infection.The driveline infection was treated with multiple course of iv antibiotics.The patient's international normalized ratio (inr) was 1.4 and they were started on a heparin drip.Lactate dehydrogenase (ldh) was stable at 297 and the patient was admitted to outpatient hospice care.The patient was not a pump exchange candidate due to noncompliance, their known chronic driveline infection, and showing septic emboli to spleen.They were in hospice care and the patient was noted to be do not resuscitate (dnr).On (b)(6) 2022 the left ventricular assist device was disconnected after goals of care discussion.

Manufacturer Narrative

Previous admissions for infection: mfr numbers # 2916596-2021-04136, #2916596-2021-06143, # 2916596-2021-05086, # 2916596-2022-00007.Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported events could not be conclusively determined through this evaluation.Additionally, analysis of the log files that was provided by the account confirmed low flow events; however, a specific cause could not conclusively be determined through this evaluation.The account submitted log files for review.The system controller event log file contains data from (b)(6) 2022 at 0:57:02 through 2:34:44.Elevations in pump power and estimated flow were captured throughout the log file on (b)(6) 2022 at 0:57:02 through 1:03:52, ranging from 7.23-8.6 watts.It should be noted that transient motor instability and harmonic compensation lvad live fault flags were recorded during this timeframe.No other notable events or alarms were captured.The pump appeared to function as intended at the set speed.Low flow events were captured throughout the log file from (b)(6) 2022 at 1:03:52 through 2:34:44.Per design, when the flow value is calculated at less than 2.5 lpm, a low flow status is posted to the log file.A 10-second delay is imposed between the detection of the low flow status and the activation of the associated audio and visual indicators on the system controller.Some of the events lasted over 10 seconds, and low flow alarms were flagged.The pump appeared to function as intended.The heartmate 3 lvad, serial number (b)(6), was disconnected on (b)(6) 2022 and remained implanted in patient.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) 2021.The heartmate 3 lvas ifu is currently available.Section 1 ¿introduction¿ of this document lists infection as an adverse event that may be associated with the use of the heartmate 3 left ventricular assist system.This section also addresses all pump parameters, including pump power and flow.The section entitled ¿system monitor¿ 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.The section entitled ¿alarms and troubleshooting¿ explains all system alarms and the recommended actions associated with them.This document also explains 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.If the system detects a pi event, the pump speed automatically drops to the low speed limit and slowly ramps back up at a rate of 100 rpm per second to the fixed speed setpoint.This drop in speed is accompanied by a reduced pump flow.There are no audible alarms with a pi event.The heartmate 3 lvas patient handbook is also available.The section entitled "alarms and troubleshooting" outlines all system controller alarms as well as how to respond to each alarm condition.This document patient 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: 15088220
• MDR Text Key: 296463490
• Report Number: 2916596-2022-12101
• 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
• Report Date: 10/26/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/13/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7755438
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/04/2022
• Initial Date FDA Received: 07/22/2022
• Supplement Dates Manufacturer Received: 10/25/2022
• Supplement Dates FDA Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2020
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American