MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 ULTRA, 26MM; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number 9750TFX26

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

Patient Problem Injury (2348)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by our affiliates in (b)(6), a 23mm sapien 3 ultra valve was implanted within a surgical ring in the mitral position with severe mitral regurgitation and a dehiscence at the level of the lateral commissure.After successful implant, tte showed central regurgitation.Post-dilation was performed which resolved the central regurgitation, but the dehiscence significantly increased.The patient was sent to surgery, the surgical ring and sapien 3 ultra valve were explanted, and a surgical valve was implanted.The patient recovered and was planned to be discharged.

Manufacturer Narrative

Correction to d2.Product code changed to npu.Per the instructions for use (ifu), central regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement (tvr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to central regurgitation including malposition of the valve, impingement of a leaflet due to the guide wire, over inflation of the deployment balloon, post dilation of the implanted valve, and slow recovery of adequate ventricular flow post valve deployment and rapid pacing.All of these factors have the potential to contribute to suboptimal coaptation of the sapien valve leaflets and cause central insufficiency.Occasionally there are cases where the root cause of the regurgitation cannot be determined.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.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 valve performance will be impaired.During the manufacturing process, all sapien valves are 100% visually inspected for defects and 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 exact cause of the central regurgitation is unknown.However, the regurgitation could be related to the mechanisms described above and/or placing the 26mm sapien 3 valve inside of a dehisced ring.The dehiscence was only exacerbated by the post dilation attempt and required explant of both devices.The valve placement was successful.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 monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA, 26MM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10932431
• MDR Text Key: 219155511
• Report Number: 2015691-2020-14811
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: 9750TFX26
• Device Catalogue Number: 9750TFX26A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR