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

Model Number 9300TFX29A

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

Patient Problem Pulmonary Regurgitation (2023)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

The date of the event is unknown.According to the article all implants were completed between january 2014 and february 2018.For this reason, the first day of the range was used as the occurrence date.

Event Description

Per the article ¿sapien valve for percutaneous transcatheter pulmonary valve replacement without ¿pre-stenting¿: a multi-institutional experience¿, between january 2014 and february 2018 a total of 57 patients underwent percutaneous placement of the sapien (xt or s3) valve in the pulmonary position in native right ventricular outflow tracts (rvots) without the use of a prior stent (¿pre-stenting¿).In one case, after deployment of a 29mm sapien xt valve, the echocardiogram showed moderate to severe pulmonary regurgitation (pr) which persisted on the post-procedural echocardiogram.The patient was anticoagulated with 3 months of coumadin, but the 1 month and 2 month post-procedure echocardiograms continued to show moderate to severe pr.A sapien s3 valve was inserted within the xt valve 3 months later with no procedural difficulty and good results.The initial procedure took over 6 hours of procedural time to deliver the valve and required the valve to be remounted.The extensive manipulation and remounting was presumed to have trapped a leaflet in the stent struts.This valve was thought to have been damaged or distorted by the extensive manipulation and remounting required for its delivery.Reference: morgan gj, sadeghi s, salem mm, wilson n, kay j, rothman a, galindo a, martin mh, gray r, ross m, aboulhosn ja.Sapien valve for percutaneous transcatheter pulmonary valve replacement without ¿pre-stenting¿: a multi-institutional experience.Catheterization and cardiovascular interventions.2018 oct 23.

Manufacturer Narrative

This is one of three manufacturer reports being submitted for this article.Please reference related manufacturer report numbers: 2015691-2018-04854, 2015691-2018-04855, 2015691-2018-04856.Per the instructions for use (ifu), central leak is a potential risk associated with bioprosthetic heart valves and the transcatheter valve replacement 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 xt valve leaflets and cause pulmonic regurgitation.Occasionally there are cases where the root cause of the regurgitation cannot be determined.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.Per the ifu, thv leaflets mishandled or damaged during any part of the procedure will require replacement of the thv.In this case, the moderate-severe pulmonic regurgitation was likely caused by the extensive manipulation and remounting performed during the procedure.In the addition, the ifu cautions that to prevent possible leaflet damage, the thv should not remain fully crimped and/or in the loader for over 15 minutes.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.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8096460
• MDR Text Key: 128194169
• Report Number: 2015691-2018-04856
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9300TFX29A
• 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): Required Intervention