MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, LVAS IMPLANT KIT (WITH SEALED GRAFTS); Ventricular (assist) bypass

Model Number	104911
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fatigue (1849); Hemorrhage/Blood Loss/Bleeding (1888); Unspecified Infection (1930); Drug Resistant Bacterial Infection (4553)
Date of Event	08/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: a specific cause for the patient's infection could not conclusively be determined through this evaluation.Further, a direct correlation between heartmate ii left ventricular assist system (lvas), serial number (b)(6), and the patient¿s low hemoglobin and hematocrit levels could not be conclusively established through this evaluation the patient remains ongoing on heartmate ii lvas, serial number (b)(6), with no further events reported at this time.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 revision of the ifu can be found on the eifu page of the abbott website.The heartmate ii lvas ifu, and the heartmate ii patient handbook are currently available.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including bleeding and infection (local, driveline, or pump pocket), that may be associated with the use of the heartmate ii left ventricular assist system.Section 6 of the ifu, "patient care and management", lists infection as a potential late postimplant complication.Section 6 (under ¿anticoagulation¿) also provides the recommended anticoagulation regimen, including international normalized ratio (inr) range, as well as suggested anticoagulation modifications.Furthermore, several sections of the heartmate ii ifu and patient handbook provide care instructions regarding how to prevent infection as well as the suggested responses in the event an infection occurs.No further information was provided.The manufacturer is closing the file on this event.
Event or Problem Description
It was reported that the patient had low hemoglobin and hematocrit.It was said the patient had blood transfusions.They also had an incision and drainage as well.The blood transfusion improved the low hemoglobin and hematocrit.The onset of the infection was (b)(6) 2022 (the onset of the infection is covered under manufacturer report number: 2916596-2023-05254).The patient had fatigue, and the source of the infection was pump pocket.Drainage and methicillin-resistant staphylococcus aureus (mrsa) was identified.The infection was being treated with ertapenem intravenous and was not resolved.It was planned to continue treating the patient with ertapenem intravenous.

• Brand Name: THORATEC® HEARTMATE II®, LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23451212
• Report Number: 2916596-2025-06663
• Device Sequence Number: 8057107
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: (01)00813024011170
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 11/03/2025

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 Expiration Date: 03/31/2016
• Device Model Number: 104911
• Device Catalogue Number: 104911
• 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: 10/08/2025
• Initial Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2013
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 84 KG