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

Model Number 106524

Device Problems Restricted Flow rate (1248); Material Twisted/Bent (2981)

Patient Problem Syncope (1610)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

The heartmate 3 lvas was implanted during the (b)(6) clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The gtin unique device identifier for the commercial heartmate 3 lvas is (b)(4).Approximate age of device- 2 years, 11 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) 2016.Log file analysis stated the event log for heartmate3 patient contained mainly pulsatility index events as well as a single low flow estimate on (b)(6) 2019.No other abnormal alarms or events were recorded.The patient was having syncopal episodes.A computed tomography angiography was done and a twist was observed by the physician reading the images.Since the patient has been admitted, they had increased his pump speed, performed right heart catheters which show his cardiac output is equal to his pump flow.Labs have stayed normal throughout stay.Computed tomography angiography showed a bit of a shadow at outflow graft but nothing conclusive.Patient was bumped up to status 3.No known cause of the pulsatility index events.Patient had echos, right heart catheters and computed tomography angiography while in patient; none showed a definite twist.Flows were equal to cardiac output on his catheters.Labs including lactose dehydrogenase normal.Patient was discharged home.

Event Description

It was reported that the cardiovascular (cv) surgeon looked at the computed tomography angiography and saw a shadow at the outflow but it was later determined this was not a twist.

Manufacturer Narrative

Multiple attempts were made to obtain patient weight information but this information was not provided.Additional information: manufacturer's investigation conclusion: although the report of low flow was confirmed through evaluation of the submitted log files, a root cause could not be conclusively determined through this evaluation.Furthermore, a correlation between the device and the reported syncopal episodes could not be conclusively determined.The account reported the patient was having syncope and was admitted for suspected low flows and suspicion of outflow graft twist.The account later reported that a ct angiography was performed and no outflow graft twist was observed.Log file evaluation revealed a transient low flow fault on 26jun2019 at 4pm, as a result of the estimated flow falling below the low flow threshold of 2.5lpm.The low flow event did not last long enough to trigger an alarm.A root cause could not be conclusively determined.The system operated above the low speed limit for the duration of the log file.The heartmate 3 lvas ifu explains all system alarms, including the low flow hazard alarm, and the recommended actions associated with them.Per design, when the flow value is calculated at less than 2.5 lpm, a low flow status is posted to the log file.A 10-second delay is imposed between the detection of the low flow status and the activation of the associated audio and visual indicators on the system controller.The heartmate 3 lvas patient handbook instructs the patient that in the event of a low flow hazard alarm, call your hospital contact immediately for diagnosis and instructions.Furthermore, it also explains that physiological factors that affect the filling of the pump, such as hypovolemia or postural hypotension, can result in reduced pump flows as long as the condition persists.The account later reported the patient felt fine while walking and had their pump speed increased.They were discharged home and remains ongoing on vad support with no further related issues reported.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: 8819089
• MDR Text Key: 152019841
• Report Number: 2916596-2019-03370
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: 106524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR