MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

Model Number 106524

Device Problems Kinked (1339); Infusion or Flow Problem (2964)

Patient Problem Heart Failure (2206)

Event Date 04/21/2018

Event Type  Injury  

Manufacturer Narrative

The known kink in the outflow graft is originally reported under mfr# 2916596-2018-00898.The heartmate 3 lvas was implanted during the momentum 3 clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The same device is used commercially and in the ongoing momentum 3 trial.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).Approximate age of device - 5 years, 6 months.The patient remains ongoing with the device.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2017.It was reported the patient was admitted with low flow alarms.A right-sided heart catheterization (rhc) was performed while on milrinone to determining cause of low flow alarms.Rhc showed normal numbers and patient was taken off sildenafil and weaned from milrinone.The low flow alarms returned.A second rhc off milrinone demonstrated right venticular failure.Milrinone was resumed at.05 mcg/kg/min.No additional information has been submitted.

Manufacturer Narrative

A direct correlation between the device and the reported event could not be determined through this evaluation.The patient remains ongoing on vad support.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.A review of the device history records revealed the device met applicable specifications.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: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7571659
• MDR Text Key: 110170860
• Report Number: 2916596-2018-02335
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Model Number: 106524
• Device Catalogue Number: 106524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 63