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

Model Number 9300TFX23J

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Arrhythmia (1721); Cardiac Arrest (1762); Death (1802); Thrombus (2101); Ventricular Fibrillation (2130)

Event Date 01/16/2015

Event Type  Injury  

Event Description

It was reported by our (b)(4) affiliate that during a transfemoral tavr procedure, post implantation of a 23mm sapien xt valve, thrombosis was found attached to the valve frame struts.The sapien xt was implanted with 3.5ml less than nominal volume.The sapien xt was expanded towards the ventricular side, leaving a trapezoidal shape.Due to the calcification, the operator judged that there would be a low risk of migration but a high risk of rupture if post dilatation was performed so the delivery system was removed.Tee showed mild pvl.Angiography then demonstrated remarkable regurgitation around the bulky calcification.When the guidewire was removed, thrombus was observed on the aortic side of the sapien xt.The thrombus was ¿swinging¿ but it appeared attached to the sapien xt valve.The act was kept at 280 seconds while the team waited for the thrombus to resolve.After about 5 minutes post implantation, thrombus formation appeared to have worsened and was almost circumferentially on the struts but not attached to the cusps.A valve in valve was considered but it was decided to monitor the patient and continue heparin and warfarin administration, and the procedure was concluded.The operator commented that the patient might have been plavix resistant.The echocardiographer commented that stagnation of blood was observed in the left atrium pre-procedure.No thromboses were observed at that time, but there might have been conditions that promoted thrombus formation.The next weekend, the patient experienced r-on¿t phenomenon and developed ventricular fibrillation.The patient also developed heart failure, which improved with continuous hemodiafiltration.However, on pod 12, the patient died as a result of continued arrhythmias.

Manufacturer Narrative

Edwards lifesciences continues to investigate the reported event and a supplemental report will be submitted in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

Pre-screening ct, and procedural cine and echo were reviewed by an edwards physician proctor; however the 2d tee images provided were still images and therefore the reported thrombosis could not be viewed.Impression: it is not possible to confirm the cause for the reported thrombus.Concur with ct measurements provided with the original report.Based on severe calcium and annular measurements, this was a borderline case (between sapien xt 23mm and 20mm).Bav with the 20mm balloon demonstrated that the correct valve was a 20mm valve, as there was no leakage of contrast into the ventricle during inflation, and the sapien xt valve was not fully expanded during deployment, as evidenced by under nominal volume (-3 cc) and a waist on the balloon during inflation.Per the instructions for use (ifu), thrombosis is a rare and well-recognized complication associated with the use of 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.Anticoagulation therapy must be evaluated patient by patient.The cause for valve thrombosis is thought to result from an interaction between components of blood and the prosthesis or turbulent blood flow in and around the prosthesis.Several factors can cause early or later development of thrombosis, including: inadequate anticoagulant therapy after valve implant, atrial fibrillation, medications, cancerous tumors, systemic diseases (e.G, systemic lupus erythematosus, inflammation and damage to various body tissues, including joints, skin, kidneys, heart, lungs, blood vessels, and brain), and reduced cardiac pumping (low ejection fraction).Thrombosis has an extremely low incidence rate in bioprosthetic heart valves.It is a complex process triggered by the interaction between the host and the device and is highly variable among patients.Since the mechanism of thrombotic deposition on bioprosthetic heart valves is not fully understood, the cause cannot always be confirmed.During the manufacturing process, all edwards valves are 100% visually inspected for defects and are 100% tested for coaptation prior to release for distribution.This makes it highly unlikely that a manufacturing defect or device malfunction would contribute to the event.In this case, the cause of the very early valve thrombosis cannot be confirmed; however, the original report indicated that the patient might have been plavix resistant, and the echocardiographer noted stagnation of blood in the left atrium pre-procedure.No clotting was observed at that time, but it was considered possible that there might have been conditions that promoted thrombus formation.These factors, in combination with frame underexpansion, may have contributed to the thrombosis reported.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; therefore no further actions are required.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: EDWARDS SAPIEN XT 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: 4505119
• MDR Text Key: 5412620
• Report Number: 2015691-2015-00275
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/16/2015

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: 10/08/2018
• Device Model Number: 9300TFX23J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 02/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death; Required Intervention
• Patient Age: 89 YR