MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9000TFX23A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Aortic Regurgitation (1716); Hematoma (1884); Thrombus (2101)

Event Date 12/18/2013

Event Type  Injury  

Event Description

Per the field clinical specialist (fcs) report, approximately 20-30 minutes after the implantation of a 23 mm sapien valve in a 50:50 position, the echocardiologist noted severe central aortic insufficiency (cai) which had slowly progressed post deployment.The physician scrubbed back in to attempt to use a pigtail catheter to manipulate the non-moving non coronary leaflet.Then angiogram noted a peri valvular aortic hematoma with thrombus noted in the sapien valve.The physician attempted to remove clot with mp and al1 guide catheters and a small amount was detected upon removal.It was decided with much discussion to stop the procedure and the friable lv apex was closed.Per report, the aortic annulus diameter measured 22 mm by tee with moderate calcification.During the procedure the act was above 250.The patient was stable at the end of the procedure.Per the latest report, a tee was performed a couple of days post tavr and the thrombus was no longer present.The patient was extubated and remains in stable condition.Additional information provided noted the annulus diameter was 22 mm via tee with moderate native valve / leaflet and root calcification.The valve was positioned and deployed in an 50:50 position.The coaxial alignment of the delivery system / valve and image intensifier angle during deployment were reported as good.

Manufacturer Narrative

Per the instructions for use (ifu) valve regurgitation, cardiovascular injury, hematoma, valvular thrombosis, and calcification or thrombus are potential adverse events associated with transcatheter aortic valve replacement and bioprosthetic heart 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.According to the mayo clinic, some causes for thromboembolism include advanced age, atherosclerosis, cancer, previous mi, heart failure, dm, htn, a sedentary lifestyle, certain medications, and smoking.According to the valve academic research consortium (varc), valve regurgitation can result from a number of factors, including, but not limited to pannus, calcification, support structure deformation (out-of-round configuration), endocarditis, prosthetic valve thrombosis, and native leaflet prolapse impeding prosthetic leaflet motion.The edwards sapien transfemoral delivery system training guide instructs the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Factors that can contribute to impaired leaflet coaptation include over inflation of the deployment balloon and native leaflet overhang.The patient screening manual instructs the operator on proper native valve leaflet assessment, taking into consideration the length, bulkiness and distribution of calcium on the native leaflets to determine whether sapien valve performance will be impaired.The available literature addressing peri-aortic hematomas following transcatheter aortic valve replacement (tavr) indicate that there are several possible etiologies and potential contributing factors, including the presence of bulky calcification, potentially causing calcification to be pushed against the aortic wall during inflation of the balloon; certain anatomic features, including the disparity between the volume of cusp calcium and the volume of the sinus of valsalva; clinical features, including advanced age, female gender and small body weight; deformation of the wall of the aorta during balloon inflation; exacerbation by intra-procedural hypertension immediately following tavr; ¿overstretching¿ of the annulus and/or the aortic root; and size mismatch between the native aortic annulus and transcatheter heart valve diameters.In this case, the cause of the reported events cannot be confirmed, and imaging of the procedure was not available for edwards lifesciences to review.Without imaging, patient factors (native valve calcification), and procedural factors (imaging intensifier angle, valve deployment position, confirmation of leaflet motion restriction or overhang) could not be confirmed/assessed.It is possible that during deployment, the sapien valve and balloon pushed a piece of calcium against the aortic valve structure leading to a peri-aortic hematoma.Per report the act was above 250 during the procedure; however, an unappreciated variation in the coagulation during the procedure may have occurred which in combination with the formation of a hematoma could have caused or contributed to the development of thrombus which affected leaflet coaptation and lead to the cai.There was no allegation or indication that the events are related to a manufacturing defect.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a (b)(4) basis, and any excursions above the control limits are assessed and documented as part of this (b)(4) review.No corrective or preventative actions are required.

• Brand Name: EDWARDS SAPIEN TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: deborah deutsch ; 1 edwards way; irvine, CA 92614 ; 9497564213
• MDR Report Key: 3568434
• MDR Text Key: 4074851
• Report Number: 2015691-2014-00090
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/18/2013

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2015
• Device Model Number: 9000TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2013
• Initial Date FDA Received: 01/10/2014
• Date Device Manufactured: 03/04/2013
• 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): Required Intervention