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

Model Number 106524US

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

Patient Problems Hypoxia (1918); Pulmonary Edema (2020); Tachycardia (2095); Cardiogenic Shock (2262); Pericardial Effusion (3271); Heart Failure/Congestive Heart Failure (4446)

Event Date 05/27/2022

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 was admitted to the intensive care unit post operatively in cardiogenic shock and was hypertensive on admission with some low flow alarms.Epinephrine was weaned off and the patient was on milrinone, dobutamine, and nicardipine infusions.Hemodynamics and end organ function were monitored while weaning inotropic support.They also had post-operative acute hypoxic respiratory failure second to atelectasis and acute pulmonary edema.The patient improved quickly and was extubated on post-operative day 1 to high flow nasal cannula.The patient was then on room air.On (b)(6) 2022 the patient had urinary retention requiring placement of a foley catheter.Urology was consulted and recommended keeping in the foley for at least three days and starting flomax.The patient had right heart failure and as of (b)(6) 2022 they remained on the continuous milrinone infusions with plans to wean off once the patient was euvolemic.On (b)(6) 2022 the patient was noted to have a non-sustained ventricular tachycardia on the celemetry monitor, and electrolytes were monitored and repleted as needed.On (b)(6) 2022 an echocardiogram revealed pericardial effusion confined to the right ventricle apex and right ventricle outflow tract with no evidence of tamponade.On (b)(6) 2022 the patient was weaned off milrinone.On (b)(6) 2022 the patient was started on digoxin for right ventricle support.

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 ifu is currently available.This ifu lists hypertension, respiratory failure, right heart failure, and cardiac arrhythmia as adverse events that may be associated with the use of heartmate 3 lvas.It also 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.¿ in addition, this document outlines the recommended anticoagulation regimen and inr range.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: 14755635
• MDR Text Key: 294406220
• Report Number: 2916596-2022-11479
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2022

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/06/2024
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8383785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2022
• Initial Date FDA Received: 06/21/2022
• Supplement Dates Manufacturer Received: 08/02/2022
• Supplement Dates FDA Received: 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2022
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Race: Black Or African American