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

Model Number 106524US

Device Problem Infusion or Flow Problem (2964)

Patient Problem Right Ventricular Dysfunction (2054)

Event Date 05/12/2020

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 the patient was experiencing frequent low flows at home.Patient remains on anticoagulation therapy, and coumadin has been held due to supratherapeutic inr.The physician on site did a review the echocardiogram images, left ventricular size is small.Their right ventricle is severely dilated causing moderate to severe dysfunction.Ivc is increased to 3 cm.The site will decrease the lvad speed to 4800 rpms and also suggested that she take bumetanide 0.5 mg on a daily basis.Lisinopril has also been increased to 5 mg twice daily from 2.5 and 5 mg.

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between heartmate 3 lvas, serial number (b)(6), and the reported right heart failure and hypertension could not be conclusively established through this evaluation.Review of the submitted log files confirmed multiple low flow events; however, a specific cause could not conclusively be determined through this evaluation.It was reported that the patient presented after frequent low flow alarms at home.The pump speed was reduced to 4800 rpm from 4900 rpm.An echocardiogram showed right heart enlargement.Medications were adjusted.It was reported that the low flows decreased after controlling mean arterial pressure.It was unknown if a device related issue contributed to the right heart failure.The patient was treated with increased antihypertensives.The plan of care is to continue with the prescribed hypertensives and diuretics.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6) and no further related events have been reported at this time.The hm3 lvas ifu lists right heart failure and hypertension as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.The hm3 lvas ifu explains that the low flow hazard alarm will be triggered when pump flow is less than 2.5 lpm and notes that changes in patient conditions can result in low flow.This ifu also describes all system alarms and the recommended actions associated with them.It also addresses suction events and states pi events are assumed by the system during cases when there are sudden and substantial changes in the pulsatility index.These events are also referred to as pi events and may be initiated for reasons other than true pi events.Some reasons include sudden changes in a patient¿s volume status, arrhythmias, sudden changes in power, and sudden changes in pump speed.The most recent revision of the heartmate 3 lvas ifu of this document lists right heart failure and hypertension as adverse events that may be associated with the use of the heartmate 3 left ventricular assist system, as well as all other adverse events.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.¿ the system monitor section describes the pump flow display (4-12 through 4-14) and the hazard alarms (4-18 and 4-26).This ifu states that the low flow hazard alarm will be triggered when pump flow is less than 2.5 lpm and explains that changes in patient conditions can result in low flow.The alarms and troubleshooting section describes the actions to take in the event of a low flow alarm (7-7 and 7-11).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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10123415
• MDR Text Key: 194148968
• Report Number: 2916596-2020-02751
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

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: Health Professional
• Device Expiration Date: 03/20/2021
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6813585
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 06/05/2020
• Supplement Dates Manufacturer Received: 08/20/2020
• Supplement Dates FDA Received: 08/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 48