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

Model Number 106015

Device Problems Partial Blockage (1065); High Readings (2459)

Patient Problem Thrombus (2101)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Approximate age of device ¿ 26 days.The pump remains in use supporting the patient.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) 2017.It was reported that high pump power and flow events had been occurring since (b)(6) 2017.The patient did not have any signs or symptoms of hemolysis, lactate dehydrogenase (ldh) was fine and their urine was clear.The manufacturer's technical services representative reviewed the submitted system controller log file and the data showed a type of trajectory that has been linked to the possible presence of thrombus.On (b)(6) 2017, it was reported that the elevated powers were still occurring.Ldh was normal at 300 u/l.There were no other signs of hemolysis.The patient was still slightly hypervolemic.The patient had been diuresed for approximately one week; however, there was no changes in the parameters.The aortic valve was closed with each cardiac cycle.On (b)(6) 2017, it was reported that the system controller was exchanged and pump parameters changed.The pump powers initially did not improve but they normalized overnight.It was reported that there was concern for device obstruction.On (b)(6) 2017, the patient was discharged to a rehabilitation center.

• 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: kathy reilly ; 6101 stoneridge dr.; pleasanton, CA 94588 ; 9257380163
• MDR Report Key: 7016313
• MDR Text Key: 91759517
• Report Number: 2916596-2017-02693
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• 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
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 106015
• 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: 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/16/2017
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 110