MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Model Number 106524

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982); Transient Ischemic Attack (2109)

Event Date 05/01/2018

Event Type  Injury  

Manufacturer Narrative

The patient's date of birth and age, gender and weight were not provided.Specific patient information and device serial number are documented as unknown.The serial number of the device was requested but was not provided, therefore the expiration date, manufacture date are unknown.Specific patient information and device serial number are documented as unknown.Device was implanted at time of event.Date of event is approximate as the data were collected between may 2008 and march 2018.Jl vieira, et al.The journal of heart and lung transplantation.Volume: 39, issue: 6, pages: 582-592 doi: 10.1016/j.Healun.2020.02.017.Heart and vascular center, brigham and women¿s hospital and harvard medical school, boston, usa.The results/method/conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported through the research article ¿the impact of statin therapy on neurological events following left ventricular assist system implantation in advanced heart failure¿ identifying that hm3 may be related to neurological events following the device implantation.This was a single center, retrospective and observational cohort study performed in 200 consecutive adults implanted with a durable continuous flow ¿ left ventricular assist support (cf-lvas) over a 10-year period (2008-2018).The end point of neurological events was defined as any temporary or permanent focal or global neurological deficit, including stroke (ischemic or hemorrhagic), or other acutely symptomatic neurological dysfunction without evidence of cell death by neuroimaging or pathology, such as transient ischemic attack (tia) or delirium.Overall, 24% of cf-lvas recipients developed at least 1 neurological event, at a rate of 0.11 events per patient-year (eppy) among those prescribed statins and 0.22 eppy among non-users (age-adjusted hazard ratio [hr] 0.46; 95% confidence interval [ci],0.24-0.88; p = 0.019).However, ischemic stroke rate in hm3 lvas recipients was similar to the rate in statin users who received a non-hm3 lvas (0.06 and 0.05 eppy, respectively).Rates of hemorrhagic stroke and other safety end points were not significantly different according to statin use.

Manufacturer Narrative

Manufactures investigation conclusion: a direct correlation between the heartmate 3 (hm3) left ventricular assist systems (lvas) in the study and the reported strokes and neurological events could not conclusively be established through this evaluation.Specific causes for the reported events could not conclusively be determined.The study looked at the use of statin therapy and subsequent occurrence of neurological events, including stroke, following continuous-flow left ventricular assist system (cf-lvas) implantation.The study compared patients by statin use and implanted device (heartware ventricular assist device (hvad), heartmate 3 lvas, heartmate ii (hmii) lvas).Overall, 24% of all participants experienced at least 1 neurological event.Incidence rates of both ischemic and hemorrhagic stroke were not statistically significantly different according to statin use in hm3s, though an inverse correlation between statin use and neurological events was found with hvads and hmiis.No product was evaluated under this complaint.The study referenced in the research abstract consisted of 200 continuous-flow left ventricular assist system patients, of which 38 were hm3 patients.The study included device implants between 2008-2018, but all hm3 patients were implanted after 2015.The hm3 device serial numbers and other specific case/patient information is not available and was not requested.The hm3 left ventricular assist system (lvas) instructions for use (ifu) lists adverse events that may be associated with the use of the heartmate 3 left ventricular assist system, including stroke and other neurological event (not stroke-related).It also lists neurological dysfunction as a potential late postimplant complication that may be associated with the use of the hm3 lvas, and provides information regarding anticoagulation, including recommended international normalized ratio (inr) values, and the suggested anticoagulation modifications in the event there is a risk of bleeding.

• Brand Name: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11167462
• MDR Text Key: 227529654
• Report Number: 2916596-2021-00167
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 106524
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention