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

Model Number	107801
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had a known driveline fault and log files were sent for review.There were no changes in patient clinical status and no acute concerns.The log file contained the reported ongoing driveline faults.The pump appeared to be maintaining the set speed and operating within normal parameters.The log file also contained multiple low flow hazard events.The flow readings did not appear to be the result of any external equipment malfunction.There were no other unusual events recorded in the log file event history.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer's investigation is complete.
Additional Manufacturer Narrative
Section e3 - occupation: corrected.Manufacturer's investigation conclusion: review of the submitted log file confirmed the reported driveline fault alarms; however, a specific cause for the alarm could not be conclusively determined through this evaluation.The submitted log file contained events from 01jun2025 through 16jun2025.A driveline fault associated with a yellow wrench advisory was active for the entirety of the file.These events did not appear to impact pump function, and the pump appeared to operate as intended above the low-speed limit for the duration of the file.No other notable events or alarms were captured.Multiple attempts were made to obtain additional information regarding the reported events; however, no additional information was provided by the account.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 ifu is currently available.The current revisions of the instructions for use (ifu) and patient handbook can also be found on the electronic ifu (eifu) page of the abbott website.Section 7 of the ifu, "alarms and troubleshooting", outlines system controller alarms, including driveline faults, as well as how to respond to each alarm condition.Section 5 of the patient handbook, ¿alarms and troubleshooting¿, outlines system controller alarms as well as how to respond to each alarm condition.Section 8 of the patient handbook, ¿handling emergencies¿, lists examples of emergencies and the recommended actions associated with these emergencies.Furthermore, the patient handbook instructs the user to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE II®, LVAS IMPLANT KIT
• Common Device Name: 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: 22439243
• Report Number: 2916596-2025-04165
• Device Sequence Number: 3201244
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: (01)00813024011996(17)210228
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: 107801
• Device Catalogue Number: 107801
• Device Lot Number: 6501028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/14/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Weight: 60 KG