MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS INSPIRIS RESILIA AORTIC VALVE; REPLACEMENT HEART VALVE

Model Number 11500A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Arrest (1762); Death (1802); Thrombosis (2100)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to edwards for evaluation.Attempts to retrieve the device are in process.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.Valve thrombosis is a rare and well-recognized complication of prosthetic valves.Valve thrombosis is the formation of significant blood clots forming on the valve.These clots could significantly impact the functionality of the valve resulting in heart failure or thromboembolism.Immediate intervention, either by thrombolytic therapy or valve replacement is required for significant thrombosis.Alternatively, there may be cases where the patient is placed on an anticoagulant to treat thrombosis.Based on the information received the cause cannot be determined.If additional information is received a supplemental mdr will be submitted.Edwards will continue to review and monitor all events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards received notification a 23mm aortic valve was explanted due to thrombosis.Approximately one hour after implantation the patient had a cardiac arrest requiring heart massage and reopening the patient.On explant, the surgeon noticed that the valve presented many blood clots on the ventricular side, there was an acute thrombosis.As per the surgeon, biologic evaluation and multiple blood sampling was performed, but the etiology of the event remained unknown.The patient died.As reported, the surgeon is convinced this is not an allergy to heparin, as they did not find any thrombus in the ecc or ecmo.The valve was explanted while the patient was still alive.

Manufacturer Narrative

Additional manufacturer narrative: an observational evaluation was performed on the returned valve.Most of the tissue on one of the leaflets (leaflet 3) was removed from the valve.So no functional evaluation is feasible.The leaflet appeared to be removed post explant as the valve was still intact in the post explant pictures provided by the hospital.There is a thin layer of fibrin-like thrombotic material covered most of outflow surface of leaflets 1 and 2.Several smaller similar thrombotic depositions were noted on the inflow surface of the remaining two leaflets.Most of the red blood cells (rbcs) observed on the pictures provided by the hospital did not present on the retuned valve as the rbcs were most likely ¿washed off¿ during the subsequent process post explant.The leaflets appear to be still pliable with slightly increase in stiffness that may be exaggerated due to the subsequent storage in formalin.Radiographs demonstrated the wireform and cocr band are intact and the vfit cocr alloy band is not expanded.The radiograph confirmed the size of the valve is 23 mm.Sewing ring cloth and silicone band damages observed are most likely related to the valve explant.It is very rare for this type of bioprosthetic heart valve to develop thrombosis as observed in this particular valve.Based on the observational evaluation findings and the available information on the case, the specific cause(s) for the thrombotic materials observed on the valve could not be determined at this time.

Event Description

Edwards received notification a 23mm aortic valve was explanted due to thrombosis leading to main left coronary artery occlusion.The intervention went very well and the patient was hemodynamically stable.Approximately one hour after implantation the patient had a sudden cardiac arrest with electro mechanical dissociation and required immediate resuscitation maneuvers.The patient was transferred for surgery with sternotomy and cpb.The left ventricle was found stopped in systole.On explant, the surgeon noticed that the valve presented many blood clots on the ventricular side, there was an acute thrombosis.The aortic bioprosthesis had a thin layer of thrombus covering both sides of the valve, extensive to the main left coronary artery.The main left coronary artery occlusion explained the dissociation.At this point, the patient was noted to be still alive.The aortic valve was replaced with a 21mm edwards magna ease aortic valve.The aortic was declamped after 69 minutes.Unfortunately, the heart never restarted, the cpb was prolonged for 3 hours, followed by extracorporeal membrane oxygenation (ecmo).After 1h45 of ventricular assistance, the reanimation was stopped.The patient death was considered to be the consequence of the main left coronary artery occlusion.As per the surgeon, biologic evaluation and multiple blood sampling was performed, but the etiology of the event remained unknown.As reported, the surgeon is convinced this is not an allergy to heparin, as they did not find any thrombus in the ecc or ecmo.Prior to the valve intervention, the patient was noted as having a major risk for thromboembolism.

Manufacturer Narrative

Customer report of thrombosis was confirmed due to observed fibrin material.As received, approximately 95% of leaflet 3 had been cut out.The cuts had smooth and even edges.Both leaflets 1 and 2 had fibrin-like deposits, with the majority observed on the outflow aspect.The x-ray demonstrated the wireform and cocr band to remain intact; the vfit cocr alloy band was not expanded.The sewing ring was cut near leaflet 2 and around commissure 1, and exposed the wireform at the inflow aspect near commissure 1.The valve was not received in the same condition as in the images provided by the customer.The valve still retained all three leaflets as seen on the images.The color images provided included two pictures of the inflow aspect, and one picture of the outflow aspect.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.The device has been sent for further testing and analysis.A supplemental report will be submitted accordingly once the evaluation has been completed.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: EDWARDS INSPIRIS RESILIA AORTIC VALVE
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 8173356
• MDR Text Key: 130626922
• Report Number: 2015691-2018-05367
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• PMA/PMN Number: P150048/S021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2020
• Device Model Number: 11500A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 55 YR