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

Model Number 9600TFX26A

Device Problems Perivalvular Leak (1457); Incomplete Coaptation (2507); Defective Device (2588)

Patient Problems Mitral Regurgitation (1964); Injury (2348); No Code Available (3191)

Event Date 10/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The investigation is ongoing.

Event Description

After implant of a 26mm sapien 3 valve within a pre-existing non-edwards annuloplasty ring in the mitral position, the valve was post-dilated with a truballoon.After post-dilation, the leaflets were not working.A second 26mm sapien 3 valve was implanted with good results.

Manufacturer Narrative

The device was not available for evaluation as it remains implanted in the patient.Due to the device and/or relevant imagery/video not being returned for evaluation, visual, functional, or dimensional analysis could not be performed.The complaints for leaflet ¿ inadequate coaptation-in patient and valve ¿ regurgitation-pv leak were unable to be confirmed.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 unlikely that a manufacturing defect or device malfunction contributed to the events.The valve-in-valve patient screening and procedural training manual instructs the operator on proper sizing, positioning and deployment of the valve in surgical bioprosthesis, including all procedural and anatomical considerations.It should be noted that valve-in-valve procedural training manual is not currently indicated for s3 deployment in an annuloplasty ring.The ifu states ¿to maintain proper valve leaflet coaptation, do not overinflate the deployment balloon.¿ the complaint description states that the s3 valve was post dilated using a non-edwards balloon.Over expanding the valve with additional inflation volume could damage the leaflet, restricting the leaflet from proper coaptation.However, without the specific inflation volume used, the suggested root causes above could not be confirmed.Additionally, the ifu states ¿use the same balloon¿ during post dilation.In this case a non-edwards balloon was used to post dilate which may have damaged the leaflets.However, there is insufficient information to determine a definitive root cause at this time.Per ifu, paravalvular leak (pvl) is a potential adverse event associated with bioprosthetic heart valves.In this case, paravalvular leak refers to blood flowing through a channel between the structure of the implanted valve and the existing bioprosthesis surgical valve, as a result of a lack of appropriate sealing of the valve to the target site.Some pvl is not uncommon post deployment.Many cases are mild to moderate, and either resolve over time or do not cause symptoms.Others may be more clinically significant and require intervention.As reported, the sapien 3 valve was implanted within a pre-existing non-edwards annuloplasty ring in the mitral position.Annuloplasty rings can vary in both shape and rigidity that may result in lack of appropriate sealing of the valve at the target site.Using the s3 valve in a method in which it is not currently indicated may result in improper sealing at the target site.However, this cannot be confirmed without the procedural cine images returned for evaluation.The following manufacturing mitigations are in place at edwards lifesciences to ensure all sapien 3 valves meet the valve specification.During manufacturing, frame components underwent the following inspections: 100% dimensionally inspected; 100% visually inspected for scratches, fracture/cracks, rough surface, distortion, gap/void/notch, step, wavy cut, grinding, burrs and protrusions; 100% visually inspected for scratches, grooves, and deformation after cleaning and drying cycle.Skirt components underwent the following inspections: during receiving inspection, the number of yarns per inch of the base material used to fabricate of main skirt and pvl skirt is counted to ensure they meet the specification; the laser cut skirt components are 100% visually inspected for frays/breaks and yarn breaks and dimensionally inspected.Leaflet components underwent the following inspections: leaflet thickness was measured per process sheet/work order requirements; leaflets were 100% tested and grouped by deflection category for subsequent processes; die cut leaflets were dimensionally inspected on a sampling basis; die cut leaflets were visually inspected on sampling basis to verify tissue slit exist; die cut leaflets were 100% visually inspected for mechanical defects (e.G.Delamination, separation, damaged tissue surface, thin spot, and wrinkle).During manufacturing, all sapien 3 valves are 100% inspected for the following before and after placing the valve in holder: valve od and check for commissure tab tightness (resistance); visual inspect tissue for damage, tear, and crease that can prevents the leaflet from natural flexing; main skirt and pvl skirt to frame attachment for correct number of stitches, ensure each center of pvl upper edge is aligned with the upper junction of the frame strut, the main skirt is smooth, and enlarged or stretched holes.During the production flow testing, the coaptation test was performed.The adequacy of thv valve coaptation and valve appearance are 100% inspected before and after valve holder attachment.Prior to final packaging, 100% visual inspection is performed to ensure no damage to the valve from handling.These manufacturing inspections support that it is unlikely that a manufacturing non-conformance contributed to the reported complaint.Review of device history record (dhr) did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.A lot history review revealed no other similar related complaint.A review of complaint history revealed that the occurrence rate did not exceed the (b)(6) 2018 control limit for the applicable trend categories.Due to the device and/or relevant imagery/video not being returned for evaluation, the complaints for leaflet ¿ inadequate coaptation-in patient and valve ¿ regurgitation-central leak were unable to be confirmed.No manufacturing non-conformances were identified during evaluation.There is insufficient information to determine the definitive root cause at this time.Since no labeling or ifu/training inadequacies were identified and review of the complaint history revealed that the occurrence rate for the applicable trend categories did not exceed their (b)(6) 2018 control limits, neither a product risk assessment (pra), nor corrective or preventative action is required at this time.

Manufacturer Narrative

The valve was post-dilates due to paravalvular mitral regurgitation.After the valve in valve was performed, paravalvular mitral regurgitation was still observed, requiring plugs.The patient was stable post procedure.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER, 26MM
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8022272
• MDR Text Key: 125590805
• Report Number: 2015691-2018-04458
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2020
• Device Model Number: 9600TFX26A
• 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: 53 YR