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

Model Number 9600TFX29A

Device Problems Perivalvular Leak (1457); Incomplete Coaptation (2507); Failure to Align (2522); Positioning Problem (3009); Appropriate Term/Code Not Available (3191)

Patient Problem Tricuspid Regurgitation (2112)

Event Date 06/05/2020

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2020-12293.Investigation is ongoing.

Event Description

As reported, during a tf thv valve within a tricuspid ring case, three 29mm sapien 3 valves were used.The first valve (sn (b)(4)), implanted with an additional 5cc, was deployed with an "imperfect position".The valve was not seated properly into the surgical ring, and appeared to be canted.A second valve (sn 7155017) was implanted within the first with an additional 10cc, but lacked proper leaflet coaptation and exhibited central ai.One of the valve leaflets was noticeably ¿frozen¿ or not moving efficiently.A third valve (sn (b)(4)) was implanted with an additional 6cc, which rectified the leaflet coaptation issue but a plug was still needed for pvl around the surgical ring.Per the records received, the annuloplasty ring was not well aligned within the native tricuspid valve and the fist valve was therefore implanted more atrial than ideal.The decision was made to flare the ventricular side of the first valve by post-dilating it with +8cc before implanting the second valve more ventricular.After the second valve was placed, one of the leaflets of this new valve appeared to be "malfunctioning and not moving", resulting in moderate to severe transvalvular tricuspid regurgitation.The third valve was placed slightly more ventricular than the second valve with +10cc.There was evidence of paravalvular leak around the transcatheter valves, lateral to it, and the ring.The decision was made to fix the pvl, which was plugged.

Manufacturer Narrative

Reference (b)(4).

Manufacturer Narrative

The device remains implanted and was not returned for evaluation.Additionally, no relevant photograph/video/imagery was provided with the complaint.During manufacturing of the sapien 3 transcatheter heart valve, the valve and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.A dhr review was performed and did not reveal any manufacturing non-conformance issues that would have contributed to the complaint event.Additionally, a lot history review is not requested as the complaints related to the valve were unable to be confirmed.The events were unable to be confirmed, and the occurrence rate did not exceed the june 2020 control limits for applicable trend categories.Therefore, a complaint history review is not required.It should be noted that the thv was deployed in the tricuspid position.The sapien 3with the commander delivery system is currently indicated for native aortic valve replacement and surgical bioprosthetic aortic or mitral valve replacement.The ifu and training manuals were reviewed for a transfemoral procedure in the aortic position for relevant guidance for an s3 implant using a commander ds.The ifu notes that in patients with pre-existing bioprosthesis, care should be taken when assessing prior to the implantation of the valve to ensure proper valve positioning and deployment.Valve regurgitation is listed as a potential risk associated with transcatheter heart valve procedures.The reported event is an anticipated risk of the transcatheter heart valve procedure.A review of the risk management documentation (r8.11) for over expanded thv was performed.Potential hazard/harms severity classification is 3 and includes: additional information.In this case, an additional valve was implanted.The complaints were unable to be confirmed.Due to the unavailability of the device and/or relevant imagery, engineering was unable to perform any visual, functional, or dimensional analysis.A review of the dhr and manufacturing mitigations revealed no indication that a manufacturing non-conformance contributed to the complaint.Additionally, a review of the ifu and training manual revealed no deficiencies.It should be noted that the thv was deployed in the tricuspid position.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 for relevant guidance for an s3 implant using a commander ds.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.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.In this case, a second valve was implanted within the first valve with additional 10cc, and post implantation, due to an immobile leaflet, a moderate to severe transvalvular tricuspid regurgitation was seen.Per ifu, ¿to maintain proper valve leaflet coaptation, do not overinflate the deployment balloon¿.Overinflate the deployment balloon can potentially over expand the valve and damage the leaflets, preventing the valve from proper coaptation and lead to central regurgitation.As such, available information suggests that procedural factors (over inflation of the deployment balloon) may have contributed to the complaint events.However, a definitive root cause was unable to be determined at this time.No product non-conformance was identified, and the occurrence rate did not exceed the trend category control limit, therefore a product risk assessment is not required.No manufacturing non-conformances or ifu deficiencies were identified, corrective action is not required.

• 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: 10201184
• MDR Text Key: 199095545
• Report Number: 2015691-2020-12294
• 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,Followup
• Report Date: 06/05/2020

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: 11/09/2021
• Device Model Number: 9600TFX29A
• Device Lot Number: 7155017
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/05/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 07/23/2020; 07/23/2020
• Supplement Dates FDA Received: 07/28/2020; 12/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR