MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, SYSTEM CONTROLLER; VENTRICULAR (ASSIST) BYPASS

Model Number	106762
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that driveline fault alarms on 03dec2025 lasted for 3 hours.The patient reported to be doing well, denied any heart failure (hf) symptoms or alarms.The log files were submitted for review.It appeared that the log file captured driveline fault events on 03dec2025 that are intermittent and may possibly indicate an issue with one of the six driveline wires.Additionally, heartmate ii log files were submitted for review.The log file captured the system controller exchange.The log file did not capture any additional driveline faults.The clinician reported that the submitted x-rays did not show any areas of concern.They reported no further alarms since last clinic visit.They changed both the system controllers, as the patient tolerated the exchange.They did the multiple disconnections and obtained log files.They noted (b)(6) was the primary system controller during the driveline fault.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of driveline fault alarms occurring on the system controller (serial number (b)(6)) was confirmed via log file analysis.The provided log files captured intermittent driveline fault alarms on 03dec2025.These alarms appeared to have been caused by phase 1 measuring higher than phases 2 and 3, and the alarms resolved when phase 1¿s values decreased to be more in sync with the other two phases.Data consistent with a system controller exchange taking place on 16dec2025 was also captured in the submitted log files.No other notable events were observed.The returned system controller passed functional testing and successfully operated in a mock circulatory loop for an extended period of time without any issues or atypical alarms produced.Available information provided that both of the patient¿s system controllers were exchanged, and no further driveline fault alarms were reported after the exchanges.Multiple attempts were made to obtain additional information regarding this event; however, no responses were received.The root cause of the reported event was unable to be conclusively determined through this investigation.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 left ventricular assist device (lvas) instructions for use (ifu), rev.A and the heartmate ii patient handbook, rev.A are currently available.The current revision of ifu and patient handbook can be found on the eifu page of the abbott website.The heartmate ii lvas instructions for use (section 7 ¿alarms and troubleshooting¿) and the heartmate ii patient handbook (section 5 ¿alarms and troubleshooting¿) instructs users on how to resolve alarms that sound from their system controller, including alarms associated with driveline fault conditions.Heartmate ii patient handbook cautions users 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.
Event or Problem Description
Additional log files were submitted on 13jan2026 and there were no unusual events recorded.The mechanical circulatory support (mcs) equipment appeared to have operated as intended.

• Brand Name: THORATEC® HEARTMATE II®, SYSTEM CONTROLLER
• 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 24059230
• Report Number: 2916596-2026-00299
• Device Sequence Number: 21187456
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: (01)00813024011286(17)250305
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/20/2026

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: 03/05/2025
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 8413471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 02/06/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2022
• 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: 79 YR
• Patient Sex: Male
• Patient Weight: 73 KG