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 Codes	Fall (1848); Hematoma (1884); Intracranial Hemorrhage (1891)
Date of Event	03/09/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a direct correlation between the 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.The device was not returned for evaluation.Multiple attempts were made to obtain additional information regarding the reported events; however, no additional information was provided by the account.The relevant sections of the device history records for (b)(6) documents were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii lvas ifu, document rev.A is currently available.The current revisions of the instructions for use (ifu) and patient handbook can also be found on the electronic ifu (eifu) page of the abbott website.Section 1 of the ifu, "introduction", lists potential adverse events, including bleeding and death, that may be associated with the use of the heartmate ii left ventricular assist system.Section 6, under "anticoagulation", provides information regarding the recommended anticoagulation therapy and international normalized ratio (inr) range, as well as the suggested anticoagulation modifications.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 in (b)(6) 2026 due to traumatic subdural hematoma (sdh) and subarachnoid hemorrhage (sah) which was likely due to a fall that occurred at their home.The patient¿s family decided to transition to comfort measures due to the patient's condition continuing to deteriorate.

• 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: 24702791
• Report Number: 2916596-2026-01511
• Device Sequence Number: 10109603
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: (01)00813024011224(17)170118
• 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: 2014
• 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): 03/26/2026

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: 01/18/2017
• Device Model Number: 106015
• Device Catalogue Number: 106015
• 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: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2014
• 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: 77 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic