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

Model Number 106524US

Device Problems Failure to Align (2522); Malposition of Device (2616); Infusion or Flow Problem (2964)

Patient Problems Dehydration (1807); Dizziness (2194)

Event Date 03/31/2022

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 computed tomography angiography (cta) images showed possible inflow cannula malposition that was to be medically managed.Patient was dehydrated and reported occasional dizziness.Fluids were given and the patient was started on florinef.The patient was discharged home with close follow up and had not reported alarms since discharge.

Manufacturer Narrative

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.The account submitted log files for review.The system controller event log file contains data from 31mar2022 at 1:22:38 through 7:45:57.Low flow events were captured throughout the log file from 31mar2022 at 2:38:50 through 6:08:22.When the flow value is calculated at less than the low flow software version 1.5.2 threshold of 2.0lpm, 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.None of the events lasted over 10 seconds, and no low flow alarms were flagged.Transient pi events were observed throughout the log file, resulting in momentary decreases in speed per design.The pump appeared to function as intended.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).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 04apr2021.The heartmate 3 lvas ifu is currently available.Section 5 entitled ¿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.Pump function will be compromised in the presence of inlet obstruction.This section also outlines the steps to reorient the pump.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.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: 14186754
• MDR Text Key: 289869825
• Report Number: 2916596-2022-10217
• 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: 06/14/2022

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: 11/19/2022
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 7842618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/05/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 06/08/2022
• Supplement Dates FDA Received: 06/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 96 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White