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

Model Number 106524INT

Device Problems Mechanical Problem (1384); Decreased Pump Speed (1500); Material Twisted/Bent (2981); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Thrombosis/Thrombus (4440)

Event Date 12/20/2023

Event Type  Injury  

Event Description

It was reported that the patient had chest pain and no associated alarms and was hospitalized due to suspected left ventricular assist device (lvad) graft torsion.They had an echocardiogram and computed topography performed.They also performed laboratory tests and elevated troponins were evident.The device was interrogated and there were no significant alarms.A computed tomography angiography was taken, and it was evident that there is a torsion of the lvad graft and also a thrombus in the aortic valve.It was noted that there were no changes to patient condition or anticoagulation status that may have contributed to the thrombus.Right catheterization and pressure measurement were carried out where there were no changes in the right and the presence of the thrombus in the same position in the aortic valve was evident.It was noted that the patient was implanted in 2018 when the facility did not have the clip to avoid torsion.The only thing that was noticed when interrogating the lvad with the system monitor was that the speed sporadically changed from 5600 to 5200 rpm.The patient remained hospitalized, without inotropic support, and received an intravenous unfractionated heparin drip; coagulation goals of 2.5-3 international normalised ratio (inr) were achieved.They were hemodynamically stable and without alarms.A plan was made to monitor and surveille risk factors and it was being determined whether it should be taken to surgical management.The patient would be discharged on (b)(6) 2024.

Manufacturer Narrative

A2 and a4 - patient age and patient weight not provided.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported outflow graft torsion and aortic valve thrombus could not be confirmed through the evaluation of the submitted video.Additionally, the reported changes in pump speed could not be confirmed as no log files were provided for review.A specific cause for the speed changes could not be conclusively determined.Furthermore, a direct correlation between heartmate 3 left ventricular assist system (lvas), serial number (b)(6), and the reported events could not be conclusively determined through this evaluation.The patient remains ongoing on heartmate 3 lvas, serial number (b)(6), and no further related events have been reported at this time.Corrective actions have been implemented to address heartmate 3 outflow graft twist.(b)(6) was implanted prior to the implementation of these corrective actions.The relevant sections of the device history records for mlp-012009 were reviewed and showed no deviations from manufacturing or quality assurance specifications.The heartmate 3 left ventricular assist system (lvas) instructions for use (ifu), rev.G and the heartmate 3 patient handbook, rev.G, are currently available.Section 1 of the ifu, "introduction," lists potential adverse events, including peripheral thromboembolic events, which may be associated with the use of heartmate 3 lvas.Section 1 of the ifu also outlines all pump parameters, including pump speed.Section 1 notes that the heartmate 3 employs a feature called artificial pulse.Although the clinician will set only a single speed, the rotor speed will periodically depart from this value (2000 revolutions per minute (rpm) above and 2000 rpm below the set speed) in order to contribute a flow disruption that in some ways mimics native cardiac contractility.Section 6, ¿patient care and management¿ (under ¿anticoagulation¿), provides the recommended anticoagulation regimen, including inr range, as well as suggested anticoagulation modifications.This section also lists thromboembolism as a potential late postimplant complication.Section 5 of the ifu, ¿surgical procedures¿, outlines considerations for pump placement and provides instructions regarding the preparation, installation, and orientation of the sealed outflow graft.Section 5, under "attaching the sealed outflow graft to the pump," instructs the user to verify that the graft is not twisted or kinked by checking the position of the black line on the graft above and below the bend relief and ensuring that the line is straight.Section 5, under "preimplant procedures" and "implant procedures" cautions the user: "the sealed outflow graft must not be kinked or positioned where it could abrade against a pump component or body structure" and "stretch the sealed outflow graft completely prior to measuring and cutting the graft to the appropriate length." although the device was reportedly implanted prior to the implementation of the outflow graft clip, the heartmate 3 lvas ifu, rev.C includes instructions for installing the outflow graft clip, and states to attach the outflow graft clip to prevent post-operative outflow graft twisting.This section further warns that failure to install the outflow graft clip so that it is flush with the bend relief can allow graft twisting or abrasion which may lead to serious adverse events such as bleeding, graft occlusion, thrombosis, and/or death.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: 18456944
• MDR Text Key: 332213354
• Report Number: 2916596-2023-08957
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 03/20/2024

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/01/2021
• Device Model Number: 106524INT
• Device Lot Number: 6596861
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 03/19/2024
• Supplement Dates FDA Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FA-Q118-MCS-1
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female