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

Catalog Number 106015

Device Problem Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Date 06/23/2016

Event Type  malfunction  

Manufacturer Narrative

Patient identifier was not available.Approximate age of device ¿ 21 days.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 during log file review by the manufacturer¿s technical services representative a pump stop associated with a driveline disconnect was observed.Per the technical services representative, if this was not a true driveline disconnect there was a short to shield issue.There were no other unusual events seen within the log file.No additional information was provided.

Manufacturer Narrative

Manufacturer investigation conclusion: evaluation of the submitted log file confirmed a pump stop and low flow alarms.A specific cause for the low flow alarms could not be conclusively determined through this evaluation.Log file analysis showed a driveline disconnect resulting in a pump stop was captured on (b)(6) 2018.A specific cause for the driveline disconnection could not be conclusively determined through this evaluation.Transient low flow alarms were also captured on (b)(6) 2018 due to the estimated flow range falling below the low flow threshold of 2.5lpm.The device was explanted due to the patient receiving a heart transplant.The device was functionally tested and functioned as intended.The heartmate ii instruction for use (ifu) warns that disconnection of the driveline would result in a pump stop.The heartmate ii left ventricular assist system ifu explains all system alarms and how to troubleshoot them should they occur.This document also explains that pump flow is estimated from the pump power and that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.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.A review of the device history records revealed the device met applicable specifications.No further information was provided.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: 7653391
• MDR Text Key: 112849829
• Report Number: 2916596-2018-02684
• 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: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 120