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

Model Number 106015

Device Problem Partial Blockage (1065)

Patient Problems Death (1802); Hemolysis (1886); Thrombus (2101)

Event Date 02/20/2018

Event Type  Death  

Manufacturer Narrative

This report is a continuation of patient's thrombus, device exchange and death previously reported under mfr# 2916596-2018-00889.History of thrombus previously reported under mfr # 2916596-2017-02829.Approximate age of device- 2 years, 1 month.The device was returned for investigation.The evaluation is not yet complete.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 on (b)(6) 2016.It was previously reported that the pump showed intermittent increase in flows and power.It was reported on (b)(6) 2018 that the patient's lactate dehydrogenase (ldh) levels continued to rise despite treatment with bivalirudin.A kink was seen in the outflow graft via 3d imaging.It was noted that the patient had a history of pump thrombosis.The patient underwent a pump exchange on (b)(6) 2018.On (b)(6) 2018, the family decided to withdraw care and the patient expired.The cause of death was reported as post-surgical complications.No issues were reported with the second pump.No further information was provided.(b)(4) was received on 04feb2019.This complaint is being recreated for the evaluation of the pump.

• 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
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 8352558
• MDR Text Key: 136579155
• Report Number: 2916596-2019-00687
• 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
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

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: Health Professional
• Device Expiration Date: 10/31/2018
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 05/31/2019
• Supplement Dates FDA Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2015
• 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): Death; Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 118