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

Model Number 106524INT

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/31/2019

Event Type  Injury  

Manufacturer Narrative

The approximate age of the device is 9 months.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) 2018.It was reported that the patient was admitted to the hospital for low flow alarms.Log files confirmed minimal flow through the pump.A ct scan showed that the outflow graft was normal, with no twisting.Thrombus of the pump was subsequently confirmed via ct, echo, and ramp tests.The abbott clinical specialist recommended a pump exchange.Due to the patient's comorbidities and will, the healthcare providers decided on lysis therapy.The therapy has since been performed, but has not had any measurable impact.The patient remains asymptomatic.The lvad was shut down but not explanted and the patient was discharged in stable condition.

Manufacturer Narrative

The report of a thrombus formation could not be confirmed as no product was returned and no images were provided for analysis.Although the evaluation of the submitted log files confirmed the report of low flow alarms, a specific cause for these events could not be conclusively determined through this evaluation.Evaluation of the controller periodic log file captured calculated flow ranging between 5.2 and 6.4 lpm until (b)(6) 2019 03:21:53 pm, when calculated flow appeared to slowly decrease to values as low as 0 lpm.The controller event log file captured a nearly persistent calculated flow of 0 lpm starting on (b)(6) 2019 at 08:45:47 am.A persistent low flow hazard alarm was also observed during this time, associated with the calculated flow decreasing below the low flow threshold of 2.5 lpm.Despite the observed low flow events, the pump appeared to have functioned as intended throughout the duration of the log files.The heartmate 3 lvas ifu lists possible pump thrombosis as an adverse event that may be associated with the use of heartmate 3 left ventricular assist system.This document also lists thromboembolism as a potential late postimplant complication.This ifu contains information regarding the recommended anticoagulation therapy and inr range.In addition, this document 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.This ifu and the heartmate 3 lvas patient handbook explain all system alarms and the recommended actions associated with them.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: 8338355
• MDR Text Key: 136109041
• Report Number: 2916596-2019-00573
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• 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: 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Model Number: 106524INT
• Device Catalogue Number: 106524INT
• Device Lot Number: 6240411
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention