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

Model Number	106015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/21/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient passed away.The cause of death was unknown.The patient was with a friend in a car and reported not feeling well.1 minute later the friend looked over and patient's head dropped and body slouched forward and the pump began to continuously alarm.911 was called and it was indicated the patient's pupils were fixed and dilated by the time emergency medical services (ems) arrived.Ems performed cardiopulmonary resuscitation (cpr) for 55 minutes without achieving return of spontaneous circulation (rosc).The kind of alarm was unknown as by the time a ventricular assist device (vad) coordinator was contacted, ems had already performed cpr for 55 minutes, and the alarm history would have been overwritten by low flows associated with ems stopping cpr.The system controller was disposed as it was soiled with blood.The pump was not explanted.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a direct correlation between heartmate ii left ventricular assist system, serial number (b)(6), and the reported patient outcome could not be conclusively established through this evaluation.The cause of death was unknown, and it was unknown if the death was device related.It was also unknown if the device operated as expected.It was noted that no log files are available and the system controller was disposed as it was soiled with blood.Additionally, the account indicated that no product will be returned for evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specification.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu) rev.A, and the heartmate ii patient handbook rev.A, are currently available.Section 1, "introduction", lists adverse events, including death, that may be associated with the use of the heartmate ii left ventricular assist system.Section 8 of the patient handbook, ¿handling emergencies¿, also provides examples of emergencies and the proper actions to take in the event an emergency occurs.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE®, 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 ; 7818528207
• MDR Report Key: 24810983
• Report Number: 2916596-2026-01866
• Device Sequence Number: 16122722
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: (01)00813024011224(17)200228
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: 02/28/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 5998502
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2017
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 59 KG