MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS; LEFT VENTRICULAR ASSIST DEVICE

Catalog Number 106015

Device Problems Partial Blockage (1065); Kinked (1339)

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

Event Date 02/20/2018

Event Type  Death  

Manufacturer Narrative

Reference medwatch mfr # 2916596-2017-02829 for the history of thrombus.(b)(4).Approximate age of device ¿ 2 years and 1 month.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.It was 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.

Manufacturer Narrative

A direct correlation between the left ventricular assist system (lvas) and the reported event could not be conclusively determined.Hemolysis is listed in the instructions for use as a potential adverse event that may be associated with the use of the heartmate ii left ventricular assist system.A review of the device history records revealed that the device met applicable specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS
• Type of Device: LEFT VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 7818528390
• MDR Report Key: 7322785
• MDR Text Key: 101829816
• Report Number: 2916596-2018-00889
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2018
• Device Catalogue Number: 106015
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: (B)(4)
• Patient Outcome(s): Death
• Patient Age: 60 YR
• Patient Weight: 118