MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSIST) BYPASS

Model Number 106524

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2022

Event Type  malfunction  

Manufacturer Narrative

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 long history of low flow alarms which was thought to be related to both inflow cannula positioning causing dynamic occlusions and dehydration.A previously reported outflow graft occlusion was noted on prior imaging that appeared to have improved on repeat imaging.The site was concerned that the patient's flows were between 3.2 and 3.8.The patient's blood pressure was within range and did not appear overtly dehydrated.Log files captured two low flow events where the calculated flow appeared to have fluctuated below the alarm threshold and therefore was not sustained for long enough to activate the audible alarm.

Event Description

The account requested a software upgrade on the patient¿s controllers with a low flow hazard alarm threshold set to 2.0lpm.According to the account, the updated software was successful on both primary and backup controllers.

Manufacturer Narrative

The patient's previous imaging showing an outflow graft occlusion was reported under manufacturer report number 2916596-2022-00646.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 16jun2022 at 10:33:27 through 11:35:59.Low flow events were captured throughout the log file from 16jun2022 at 11:26:03 and 11:26:25.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.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.Multiple attempts for additional information were sent to the customer and no further detail was provided.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 30mar2017.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 surgical procedures section of the hm3 ifu contains information on preparing the sealed outflow graft and explains how to attach the sealed outflow graft to the aorta.The attaching the sealed outflow graft to the pump subsection instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.The de-airing the pump subsection explains that when the pump is in place and the sealed outflow graft anastomoses is completed, residual air must be completely evacuated from the device blood chamber prior to initiating device activation.When de-airing is completed, slide the bend relief over the metal fitting of the sealed outflow graft toward the locking screw ring until it engages into place.This section warns that failure to connect the bend relief so that it is fully and evenly connected can allow kinking and abrasion of the graft, which may lead to serious adverse events such as low left ventricular assist device flow and/or bleeding.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.

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• 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: 14946475
• MDR Text Key: 304181151
• Report Number: 2916596-2022-11853
• 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: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/30/2019
• Device Model Number: 106524
• Device Catalogue Number: 106524US
• Device Lot Number: 5926570
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/18/2017
• 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 Age: 66 YR
• Patient Sex: Male
• Patient Weight: 81 KG