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

Model Number 9600TFX29A

Device Problems Fluid/Blood Leak (1250); Incomplete Coaptation (2507)

Patient Problem Injury (2348)

Event Date 11/17/2020

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).The investigation is underway.

Event Description

As reported by a field clinical specialist, a 29 mm sapien 3 valve was implanted in the mitral position via transfemoral approach in a pre-existing non-edwards surgical valve.Upon valve deployment central leak was noted in the sapien 3 valve with mild to moderate perivalvular leak (pvl) around the surgical valve.Significant central leak was observed on the echo and the physician stated it appeared that the sapien 3 leaflets were not coaptating.The decision was made to post dilate with a 30mm zmed balloon with no change in the central leak.Approximately two weeks later the sapien 3 valve was explanted due to severe central leak and pvl.Upon removal it appeared one of the leaflets was not functioning properly.The patient was in stable condition post procedure and a surgical valve was implanted.The cause of the reported event is unknown.

Manufacturer Narrative

Additional information and correction b5 correction the explant date was changed from two weeks post implant to two days post implant.H7 correction to the date of explantation.  the investigation remains ongoing.

Event Description

Per additional information received it was clarified the valve was explanted post op day 2.

Manufacturer Narrative

The 29 mm sapien 3 valve was returned in the jar with solution.Imagery provided by the site showed the valve placement was too atrial, the valve was not fully expanded, multiple pv leaks were observed between the s3 and the existing bioprothesis valve, and there was abnormal leaflet motion possibly related to the venturi effect with central mitral regurgitation.Visual inspection revealed the valve profile was distorted likely due to the device extraction, the leaflet was wrinkled and stiffened, one strut was exposed through the skirt, and one leaflet flared at the outflow edge.Due to the condition of the returned device no functional or dimensional testing was able to be performed.A device history records (dhr) review did not reveal any manufacturing related issues that would have contributed to the complaint.A review of the lot history revealed no other similar complaints.The instructions for use (ifu), device preparation and the training manual were reviewed for instructions or guidance for proper use of the device and no deficiencies were identified.During the manufacturing process, the valve is visually inspected and tested several times.During manufacturing, the valve frame component was 100% inspected.During the final inspection, the valve was 100% inspected by both manufacturing and quality.These inspections and tests during the manufacturing process support that it is unlikely that a non-conformance contributed to the reported complaint.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 complaint for valve regurgitation pv leak, valve regurgitation central leak, leaflet motion restricted- in patient, and valve placement too atrial were confirmed from imagery provided for evaluation.A review of the dhr, lot history, and complaint history did not provide any indication that a manufacturing non-conformance contributed to the complaint event.A review of manufacturing mitigations supports that proper inspections are in place to detect issues relating to the complaint.A review of the ifu and training manuals revealed no deficiencies.During the manufacturing process, all sapien 3 valves undergo multiple inspections for leaflet appearance/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.As reported, upon valve deployment central leak was noted in the sapien 3 valve with mild to moderate pv leak[?]the physician stated it appeared that the sapien leaflets were not coaptating.' per ifu, device malposition, paravalvular leak (pvl) and central regurgitation are potential adverse events associated with bioprosthetic heart valves and the transcatheter heart valve procedure.Paravalvular leak refers to blood flowing through a channel between the structure of the implanted s3 valve and the existing surgical mitral valve due to 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.Per training manual, the final s3 valve implant depth should be targeted no more than 20% (atrial) for optimal valve function.In addition, the thv requires to be fully expanded for proper function.The pre-existing st.Jude 33mm valve has inner diameter of 28.5mm which is the upper diameter for s3 29mm valve.To achieve a good deployment and sealing, it is recommended to deploy a 29mm s3 valve with extra volume in 10/90 (a/v) position.In this case, the initial deployment was performed using nominal volume (33ml).Based on the fluoroscopy images, the s3 valve was deployed too atrial (45/55, a/v) and the valve was under-expanded.As such, available information suggests that procedural factors (malposition of the valve and under-expansion of the valve) may have contributed to the pvl.Leaflet motion restricted-in patient and valve regurgitation-central leak too atrial deployment of a s3 valve in a mitral position can lead to leaflet overhang.As a result, the mitral leaflet deflected flow, creating a venturi effect where a reduction in blood pressure cause the s3 valve leaflet to not close properly and result in central mr.During product evaluation, it was noted that one of the leaflets had a fold mark and a flared outer edge.This observation aligned with the curvy leaflet seen in figure 4 and could be related to the venturi effect as described above.Similarly, under-expansion of a valve may restrict the leaflet motion, leading to abnormal coaptation and result in the same failure.In this case, the valve was post-dilated with a 30mm zmed balloon but without success.Procedural training manual lists central ar' as risks associated with post-dilation and instructs user not to post-dilate if regurgitation is central.Post-dilation may further disrupt the leaflet leading to central mr.As such, available information suggests that procedural factors (malposition of the valve/under-expansion of the valve/post-dilation) may have contributed to the reported event.This individual report provides data received from the thv/tvt registry.The complaint was confirmed.No manufacturing nonconformances were identified.No labeling/ifu/training inadequacies were identified.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.As such, neither a product risk assessment escalation, nor corrective or preventative actions are required.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10999306
• MDR Text Key: 221247058
• Report Number: 2015691-2020-15009
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: 9600TFX29A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2020
• Date Manufacturer Received: 03/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR