MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 106524INT

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2024

Event Type  malfunction  

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

Related manufacturer report number: (b)(4).It was reported that on (b)(6) 2024 the patient called the hospital after noticing a very high flow of 20 lpm with a slight increase in power from 4 watts to more than 6 watts.The patient noted there was a very short beep from the system controller, but they did not see any alarms when they checked the system controller display.The patient stated to have felt fine at the time.The patient presented to the outpatient clinic and had their log files downloaded.An echocardiogram was also performed and no abnormalities were found.The log files confirmed the high flow value and increased power consumption.Additionally, the log files showed an event that occurred on (b)(6) 2024 around 1:30 pm where the pump internal parameters increased suddenly.The "lvad (left ventricular assist device) monitor iimc, lvad monitor pimc" took a big step upwards and "lvad monitor pi" had a very high peak around 120 coming from around 20.The flow calculation showed high values from 16-20 lpm.According to the log files, its possible the beep the patient heard as a driveline disconnect alarm that did not last longer than 1 second.These events were a rare case, so the log files were sent to other departments (us engineer department and r&d department in zurich) for further evaluation.It appeared there was reason to suspect there was an issue with one of the drive phases of the pump or also damage to it.This type of damage leaves a high risk for the rotor to not restart in the case of a pump stop.It was suggested that the patient's pump be exchanged.The patient was admitted for close observation and the decision for a pump exchange was not yet decided on by the patient's family.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• 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: 18981115
• MDR Text Key: 338629502
• Report Number: 2916596-2024-01846
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/02/2024
• Device Model Number: 106524INT
• Device Lot Number: 8427106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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