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

Model Number	104911
Medical Device Problem Codes	Mechanical Problem (1384); Infusion or Flow Problem (2964)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	01/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4: device lot number was 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 info was provided.A supplemental report will be reported once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient had known outflow thrombus since (b)(6) 2023.The outflow thrombus was initially identified through a routine echocardiogram (echo).An echo and a gated computed tomography (ct) were used at the time for diagnostic testing.The patient was briefly placed on heparin.Log files were not available from the original event in 2023.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of suspected pump thrombus could not be confirmed through this evaluation as no diagnostic images were provided and no product was returned for evaluation.The patient remains ongoing on heartmate ii lvas, serial number (b)(6).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 revisions of the ifu and patient handbook can be found on the eifu page of the abbott website.The heartmate ii lvas ifu, rev.A and the heartmate ii lvas patient handbook, rev.A are currently available.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 (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: 23183783
• Report Number: 2916596-2025-06121
• Device Sequence Number: 15906387
• Product Code: DSQ
• UDI-Device Identifier: 00813024011170
• UDI-Public: (01)00813024011170(17)150731
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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: 07/31/2015
• Device Model Number: 104911
• Device Catalogue Number: 104911
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 10/29/2025
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2013
• 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: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 107 KG