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

Model Number 9600TFX29

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Incomplete Coaptation (2507)

Patient Problem Mitral Regurgitation (1964)

Event Date 07/02/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is ongoing.

Event Description

As reported to implant patient registry (ipr), two valves were placed in the mitral position.The first 29mm sapien 3 valve was placed in the mitral annular calcification (mac).A second valve was placed due to wide open mitral regurgitation, from what looked like a leaflet was being held open.It is unknown what was causing the immobile leaflet.The second valve was placed successfully.

Manufacturer Narrative

The additional information pertaining to the complaint evaluation indicated this is an off-label case (valve in mac).It was reported that all devices and wire were no longer across the valve when it looked like a leaflet was being held open.Pre-op ct and echo imagery were provided and are evaluated.Edwards commander delivery system was used to deploy the valve.As the affected device was not returned, the investigation was limited to review of photographs, video, or imagery, review of device history records (dhr), review of lot history, review of complaint database for similar complaints, review of physician training and ifu materials, manufacturing mitigations, root cause analysis, and fmea assessment.A review of returned imagery did not reveal any relevant information pertaining to the complaint evaluation.The pre-op ct only captured aortic valve information, not mitral valve, and the echo was recorded on post-operative day 1 (after valve-in-valve), therefore images of the first implant were not available.A dhr review of the orders related to the manufacturing of the devices and components that could potentially contribute to the complaint was performed.The work orders did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.A lot history review did not reveal any other additional complaint for the related work order.A review of complaint history for sapien 3 (all sizes) from august 2017 to july 2018 revealed other device returned similar complaints.These complaints were unable to be confirmed, and no manufacturing non-conformance were identified during engineering evaluation.Although a definite root cause was unable to be determined, based on given information, procedural factors (under expansion valve, over-inflation of deployment balloon and leaflet damage due to post dilatation) may have contributed to the reported events.A review of complaint history revealed that the occurrence rates did not exceed the july 2018 control limits for the applicable trend categories.It should be noted that the first thv was deployed in the native mitral valve.The sapien 3 (s3) with the commander delivery system (ds) is currently indicated for native aortic valve replacement and surgical bioprosthetic aortic or mitral valve replacement.The ifu and training manuals in this section are for a tf procedure in the aortic position or in a surgical bioprosthetic mitral valve and were reviewed for relevant guidance for an s3 implant using a commander ds.No ifu/training deficiencies were identified.The multiple manufacturing mitigations are in place at edwards lifesciences to ensure all sapien 3 valves meet the valve specification.Frame components were 100% visually inspected by both manufacturing and quality for scratches, fracture/cracks, rough surface, distortion, gap/void/notch, step, wavy cut, grinding, burrs and protrusions.Frame components are also 100% dimensionally inspected.Frame components are also 100% visually inspected by manufacturing for scrathes, grooves, and deformation using 10x magnification after cleaning and drying cycle.Leaflet components underwent multiple inspections.Leaflet thickness was measured per process sheet/ work order requirements.Leaflets were 100% tested and grouped by deflection category for subsequence process.Die cut leaflets are dimensionally inspected on sampling basis and were visually inspected on sampling basis to verify tissue slit exist under 8x magnification, and 100% visually inspected for mechanical defects (e.G.Delamination, separation, damaged tissue surface, thin spot, and wrinkle).During the production flow testing, the coaptation test was performed using appropriate fixtures and instructions.The adequacy of thv valve coaptation and valve appearance were 100% inspected before and after valve holder attachment.Prior to final packaging, 100% visual inspection was performed at preliminary packaging to ensure no damage to the valve from handling.These manufacturing inspections support that it is unlikely that a manufacturing nonconformance contributed to the reported complaint.Due to no images of the first implant being provided for evaluation, the complaints of leaflet motion restriction-in patient and valve central leak were unable to be confirmed.  a review of the dhr, lot history, and complaint history revealed no indication that a manufacturing non-conformance contributed to the complaint.During the manufacturing process, all sapien 3 valves are 100% visually inspected for defects and 100% tested for proper coaptation under physiological backpressure conditions prior to release for distribution.Therefore, it is highly unlikely that a manufacturing defect or device malfunction contributed to the event.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.There are several potential patient and procedural factors that alone or in combination can cause or contribute to a report of a restricted or nonfunctioning leaflet.Based on historical review of complaints, these events are typically a result of incorrect valve size, improper valve expansion, native leaflet overhang due to valve deployment too atrial, leaflet impingement in a calcified valve or slow recovery of adequate ventricular flow post valve deployment and rapid pacing.This can result in a temporary decrease in the pressure gradient between the left ventricle and the left atrium, resulting in an inadequate pressure change to close the leaflets.In many instances this can be overcome with troubleshooting, which includes blood pressure recovery or support.Per the ifu, central regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter heart valve replacement procedure.Additional, the safety and effectiveness of the device for patients with severe mitral annular calcification (mac) or severe (> 3+) mitral insufficiency have not been established.The aforementioned patient and/or procedural factors can all contribute to suboptimal coaptation of the sapien 3 valve leaflets and cause central regurgitation.However, there is insufficient information to determine a root cause at this time.Since no manufacturing non-conformances or labeling/ifu/training deficiencies were identified, no corrective/ preventative actions are required.Additionally, since no product non-conformance was confirmed and the occurrence rate did not exceed the applicable complaint trending control limits, a product risk assessment (pra) escalation is not required.

Manufacturer Narrative

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: 7707045
• MDR Text Key: 114606687
• Report Number: 2015691-2018-02956
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2019
• Device Model Number: 9600TFX29
• 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
• Patient Age: 73 YR