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

Model Number	103695
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that log files were sent for evaluation due to concern for pump thrombus.The data that was reviewed did not contain attributes which would lead to suspect the presence of thrombus within the motor chamber; however, that does not mean that thrombus was not present in the circulatory loop.It was recommended to look at other clinical indications that may confirm the presence of thrombus.
Additional Manufacturer Narrative
No further information provided.A supplemental report will be submitted once the manufacturer investigation is complete.
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 events and data from day 976 through day 983.No notable alarms or events, or significant fluctuations in pump parameters were captured.The pump appeared to function as intended and operated at or above the low-speed limit for the duration of the file.The patient remains ongoing on heartmate (hm) ii left ventricular assist system (lvas), serial number (b)(6).No further related events have been reported at this time.The heartmate ii lvas instructions for use (ifu) lists device thrombosis as an adverse event which may be associated with the use of heartmate ii lvas and provides information regarding the recommended anticoagulation therapy, as well as suggested anticoagulation modifications.This document also outlines indications of pump thrombosis as well as how to respond to such events.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 (hm) ii left ventricular assist system (lvas) instructions for use (ifu)and the heartmate ii patient handbook 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 (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.
Event or Problem Description
An echocardiogram was performed but thrombus was not confirmed.The patient had no symptoms related to thrombus.The patient was given heparin and tissue plasminogen activator drops.There was no plan of care.

• Brand Name: THORATEC® HEARTMATE II®, LVAS IMPLANT KIT, US, EP
• 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: 20451900
• Report Number: 2916596-2024-06799
• Device Sequence Number: 20634118
• Product Code: DSQ
• UDI-Device Identifier: 00813024010616
• UDI-Public: (01)00813024010616(17)131231
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 12/10/2024

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: 12/31/2013
• Device Model Number: 103695
• Device Catalogue Number: 103695
• 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: 10/04/2024
• Supplement Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 10/15/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2011
• 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: Other
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 133 KG