MAUDE Adverse Event Report: Thoratec Corporation THORATEC® HEARTMATE II®, LVAS IMPLANT KIT (WITH SEALED GRAFTS); Ventricular (Assist) Bypass

Model Number	104911
Medical Device Problem Codes	Disconnection (1171); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/07/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient's wife found the patient down and disconnected form their power source with no alarms active at the time.The patient's wife stated that she was sleeping in a different room and never heard any alarms.She believed the patient was possibly getting up for the restroom, got confused and could not get themselves on batteries properly.The patient passed away.Log files were sent for review and captured the driveline disconnect and the pump not operating.The driveline was disconnected on (b)(6) 2026 at 10:30.The pump operated at he set speed for the remainder of the log file which ended on (b)(6) 2026 at 4:18 with low battery advisory and hazard events.It was unknown if the device would be returned for evaluation.
Additional Manufacturer Narrative
Section d4: expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• Brand Name: THORATEC® HEARTMATE II®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• 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 ; +1(781)852-8207
• MDR Report Key: 50484244
• Report Number: 2916596-2026-2919180
• Device Sequence Number: 10093461
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: (01)00813024011170(17)130901
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/01/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/01/2013
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/07/2026
• Supplement Date Received by Manufacturer: 08/27/2026; 09/23/2026
• Initial Report FDA Received Date: 08/27/2026
• Supplement Report FDA Received Date: 09/17/2026; 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2011
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 198 LB