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

Model Number	104911
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Renal Failure (2041); Heart Failure/Congestive Heart Failure (4446)
Date of Event	07/28/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient passed away due to failure to thrive, progressive renal failure, and systolic and diastolic heart failure.The death was considered to be device/therapy related.The pump was not explanted, and the device parameters were stated to be within normal limits for the patient.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a direct correlation between heartmate ii left ventricular assist system (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 current revision of the ifu and patient handbook can be found on the eifu page of the abbott website.The heartmate ii left ventricular assist system (hmii lvas) instructions for use (ifu) is currently available.Section 1, ¿introduction¿, lists potential adverse events, including renal dysfunction and death, that may be associated with the use of the heartmate ii left ventricular assist system.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.

• 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: 50277091
• Report Number: 2916596-2026-2918922
• Device Sequence Number: 9753048
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: (01)00813024011170(17)160131
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/17/2026

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: 01/31/2016
• 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: 07/28/2026
• Initial Report FDA Received Date: 08/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2013
• 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: 83 YR
• Patient Sex: Female
• Patient Weight: 220 LB