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	Gastrointestinal Hemorrhage (4476)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was admitted from the emergency room for gastrointestinal (gi) bleed on (b)(6) 2026.The patient initially presented to an outside hospital emergency room with a hemoglobin (hg of 6.5 and received 2 units of blood and was discharged at that time.The patient then presented to the implanting facility status post large volume dark bowel movement.The patient's hg/hematocrit (hct) was 9.2 g/dl and 28.6%, respectively.The patient did not receive any blood products.The patient's international normalized ratio (inr) was 1.4 at that time.On (b)(6) 2026, the patient underwent an esophagogastroduodenoscopy that showed a bleeding duodenal ulcer and gastritis.A proton pump inhibitor (ppi) was added.The patient's inr goal was decreased to 1.5-2.0, and the patient was deemed appropriate for discharge on (b)(6) 2026.
Additional Manufacturer Narrative
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: 50899397
• Report Number: 2916596-2026-2919836
• Device Sequence Number: 5829063
• Product Code: DSQ
• UDI-Device Identifier: 05415067039323
• UDI-Public: (01)05415067039323(17)271111
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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 Model Number: 106524US
• Device Catalogue Number: 106524US
• Device Lot Number: L00005829
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/09/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 162 LB
• Patient Race: White