MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSIST) BYPASS

Model Number 106524

Device Problems Decreased Pump Speed (1500); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Syncope/Fainting (4411)

Event Date 03/11/2024

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient had frequent pulsatility index(pi) events and occasional speed drops to 5400 revolutions per minute (rpm) from 5600 rpm in the setting of syncopal events.No low flow alarms were seen on the device interrogation.The patient's mean arterial pressure (map) was stable in the 80s and their implantable cardioverter defibrillator (icd) was interrogated with no arrhythmia events.Log files were submitted for review and captured multiple pi events that were occurring on (b)(6) 2024 from 18:42:55 p.M.To 19:42:23 p.M.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6) , and the reported syncopal events could not be conclusively determined through this investigation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6).No further issues have been reported at this time.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 3 left ventricular assist system (lvas) instructions for use (ifu) is currently available.Section 1 of this document lists adverse events that may be associated with the use of the heartmate 3 left ventricular assist system.Section 1, ¿introduction,¿ provides an explanation of each of the pump parameters, including pulsatility index (pi), and pump flow.Under ¿pulsatility index (pi)¿, this section explains: ¿the pi calculation represents cardiac pulsatility.Pi values typically range from 1 to 10.In general, the magnitude of the pi value is related to the amount of assistance provided by the pump.Higher values indicate more ventricular filling and higher pulsatility (i.E., the pump is providing less support to the left ventricle).Lower values indicate less ventricular filling and lower pulsatility (i.E., the pump is providing greater support and further unloading the ventricle).¿ section 4 explains, "pi events are assumed by the system during cases when there are sudden and substantial changes in the pulsatility index.These events are also referred to as pi events, and may be initiated for reasons other than true pi events.Some reasons include sudden changes in a patient¿s volume status, arrhythmias, sudden changes in power, and sudden changes in pump speed." if the system detects a pi event, the pump speed automatically drops to the low-speed limit and slowly ramps back up at a rate of 100 rpm per second to the fixed speed setpoint.This drop in speed is accompanied by a reduced pump flow.There are no audible alarms with a pi event.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• 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: 19034495
• MDR Text Key: 339274050
• Report Number: 2916596-2024-01672
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2020
• Device Model Number: 106524
• Device Lot Number: 6036878
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/19/2017
• 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): Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 105 KG