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 Codes	Ischemia (1942); Renal Failure (2041); Septic Shock (2068); Cardiac Tamponade (2226); Cardiogenic Shock (2262); Bacteremia (4846)
Date of Event	06/30/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient's course was reported to be complicated by cardiac tamponade despite multiple chest closure/washouts.The patient had cardiogenic shock from (b)(6) 2026 until (b)(6) 2026 , acute respiratory distress syndrome (ards) requiring veno-venous extracorporeal membrane oxygenation (vv ecmo) occurred from (b)(6) 2026 until (b)(6)2026, and tracheostomy placement occurred on (b)(6) 2026.The patient was later found to have profound lactic acidosis with septic shock due to gram-negative rod bacteremia on 19july2026, mesenteric ischemia on 20jul2026, severe coagulopathy on 20jul2026, and acute renal failure on crrt that was deemed unsurvivable from 30jun2026 until 20jul2026.After discussion with the family at the bedside, the decision was made to transition to comfort care to alleviate patient suffering in the setting of a non-survivable condition.The patient ended up passing away due to septic shock as a result of gram-negative rod bacteremia.The outcome was considered therapy related.The pump was not explanted.The device operated as expected.
Additional Manufacturer Narrative
Due to system limitations, the following codes were not included in section h6: 1696 - adult respiratory distress syndrome 1779 - coagulation disorder.Manufacturer's investigation conclusion: a direct correlation between heartmate 3 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 relevant sections of the device history records for (b)(6) were reviewed and showed no deviations from manufacturing or quality assurance specifications.The current revisions of the instructions for use (ifu) and patient handbook can be found on the eifu page of the abbott website.The heartmate 3 lvas ifu and the heartmate 3 lvas patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including infection (local, driveline, and pump pocket), pericardial fluid collection, and renal dysfunction, that may be associated with the use of the heartmate 3 left ventricular assist system.Section 6 of the ifu, ¿patient care and management¿, lists infection as a potential late postimplant complication.Furthermore, several sections of the hm3 ifu and patient handbook provide care instructions regarding how to prevent infection as well as suggested responses in the event of infection.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: 50461897
• Report Number: 2916596-2026-2919095
• Device Sequence Number: 18594691
• Product Code: DSQ
• UDI-Device Identifier: 05415067039323
• UDI-Public: (01)05415067039323(17)270902
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 08/26/2026

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 Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: L00004882
• 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: 08/05/2026
• Initial Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/31/2025
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 118 LB
• Patient Race: White