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

Catalog Number 106015

Device Problem Partial Blockage (1065)

Patient Problems Hemolysis (1886); Thrombus (2101)

Event Date 12/26/2017

Event Type  Injury  

Manufacturer Narrative

The initial submission of this event was reported by the manufacturer under mfr.Report # 2916596-2018-00299.This report is being submitted as additional information.4 years and 5 months (age of device) the report of thrombus and elevated ldh could not be confirmed through this evaluation.The account reported that the patient was admitted with elevated ldh.A ramp echocardiogram revealed that the pump was not unloading properly.The patient underwent a pump exchange on (b)(6) 2018 and it was reported that thrombus was visualized on the inlet bearing.Multiple attempts for product return were sent to customer and the pump was not returned to abbott for analysis.The heartmate ii lvas ifu lists device thrombosis and hemolysis as adverse events that may be associated with the use of the heartmate ii left ventricular assist system.This document also describes how pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.This document additionally provides information regarding anticoagulation therapy and the recommended inr range and outlines indications of pump thrombosis, as well as how to respond to such events.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.

Event Description

The patient was implanted with a left ventricular assist device on (b)(6) 2013.It was reported that the patient was admitted to the hospital for elevated lactate dehydrogenase (ldh).A ramp echocardiogram revealed that the pump was not unloading properly.The patient underwent a pump exchange on (b)(6) 2018.Thrombosis was confirmed in the operating room on the inlet bearing.No additional information provided.

• 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
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• MDR Report Key: 7712595
• MDR Text Key: 114798765
• Report Number: 2916596-2018-02711
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 07/23/2018
• Supplement Dates Manufacturer Received: 01/16/2019
• Supplement Dates FDA Received: 01/23/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/22/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 99