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

Model Number 106524US

Device Problem Partial Blockage (1065)

Patient Problem Thrombus (2101)

Event Date 06/09/2018

Event Type  Injury  

Manufacturer Narrative

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 heartmate 3 lvas is (b)(4).Approximate age of device: 86 days.The patient remains ongoing with the device.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.The patient presented to the hospital on (b)(6) 2018 to be evaluated after the lvad system produced a low flow alarm that occurred when the patient was sitting down watching tv.Flow was down to 2.5 lpm and pi elevated at 12.The alarm stopped on its own after 30 seconds.The customer reported that the patient¿s inr had been consistently subtherapeutic for the last 2 weeks (goal 1.5-2) and there was concern for lvad thrombus.The patient was admitted and started on a heparin drip.An echocardiogram performed on (b)(6) 2018 was suboptimal to assess for lvad thrombus.A 2-view cxr showed stable left pleural effusion.The low flow alarm did not recur and the patient¿s lactate dehydrogenase (ldh) levels remained stable.It was reported that lisinopril was increased to 20 mg daily and amlodipine decreased to 5 mg daily in response to an elevated mean arterial pressure (map).The manufacturer's technical services representative reviewed the log file provided by the customer which contained data from (b)(6) 2018 to (b)(6)2018 and observed a low flow flag on (b)(6) 2018, which did not stay below the 2.5 lpm threshold long enough to trigger an audible alarm.Multiple intermittent pi events were also observed.Other than the low flow flag and intermittent pi events, no other unusual were seen.The patient was asymptomatic.The patient was discharged to home on (b)(6) 2018 in stable condition.The patient was instructed to continue taking usual warfarin dose at home.A follow-up clinic visit was scheduled for 18jun2018.

Event Description

It was reported that the patient's follow-up appointment on (b)(6) 2018 went as expected with no further issues.The patient's echo ramp study was normal and the team will continue to monitor with scheduled appointments.

Manufacturer Narrative

Manufacturer's investigation conclusion: the pump remains in use supporting the patient and was not available for evaluation.A correlation between the device and the report of hemolysis and suspected thrombus could not be conclusively determined.The reported transient power elevations were confirmed per the evaluation of submitted log files; however, the cause for the power elevations could not be conclusively determined.Thrombus and hemolysis are listed in the instructions for use as a potential adverse event that may be associated with the use of the heartmate ii left ventricular assist system.A review of the device history records revealed that 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: 7668157
• MDR Text Key: 113388436
• Report Number: 2916596-2018-02480
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/05/2019
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 6160219
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 70