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); Malposition of Device (2616); Device-Device Incompatibility (2919)

Patient Problem Insufficient Information (4580)

Event Date 01/08/2023

Event Type  Injury  

Manufacturer Narrative

Valve remains implanted.Investigation is ongoing.

Event Description

As reported by field clinical specialist, a patient that presented with severe pvl one month post implant of the 29mm sapien 3.The patient received a 29 ultra resilia valve, (b)(4) model number 9755rsl29a.Patient was done transfemorally with no procedural complications, mg of 3mmhg post valve and no pvl.The patient initially presented with severe ai and was not a surgical candidate, post 2x mvr.It is also noted that there is communication/connection from aortic structure to mitral valve- pvl jet that isn't mitral inflow or mitral regurgitation.Per proctor review, there is a biological valve in mitral position with post in the middle of the lvot.The post protruding in the center of lvot is at 7 mm from the annulus as sn showed in the original 3 mensio.When s3 29 was inserted (fully crimped) in the lvot made contact with the post.During s3 expansion the post entered the last strut of the s3 and held the strut.This created a top down foreshortening and tilted s3 after balloon deflation.The s3 was implanted 30/70 between lcc and ncc with intra/ extra pvl because there is no sealing on the anulus with the skirt.But more important the s3 is tilted away from the annulus from the post.

Manufacturer Narrative

Update to b4, b7, g3, g6, h2, h6 and h10 per no product returned evaluation.The device is not available for return and evaluation, as it remains implanted.Therefore, no visual inspection, functional testing, or dimensional testing could be performed.Imagery was reviewed by ew proctor.''the post protruding in the center of lvot is at 7 mm from the annulus.When the s3 29mm was inserted (fully crimped) in the lvot it made contact with the post.During s3 expansion, the post entered the last strut of the s3 and held the strut.This created a top down foreshortening and tilted the s3 after balloon deflation.S3 is implanted 30/70 between lcc and ncc with intra/extra pvl because there is no sealing on the annulus with the skirt.'' the reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.Therefore, no lot history review and no device history review are required.As no device was returned and there is no evidence to support a manufacturing/design defect potentially contributed to the complaint, a manufacturing mitigation review is not required.A complaint history review on confirmed device complaints (returned and no product returned) from (b)(6) 2022- (b)(6) 2023 for the sapien 3 valve (all models and sizes) was performed with the relevant codes identified.Prior closed complaints with any of the relevant codes were reviewed for similar events and root cause identification.Potential root cause applicable for this complaint event is procedural factors (malpositioned valve).It should be noted that in this case the thv was implanted to treat aortic insufficiency in a non-calcific native aortic annulus.The sapien 3 (s3) with the commander delivery system (ds) was indicated to treat native calcific aortic stenosis or failed aortic/mitral bioprosthesis with stenosis and/or regurgitation.Therefore, this case is considered off-label.The ifu and training manuals in this section are for transfemoral procedure in native aortic annulus with calcific stenosis and was reviewed for relevant guidance for a sapien 3 valve implant using a commander delivery system.The commander delivery system with s3/s3u/s3ur ifu, and procedural training manual were reviewed.It does note that ''patients with pre-existing prostheses should be carefully assessed prior to implantation of the valve to ensure proper valve positioning and deployment.'' no ifu/training deficiencies were identified.Implanting sapien 3 thv (s3) with the commander delivery system (ds) in a non-calcified aortic annulus is not an indicated for use.The review of the risk management file is complete, and no further action is required at this time.The malposition, interaction with pre-existing device, and paravalvular leak were confirmed based on imagery review.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of ifu/training materials revealed no deficiencies.It should be noted that the thv was implanted in a non-calcific native aortic annulus.The sapien 3 (s3) with the commander delivery system was treat native calcific aortic stenosis or failed aortic/mitral bioprosthesis with stenosis and/or regurgitation.Deployment in a non-calcific aortic annulus to treat aortic insufficiency is considered off-label.As reported, ''a patient presented with severe pvl with the 29mm sapien 3 (s3) less than one month post procedure.Patient initially presented with severe ai and not a surgical candidate, post 2x mvr''.Based on imagery review by proctor, a stent post from the pre-existing valve in mitral position was protruding through the middle of the lvot.When the crimped thv was inserted in the lvot, the thv contacted the post.During expansion, the post entered the last strut of the thv and held the strut in place, which created a foreshortening and tilted the thv after balloon deflation.The thv was implanted 30/70 (a/v) between lcc and ncc with intra/extra pvl because there is no sealing on the annulus with the skirt.Per imagery review, the crimped valve interacted with the stent post protruding through the lvot.As such, available information suggests that procedural factors (pre-existing mitral valve post protruding into lvot) may have contributed to the reported complaint event.In this case, interaction of the thv with the post of mitral valve, held the thv during valve deployment resulting in a 30/70 (aortic/ventricular) position.As such, available information suggests that procedural factors (interaction with pre-existing device) may have contributed to the complaint event.Due to thv malposition (too low deployment), it is likely that the pvl skirt was not sealed against the annulus resulting in paravalvular leak.As such, available information suggests that procedural factors (thv malposition) may have contributed to the complaint event.Since no device problem was identified affecting distributed product, no pra is required.Since no edwards defects were identified, no corrective or preventative actions are required.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.

• 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16258806
• MDR Text Key: 308309255
• Report Number: 2015691-2023-10422
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)241206
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX29A
• Device Catalogue Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Sex: Male