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

Model Number 106524US

Device Problem Insufficient Information (3190)

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

Event Date 02/23/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: review of the controller event log file retrieved from the returned system controller confirmed multiple lvad fault events.The log file contained data from 15:39 to 16:17 on (b)(6) 2022.The majority of the log file, encompassing 235 lines of data, occurred during a 1-minute time frame between 15:39 and 15:40.All of these events were due to an intermittent lvad fault, which was repeatedly activating and clearing in less than one second.The events did not result in an alarm but did fill the log file rapidly.The lvad faults resolved without any intervention from a user and did not reoccur during the remainder of the log file.The pump operated as intended at the set speed for the duration of the log file up until the driveline was disconnected as part of a controller exchange.Review of the controller periodic log file found that the lvad faults were not active in the hours preceding the event log file.Although the cause of the intermittent lvad fault events could not be determined, the events did not appear to have an effect on pump operation.A direct correlation to the reported difficulty downloading the log files also could not be determined.The relevant sections of the device history records were reviewed and showed no deviations from manufacturing or qa specifications.Although no alarm resulted from the event, heartmate 3 instructions for use outlines all system alarms, including the lvad fault advisory, and the recommended actions associated with these events in the alarms and troubleshooting section.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that log file review of the system controller revealed a left ventricular assist device (lvad) software fault on (b)(6) 2022 from 15:39:54 to 15:40:55.

• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15135973
• MDR Text Key: 302287231
• Report Number: 2916596-2022-12631
• 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
• Report Date: 07/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/10/2023
• Device Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: 8136409
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• 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 Age: 38 YR
• Patient Sex: Male
• Patient Weight: 161 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American