MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE®, LVAS IMPLANT KIT (WITH SEALED GRAFTS); Ventricular (assist) bypass

Model Number	106015
Medical Device Problem Codes	Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Altered State of Consciousness (4589)
Date of Event	01/21/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported low flow alarms could not be confirmed as no log files were submitted for review.A specific cause for the events could not be conclusively determined through this evaluation.Additionally, a direct correlation between heartmate ii lvas, serial number (b)(6), and the reported events and subsequent patient outcome could not be conclusively established through this evaluation.Multiple attempts were made to obtain additional information regarding the reported event; however, no further information was provided by the customer.The heartmate ii left ventricular assist system (hmii lvas) instructions for use (ifu), and hmii lvas patient handbook, are currently available.Section 1, ¿introduction¿, lists potential adverse events, including neurological dysfunction (not stoke-related) and death, that may be associated with the use of the heartmate ii left ventricular assist system.This section also provides an explanation of all pump parameters, including pump flow.Section 4 of the ifu, ¿system monitor¿, provides more information regarding all pump parameters and also describes situations which may result in a low flow hazard alarm, including changes in patient conditions.Per design of the system, once each monitoring cycle, the calculated average flow value is compared to the limit (2.5 liters per minute (lpm)).If the calculated value is less than the expected value, a low flow hazard is posted to the log file.A ten second delay is imposed between the detection of a low flow hazard alarm condition and the activation of the associated audio and visual indicators on the controller.This document also lists neurologic dysfunction as a potential late postimplant complication.Section 7 of the ifu, ¿alarms and troubleshooting¿, and section 5 of the patient handbook, ¿alarms and troubleshooting¿, outline all system controller alarms, including the low flow hazard alarm, and provides information regarding how to respond to and troubleshoot the alarms.The current revision of the ifu and patient handbook can be found on the eifu page of the abbott website.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the patient passed away at (b)(6) on (b)(6) 2026.The hospital notified of pending patient transfer due to nausea and vomiting, abdominal pain, low flow alarms and altered mental status (ams), however their family declined to transfer and decided to change their code status to do not resuscitate (dnr)/ do not intubate (dni).

• 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: 24735508
• Report Number: 2916596-2026-01517
• Device Sequence Number: 18747246
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: (01)00813024011224(17)201130
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/30/2026

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: 11/30/2020
• Device Model Number: 106015
• Device Catalogue Number: 106015
• Device Lot Number: 6270418
• 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: 03/09/2026
• Initial Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/18/2017
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 124 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American