MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX26A

Device Problems Fluid/Blood Leak (1250); Fracture (1260); Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Regurgitation (1716); No Known Impact Or Consequence To Patient (2692)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).Per the instructions for use (ifu), central regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) 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 aortic 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 information provided indicates the central regurgitation occurred as a result of post-dilation of the 26mm sapien 3 valve within the pre-existing non-edwards surgical valve.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.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.

Event Description

As reported, during a tf viv tavr case (s3 within a pre-existing 23mm non-edwards surgical valve) the physician needed to implant a second 26mm s3 valve within the first.Additional information was received.The first 26mm sapien 3 valve (sn (b)(4)) was implanted with the commander delivery system and was used to fracture the pre-existing surgical valve.The physician felt the thv valve wasn't fully expanded and decided to post-dilate the valve with nominal volume, resulting in moderate ai.The decision was made to implant the second 26mm s3 valve (sn (b)(4)) which resolved the ai.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 9772162
• MDR Text Key: 190975707
• Report Number: 2015691-2020-10778
• Device Sequence Number: 1
• Product Code: NPT
• 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,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/06/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2021
• Device Model Number: 9600TFX26A
• Device Lot Number: 7164807
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention