MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VENTRICULAR (ASSIST) BYPASS

Model Number 106015

Device Problem Mechanical Problem (1384)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 01/18/2024

Event Type  Death  

Event Description

It was reported that log files were submitted and evaluation revealed a few unsustained power and flow elevations between 18jan2024 and 24jan2024.There were no other unusual events recorded in the log file event history.It was later reported that the patient passed away on (b)(6) 2024 and the cause of death was left ventricular assist device (lvad) thrombosis.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Manufacturer Narrative

E1: reporter phone number was not available.Manufacturer's investigation conclusion: the report of suspected pump thrombus could not be confirmed through this evaluation.Additionally, analysis of the submitted log files confirmed elevated pump power and estimated flow values; however, a specific cause for this finding could not be conclusively determined.The submitted log files contained events from 04jan2024 through 04feb2024.Elevated pump power and estimated flow values were captured on 18jan2024.No other notable events or alarms were captured.The pump appeared to function as intended at the fixed speed.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no additional information was provided.The device was not returned for evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii lvas instructions for use (ifu) is currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including device thrombosis and death, that may be associated with the use of the heartmate 3 left ventricular assist system.The hmii lvas ifu contains information regarding pump speed, power, flow, and pulsatility index (pi).The ifu 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.Abrupt changes in power should be evaluated for cause.This document also describes how pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.Additionally, section 6 "patient care and management" outlines the recommended anticoagulation therapy and inr range.This section also outlines indications of pump thrombosis, as well as how to respond to such events.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18897068
• MDR Text Key: 337586180
• Report Number: 2916596-2024-01195
• 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: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: 106015
• Device Lot Number: 5786116
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2016
• 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
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 147 KG