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

Model Number	106524US
Medical Device Problem Codes	Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Coagulation Disorder (1779); Hemorrhage/Blood Loss/Bleeding (1888); Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446); Kidney injury (4882); Compartment syndrome (4888)
Date of Event	09/03/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported the pump was replaced on (b)(6) 2026.Post-operatively, the patient required ongoing mechanical ventilation, sedation and paralytics, with significant chest tube output, coagulopathy, and metabolic acidosis managed with blood products, protamine, and volume resuscitation.The patient developed abdominal compartment syndrome with bladder pressure of 40 mmhg, which led to an inability to achieve adequate left ventricular assist device (lvad) or veno-venous extracorporeal membrane oxygenation (vv ecmo) flow.After extensive discussion with the family, the patient underwent emergent bedside exploratory laparotomy on (b)(6) 2026 with abdominal dressing placement, revealing viable bowel and significant serosanguinous fluid.There was initial improvement in both the lvad and vv ecmo flows, but then the lvad began to have low flows once again.Transesophageal echocardiogram (tee) was completed at the bedside, concerning for right ventricular (rv) failure.After more discussion with the family, including risks, benefits, and alternatives, vv ecmo was converted to veno-pulmonary (vp) ecmo with percutaneous right ventricular assist device (rvad) placement via right internal jugular vein on (b)(6) 2026.Lvad flows improved post-procedure, but the patient remained critically ill and volume dependent.The patient continued to have large volume output from the abdominal dressing and bilateral chest tubes, pulmonary hemorrhage, and ongoing coagulopathy, requiring massive transfusion of blood products including packed red blood cells (prbcs), fresh frozen plasma (ffp), platelets, and cryoprecipitate, as well as ddavp (desmopressin) and albumin.Nephrology was consulted for acute kidney injury (aki) and oliguria, and continuous renal replacement therapy (crrt) was initiated.Despite aggressive management, the family elected to transition to comfort care measures on (b)(6) 2026, and withdrawal of life support was performed with family at bedside.The patient passed away.
Additional Manufacturer Narrative
Section d4: device lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• 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: 50926938
• Report Number: 2916596-2026-2920171
• Device Sequence Number: 9498441
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: (01)00813024013297
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/29/2026
• 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 Age: 59 YR
• Patient Sex: Male
• Patient Weight: 147 LB