MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LVAS IMPLANT KIT; VENTRICULAR (ASSIST) BYPASS

Model Number 106524US

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 03/04/2024

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Event Description

It was reported that the patient had an outflow track thrombus.Log files were submitted for review and captured low flow events on (b)(6).The calculated flow appears to have fluctuated below the alarm threshold of 2.5 lpm.Some of the low flow events were not sustained for long enough (at least 10 seconds) to activate the audible alarm.

Manufacturer Narrative

Manufacturer¿s investigation conclusion: the report of outflow graft thrombus cannot be confirmed through this evaluation.Additionally, low flow alarms were confirmed through review of the submitted log files.A specific cause for the reported alarms could not be conclusively determined through this evaluation.The patient remains ongoing on heartmate 3 left ventricular assist system (lvas), serial number (b)(6).No further issues have been 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 heartmate 3 lvas instructions for use (ifu) is currently available.Section 1 of the ifu, ¿introduction¿, lists the adverse events, including thromboembolism, that may be associated with the use of the heartmate 3 left ventricular assist system.Section 4, ¿system monitor,¿ explains that the low flow hazard alarm occurs when pump flow is less than 2.5 liters per minute (lpm).A 10-second delay is imposed between the detection of the low flow status and the activation of the associated audio and visual indicators on the system controller.Changes in patient conditions can result in low flow.Section 6, ¿patient care and management¿, also lists thromboembolism as a potential late postimplant complication.Additionally, this section, under ¿anticoagulation¿, provides the recommended anticoagulation regimen, including inr values, as well as suggested anticoagulation modifications.Section 7, ¿alarms and troubleshooting,¿ explains all system alarms and the recommended actions associated with them.The heartmate 3 lvas patient handbook also outlines all system controller alarms as well as how to respond to each alarm condition.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 3 LVAS IMPLANT KIT
• Type of Device: 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: 18988379
• MDR Text Key: 338730894
• Report Number: 2916596-2024-01569
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024013297
• UDI-Public: 00813024013297
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/10/2021
• Device Model Number: 106524US
• Device Lot Number: 6781842
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White