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 Codes	Thrombosis/Thrombus (4440); Lactate Dehydrogenase Increased (4567)
Date of Event	05/30/2025
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 there was a suspected pump thrombus.Log files were sent for review.The event log captured routine events.The ventricular assist device (vad) and peripheral equipment appeared to have functioned as intended.A speed change was noted back on (b)(6) 2025 from 9400 to 9800 revolutions per minute (rpm).There was also elevated lactate dehydrogenase (ldh), amber urine, and an abnormal ramp/rpm echocardiogram (echo).
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the report of suspected pump thrombus could not be confirmed through this evaluation.The submitted log file contained data from (b)(6) 2025.No notable events or alarms were captured, and the pump appeared to function as intended at or above the low-speed limit for the duration of the file.Multiple attempts were made to obtain additional information regarding the reported events; however, no additional information was provided.The patient remains ongoing on heartmate ii left ventricular assist system (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 heartmate ii lvas ifu and the heartmate ii patient handbook are currently available.The current revisions of the instructions for use (ifu) and patient handbook can also be found on the electronic ifu (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 (inr) range.This section 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: 22235793
• Report Number: 2916596-2025-03837
• Device Sequence Number: 8177009
• Product Code: DSQ
• UDI-Device Identifier: 00813024011996
• UDI-Public: (01)00813024011996(10)10501915(17)260507
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 07/18/2025

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: 05/07/2026
• Device Model Number: 107801
• Device Catalogue Number: 107801
• Device Lot Number: 10501915
• 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: 06/02/2025
• Supplement Date Received by Manufacturer: 07/17/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 07/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2024
• 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: 58 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White