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

Model Number 106524US

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

Patient Problems Hemorrhage/Bleeding (1888); Renal Failure (2041); Seroma (2069); Heart Failure/Congestive Heart Failure (4446)

Event Date 07/01/2022

Event Type  Injury  

Manufacturer Narrative

Patient initials requested but not provided.Device serial number requested but not provided.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that on (b)(6) 2022 the perioperative transesophageal echocardiography revealed severe right ventricle dysfunction.The patient was admitted post-op to the intensive care unit and was placed on inotropes and vasopressors.The patient experienced intraoperative blood loss and was put on protamine.On (b)(6) 2022 the patient was taken off vasopressors and dobutamine was weaned to 2.5 mcg/kg/min.Epinephrine of 0.1 mcg/kg/min and dopamine of 5 mcg/kg/min was continued.On (b)(6) 2022 patient was weaned off dobutamine, started weaning off epinephrine, and continued inotropes.On (b)(6) 2022 dopamine and inotropes were continued and the patient was still weaning off epinephrine.On (b)(6) 2022 the patient was taken off epinephrine, dopamine, and inhaled vasodilators.The patient continued dobutamine.There was no device related issue that caused/contributed to the event.The event resolved without sequelae on (b)(6) 2022.On (b)(6) 2022 it was noted that the patient experienced increasing low flow alarms over the past 2 weeks.The patient was asymptomatic and the computerized tomography did not show any outflow tract occlusion.The patient also experienced an acute kidney injury that was likely pre-renal.On (b)(6) 2022 the patient's blood urea nitrogen (bun)/creatinine ratio (cr) was 25/1.And on (b)(6) 2022 the patient's bun/cr ratio was 28/1.4.On (b)(6) 2022 the patient still experienced occasional low flow alarms and as of (b)(6) 2022 the patient remained asymptomatic.

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 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 (b)(6) 2022 the heartmate 3 lvas instructions for use (ifu) is currently available.This ifu lists right heart failure, bleeding, and renal dysfunction as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.The ifu states ¿right heart failure can occur following implantation of the pump.Right ventricular dysfunction, especially when combined with elevated pulmonary vascular resistance, may limit the effectiveness of the left ventricular assist system due to reduced filling of the pump.¿ section 6 also cautions the user that right heart failure can occur following implantation of the pump and outlines the associated treatment options.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.

Event Description

It was reported that on (b)(6) 2022 a palapable knot was found at previous right axillary impella site.There were no signs of infection, white blood cell count was 10.4.The patient experienced a dizziness episode with standing due to the swelling in right axillary area.Entresto was placed on hold since it was a new medication.Cardiothoracic evaluation was done on (b)(6) 2022 and found that there was no intervention needed.The condition was likely due to seroma, and the patient was discharged home.

• 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: 15136527
• MDR Text Key: 296944112
• Report Number: 2916596-2022-12150
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 813024013297
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/18/2024
• Device Model Number: 106524US
• Device Lot Number: 8498130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 62 KG