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

Model Number 106015

Device Problems Partial Blockage (1065); Pumping Stopped (1503); High Readings (2459)

Patient Problems Unspecified Infection (1930); Thrombus (2101); No Known Impact Or Consequence To Patient (2692)

Event Date 06/20/2018

Event Type  Injury  

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2018.It was reported that the patient was hospitalized for a non-vad related issue.On (b)(6) 2018, a low flow alarm and pump stoppage occurred at approximately 4am.The patient was asymptomatic.The customer mentioned there was no audible alarm at the time of the event and there was no visible driveline damage.The manufacturer¿s technical service representative reviewed the submitted log file and observed that at 4:56am on (b)(6) 2018, there was a drop in speed followed by a pump stoppage.Prior to the event, there was an increase in power.The customer was informed that this could indicate that something passed through or was ingested into the pump causing the low speed operation and pump stoppage.The customer reported that the patient had ¿a lot going on¿ including an infection which may have predisposed the patient to a clot.As of (b)(6) 2018, the patient was well compensated and lactate dehydrogenase (ldh) was stable.Additional information was requested but not yet provided.

Manufacturer Narrative

(b)(4).The pump remains implanted supporting the patient.A review of the submitted log file confirmed the reported pump stoppage event.Elevations in pump power were also observed beginning on (b)(6) 2018, and remained elevated approximately 30 minutes before the pump stoppage event.A decrease in pulsatility index (pi) was also noted.Based on the manufacturer¿s previous complaint experience, the power changes and decrease in average pi could be indicative of device thrombosis.However, a direct correlation between the device and these findings could not conclusively be established through this evaluation.The instructions for use lists device thrombosis and infection as potential adverse events that may be associated with the use of heartmate ii left ventricular assist system, and provides information regarding the recommended anticoagulation therapy and inr range.It also 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.

• 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
• MDR Report Key: 7688704
• MDR Text Key: 114024509
• Report Number: 2916596-2018-02810
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 5784197
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR