MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA

Model Number 106015

Device Problems Partial Blockage (1065); Kinked (1339); Device Stops Intermittently (1599)

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

Event Date 05/17/2018

Event Type  Injury  

Manufacturer Narrative

Approximate age of device- 2 years and 3 months.The patient remains ongoing with the lvad 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) 2016.It was reported that the patient presented to the emergency room due to persistent low flow alarms which occurs while connected to battery and on the mobile power unit (mpu).The manufacturer¿s technical services representative reviewed the submitted log file and reported 232 low flow events observed.Within the log file there were also 2 pump stops and 3 low speed operations taking place on (b)(6) 2018 at 9:05, (b)(6) 2018 at 9:22, and (b)(6) 2018 11:12.During these events it appears the patient is on the power module.On (b)(6) 2018, the patient underwent an outflow graft replacement.Yellow, fibrous material was found between graft and bend relief, kink found at aortic anastamosis.Graft replaced via sternotomy and the patient¿s chest was closed.No additional information was provided.

Manufacturer Narrative

The report of low flow alarms was confirmed based on review of the submitted log file; however, a specific cause could not be conclusively determined through this evaluation.The report of yellow, fibrous material was found between graft and bend relief, kink found at aortic anastomosis could not be confirmed.No product was returned for analysis.Images or photographs that may have been taken by the user facility during the outflow graft replacement procedure were not provided to the manufacturer for analysis.The pump remains implanted and the patient remains ongoing on vad support.The heartmate ii lvad instructions for use (ifu) explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling, explains that pump flow is estimated from pump power, and addresses assessing pump flow.This ifu also contains important warnings regarding the prevention of outflow graft kinks and twists.A review of the device history records revealed the device met applicable specifications.No further information is available.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM, NA
• Type of Device: LEFT VENTRICULAR ASSIST SYSTEM
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7598825
• MDR Text Key: 110998347
• Report Number: 2916596-2018-02448
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• 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: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2018
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 69