MAUDE Adverse Event Report: Thoratec Corporation Thoratec® HeartMate 3® LVAS Implant Kit; Ventricular (Assist) Bypass

Model Number	106524US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/31/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported through the research article ¿discharge prescription for neurohormonal blockade and clinical outcomes in heartmate 3 lvad recipients after device implantation¿ identifying that the heartmate 3 (hm3) may be related to death/mortality and heart failure readmission.This is a single-center retrospective study where 273 patients who underwent hm3 left ventricular assist device (lvad) implantation were evaluated.Of the 273 patients, 138 (50%) received a prescription for at least one neurohormonal blockade agent after index discharge.Patients who received neurohormonal blockade at index discharge had longer survival compared with those who did not, at a median follow-up of 3.8 years.After multivariate adjustment, neurohormonal blockade at discharge demonstrated a trend toward a lower risk of mortality (hr 0.69; 95% ci, 0.44¿1.09; p=0.11).A discharge prescription for neurohormonal blockade was not associated with heart failure readmission.
Additional Manufacturer Narrative
Sections a and d: specific patient information and device serial number are documented as unknown.Details are listed in the attached article.Device was implanted at time of event.Date of event is approximate as the data were collected between 01jan2015 and 31dec2021.Tejada frisancho f, et al.Discharge prescription for neurohormonal blockade and clinical outcomes in heartmate 3 lvad recipients after device implantation.European heart journal.2025;46(suppl 1).Medstar washington hospital centre, washington, dc, united states of america.Manufacturer's investigation conclusion a direct correlation between the left ventricular assist device (lvad) devices and the reported outcomes could not be conclusively determined through this evaluation.The reported information was obtained through a literature review.The heartmate 3 device serial numbers and other specific case/patient information are not available.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.The heartmate 3 left ventricle assist system (lvas) instructions for use (ifu) is currently available.Section 1 of the ifu, ¿introduction,¿ lists potential adverse events, including death, that may be associated with the use of the heartmate 3 left ventricular assist system.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: Thoratec® HeartMate 3® 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: fredric gold ; 6035 stoneridge drive; pleasanton, CA 94588 ; +1(781)852-8207
• MDR Report Key: 50946984
• Report Number: 2916596-2026-2920100
• Device Sequence Number: 9534669
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 Model Number: 106524US
• Device Catalogue Number: 106524US
• 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: 09/21/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown