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	Bacterial Infection (1735)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
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 was admitted on (b)(6) 2026 and (b)(6) 2026 for an ongoing driveline infection.On (b)(6) 2026, swab culture grew 3+ methicillin-susceptible staphylococcus aureus (mssa).Computed tomography (ct) was also performed, showing a mild amount of stranding in the left lower quadrant subcutaneous abdominal wall, around the driveline wire.No fluid collection.Otherwise, no acute abnormality in the chest, abdomen, and pelvis.In (b)(6) 2026 a more recent swab grew multiple corynebacteria, including an amycolatum species with resistance to oral antibiotics, a ct on (b)(6) 2026 showed no focal fluid collection or fat stranding surrounding the driveline.Mild skin thickening near the entry point of the driveline could be related to cellulitis.The plan was to continue cefadroxil for ongoing mssa suppression which would likely be indefinite antibiotic therapy.

• 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: 50885521
• Report Number: 2916596-2026-2919930
• Device Sequence Number: 13427942
• Product Code: DSQ
• UDI-Device Identifier: 05415067039323
• UDI-Public: (01)05415067039323(17)270503
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 09/24/2026

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: L00003693
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/12/2025
• 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: Life Threatening; Hospitalization
• Patient Age: 23 YR
• Patient Sex: Female
• Patient Weight: 149 LB
• Patient Race: Black Or African American