MAUDE Adverse Event Report: THORATEC CORPORATION THORATEC® HEARTMATE II®, LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number	107801
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had a computed tomography angiography (cta) on (b)(6) 2025 where eccentric filling defect within the outflow cannula suspicious for thrombus was detected.There was nonocclusive thrombus within the left ventricular assist device (lvad) outflow.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the report of nonocclusive thrombus in the left ventricular assist device (lvad) outflow cannula could not be confirmed through this evaluation.Multiple attempts were made to obtain additional information regarding the event, no further information was provided by the account.The patient remains ongoing on heartmate (hm) ii left ventricular assist system (lvas), serial number (b)(6) 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 heartmate ii left ventricular assist device (lvas) instructions for use (ifu), rev a and the heartmate 3 patient handbook, rev.A are currently available.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Section 1 of the ifu, ¿introduction¿, lists potential adverse events, including device thrombosis, that may be associated with the use of the heartmate ii lvas.Section 6 of the ifu, "patient care and management," outlines the recommended anticoagulation therapy and international normalized ratio range.Section 6 also outlines indications of pump thrombosis, as well as how to respond to such events.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC® HEARTMATE II®, 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 23065203
• Report Number: 2916596-2025-05950
• Device Sequence Number: 9987584
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: (01)00813024011996(17)250204
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/04/2025
• Device Model Number: 107801
• Device Catalogue Number: 107801
• Device Lot Number: 10086801
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/20/2023
• 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: 56 YR
• Patient Sex: Female
• Patient Weight: 135 KG