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

Model Number 106524US

Device Problems Failure to Align (2522); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); High Blood Pressure/ Hypertension (1908); Pleural Effusion (2010); Ventricular Fibrillation (2130); Hernia (2240)

Event Date 11/24/2021

Event Type  Injury  

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 many episodes of sustained ventricular fibrillation during hm3 implant on (b)(6) 2021 and received 10 electrical shocks via pads on their chest.Amiodarone drip was started.Mean arterial pressure (map) remained stable and rhythm stabilized before leaving the operating room (or).The patient had 1 low flow alarm related to rebound hypertension after one bolus of epinephrine for hypotension.On (b)(6) 2021 the patient was noted to have some lung herniating through left thoracotomy incision on computed tomography (ct) performed for characterizing left effusion.An additional surgery was performed on (b)(6) 2021 for left lung hernia repair via thoracotomy and left pleural effusion drainage.The surgery also included lvad repositioning.The patient had left apical effusion requiring drainage placement by interventional radiologist (ir).The pump speed was briefly lowered but was returned to 560 rpm0 for better flow.The patient needs pacemaker generator change prior to discharge.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate (hm) 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events could not conclusively be established through this evaluation.In addition, the reported low flow alarm could not be confirmed as no log files were submitted for review.According to the account, the low flow alarm was related to hypertension.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6), and no further related events have been reported at this time.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 ¿introduction¿ of this document lists cardiac arrhythmia, hypertension, and bleeding as adverse events that may be associated with the use of the heartmate 3 lvas.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.Section 6 ¿patient care and management¿ states that post-implantation hypertension may be treated at the discretion of the attending physician, and any therapy that consistently maintains mean arterial blood pressure less than 90 millimeters of mercury (mmhg) should be considered adequate.Section 7 ¿alarms and troubleshooting¿ describes all alarm conditions, including the low flow hazard, as well as the appropriate actions associated with them.Section 6 ¿patient care and management¿ (under "anticoagulation") outlines the recommended anticoagulation regimen (including inr range) for patients using the heartmate 3 lvas as well as the suggested anticoagulation modifications in the event that there is a risk of bleeding.Additionally, section 6 lists arrhythmia as a potential late postimplant complication that may be associated with the use of heartmate 3 lvas.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.

Manufacturer Narrative

Additional information to the manufacturer's investigation conclusion: according to the account, the low flow alarms were related to rebound hypertension and inflow cannula misalignment.The reported inflow cannula misalignment could not be confirmed as no images were submitted for evaluation.Section 5 of the ifu 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.No further information was provided.The manufacturer is closing the file on this event.

Event Description

On (b)(6) 2021 it was reported that the 600 ml of serosanguinous effusion was noted.A 24 french left pleural blake drain was placed.On (b)(6) 2021 during the operation some low flow alarms were noted.These were initially treated with volume but the alarms persisted and the surgeon was concerned of a positioning issue of the lvad.The doctor inserted a transesophageal echocardiogram (tee) probe and the position of the inflow cannula appeared to be much more toward the septum.An intraoperative chest x-ray was obtained which also suggested that the lvad position had changed.The incision was reopened where there was some dehiscence of the gore-tex pericardial patch which likely resulted in the vad rotating somewhat.The surgeon did not believe the patch to be easy to reattach and therefore took it down and opened the pericardium further laterally to allow the device to rotate more into the left chest.This seemed to improve the position and resolve the low flow alarms.Towards the end of the case while closing the skin incisions the patient developed ventricular fibrillation for which he required multiple defibrillator shocks.The icd did not appear to fire and electrophysiology was called to interrogate the device.While doing so, the patient experienced additional bouts of vf, amiodarone was administered and electrolyte abnormalities were corrected.This seemed to improve the patient's condition and he remained electrically stable for the remainder of the case.

• 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: 13192320
• MDR Text Key: 286751889
• Report Number: 2916596-2021-07518
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8173808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• 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: 44 YR
• Patient Sex: Male
• Patient Weight: 141 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American