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 06/19/2018

Event Type  Death  

Manufacturer Narrative

Approximate age of device- 29 days.The patient remains ongoing with the lvad device.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) 2018.On (b)(6) 2018, it was reported that the patient was admitted to the hospital from a rehabilitation facility for suspected thrombus.The patient presented with tea colored urine with a large amount of blood present, but no heart failure symptoms.On admission, the patient¿s lactate dehydrogenase (ldh) was greater than 1200 u/l with inr of 2.6.The customer aggressively treated the patient with intravenous anticoagulation to dissolve thrombus.On (b)(6) 2018, the patient¿s ldh was 1111 u/l and urine was yellow vs tea colored.On (b)(6) 2018, it was reported that the patient¿s ldh increased again to 1300¿s u/l after trending down to 800¿s u/l over the weekend and the patient¿s urine color was back to cola colored.On an unspecified date, the patient elected to be discharged to home, as the patient was not a surgical candidate for a pump exchange or a transplant candidate.As of (b)(6) 2018, the patient was at home and being monitored closely.The patient was active and had no heart failure symptoms.The patient¿s ldh remained in 1800¿s u/l down from 2200 u/l and urine was periodically dark and red to yellow.The patient is on warfarin, aspirin, and plavix.It was reported that the patient accepted risks of thrombus and wanted to be home.No additional information was provided.Multiple log files submitted and reviewed by the manufacturer¿s technical services representative revealed power and flow trending upward with pi trending downward.The most recent log file submitted on (b)(6) 2018 showed consistent pump powers above baseline in the 7-9w range.

Manufacturer Narrative

(b)(4).The lvad was disposed after expiration.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

Additional information: it was reported that the patient expired at home on (b)(6) 2018.The patient was not a surgical candidate for another exchange therefore at the time of expiration the family requested the lvad disconnected and disposed.At the time of the patient's expiration, low flow alarms were observed on the system controller.The patient's last ldh drawn was below 2900u/l and blood specimen had brown serum therefore was unable to be rerun.

Manufacturer Narrative

Manufactures investigation conclusion: the device was not returned to the manufacturer for analysis as the user facility reported it was disposed of.Although review of the submitted log files showed elevations in pump power and estimated flow, a specific cause could not conclusively be determined through this evaluation.A direct correlation between correlation between the device and the reported event could not conclusively be established through this evaluation.Device thrombosis and hemolysis are listed in the instructions for use as potential adverse events that may be associated with the use of heartmate ii left ventricular assist system.This document also provides information regarding the recommended anticoagulation therapy and inr range and also outlines indications of pump thrombosis as well as how to respond to such events.This instructions for use explains that pump power is a direct measurement of motor voltage and current; therefore, changes in pump speed, flow, or physiological demand can affect pump power.This document also describes how pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.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 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: 7688226
• MDR Text Key: 114008778
• Report Number: 2916596-2018-02783
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/31/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6307006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2018
• 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): Death; Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 85