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

Model Number	106015
Medical Device Problem Codes	Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Mitral Valve Stenosis (1965); Thrombosis/Thrombus (4440); Pulmonary Valve Insufficiency/ Regurgitation (4452)
Date of Event	03/11/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Event or Problem Description
It was reported that the patient's log files were submitted for review.The log files contained a few pulsatility index (pi) events as well as routine power source changes.The mechanical circulatory support (mcs) equipment operated as intended.It was later communicated that the patient passed away due to a catastrophic intracerebral hemorrhage.An echocardiogram (echo) showed an ejection fraction of 20-25%, right ventricular mild decreased systolic function, mitral valve mild mitral stenosis, aortic valve suture closed, and pulmonic valve trace regurgitation.The computed tomography (ct) results showed a stable large left parietal intraparenchymal hemorrhage that included approximately 4 to 5 mm of rightward midline shift.The outcome was not considered to be device or therapy related and operated as expected.
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 patient outcome could not be conclusively determined through this investigation.The submitted log file contained no atypical alarms and appeared to show the pump operating as intended.The current revision of the ifu can be found on the eifu page of the abbott website.The heartmate ii lvas ifu, is currently available.Section 1 of the ifu, ¿introduction¿, lists stroke, right heart failure, and death, as an adverse event that may be associated with the use of the heartmate ii lvas.This section also addresses pump speed, power, flow, and pi (pulsatility index), and explains that pump power is a direct measurement of motor voltage and current.Changes in pump speed, flow, or physiological demand can affect pump power.Changes in pump speed, flow, or physiological demand can affect pump power.Section 6, under ¿anticoagulation¿, provides information regarding the recommended anticoagulation therapy and international normalized ratio (inr) range, as well as suggested anticoagulation modifications.Section 6 also explains that pump performance is sensitive to changes in systemic vascular resistance and left ventricular filling.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®, 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: 24651380
• Report Number: 2916596-2026-01625
• Device Sequence Number: 18591194
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: (01)00813024011224(17)181031
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2026

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: 10/31/2018
• 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: 03/11/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/20/2026
• Supplement Report FDA Received Date: 03/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2015
• 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: Required Intervention; Life Threatening; Death
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 91 KG