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

Catalog Number 106524INT

Device Problem Partial Blockage (1065)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

Fda approval for heartmate 3 lvas was received on 23 august 2017.(b)(4).Approximate age of device ¿ 1 year and 4 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.It was reported that on (b)(6) 2018, the patient was admitted to the hospital due to outflow graft stenosis.No further information was provided.

Manufacturer Narrative

Additional information the patient remains ongoing on lvad support.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Additional information: it was reported that the patient received stents in the outflow graft which opened up the diameter of the graft.Good flow was established and the patient was discharged home.No additional information was provided.

Manufacturer Narrative

The device remains in use and was not available for evaluation.The report of low flow alarms can be confirmed based on the submitted log files; however, the reported of an outflow graft stenosis cannot be confirmed.The system controller event log file captured numerous low flow events, where the calculate average flow was captured at 2.4 lpm or lower.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.Similar events were captured in the controller periodic log file.Two additional system controller log files were submitted which captured the device operating as expected at the set speed of 5500 rpm.The instructions for use (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 patient remains ongoing on heartmate 3 lvas and no further events have been reported.A review of the device history records, including the sterilization and packaging documentation, found no deviations from manufacturing specifications.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 7312923
• MDR Text Key: 101485930
• Report Number: 2916596-2018-00838
• 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,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• 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 Catalogue Number: 106524INT
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 63