MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number	103693
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Hemorrhage/Blood Loss/Bleeding (1888); Intracranial Hemorrhage (1891); Muscle Weakness/Atrophy (1967); Speech Disorder (4415); Hemorrhagic Stroke (4417)
Date of Event	11/06/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient was admitted to hospital with neurological symptoms.During investigation at the hospital, they saw that the patient had metastasis in brain that were bleeding.The patient expired at the hospital.It was stated that no treatment could be done.The cause of death was cerebrovascular accident.It was unknown whether an autopsy would be performed, and the pump was not to be explanted.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
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 determined through this evaluation.The relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate ii left ventricular assist system (lvas) instructions for use (ifu), rev.A is currently available.Section 1, ¿introduction¿, lists potential adverse events, including stroke, bleeding, and death, that may be associated with the use of the heartmate ii left ventricular assist system.The ifu also outlines the suggested anticoagulation regimen and inr range that should be maintained for patients using the heartmate ii lvas, as well as the suggested anticoagulation modifications in the event there is a risk of bleeding.The current revision of the ifu can be found on the eifu page of the abbott website.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was further communicated that the stroke was hemorrhagic.The patient had catastrophic brain bleeding from brain metastasis.They had common neurologic symptoms including impaired speech and hemiplegia.The death was not considered to be device related and was stated to have operated as expected.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23682305
• Report Number: 2916596-2025-07709
• Device Sequence Number: 9715884
• Product Code: DSQ
• UDI-Device Identifier: 00813024010616
• UDI-Public: (01)00813024010616
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2025

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: 06/30/2012
• Device Model Number: 103693
• Device Catalogue Number: 103693
• 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: 11/20/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2009
• 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 Sex: Male
• Patient Weight: 72 KG