MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER, 29MM; MITRAL VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX29A

Device Problems Perivalvular Leak (1457); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  Injury  

Event Description

As reported by edwards field clinical specialist (fcs), after implant of a sapien 3 valve in the native mitral annulus by transspetal approach, the valve migrated and paravalvular leak was noted.The mitral annulus was calcified, and the annulus was measuring large.The 1st valve did not fully anchor and began to migrate due to the large annulus.At the time mild paravalvular leak (pvl) was noted.The valve migrated and pvl worsened.A 2nd 29mm sapien 3 valve was implanted to secure the 1st valve.The pvl was mild.The patient was stable.

Manufacturer Narrative

The investigation is ongoing.The valve remains implanted in the patient.

Manufacturer Narrative

Update to h6 (type of investigation, investigation findings, investigation conclusions), and h10 to reflect device evaluation.The 29mm sapien 3 valve was not returned to edwards lifesciences for evaluation as it remains implanted in the patient.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.The commander delivery system with s3/s3u if and procedural training manual was reviewed for guidance and instructions.The procedural training manual provides guidance on thv deployment.Check to ensure that the thv is exactly between the valve alignment markers, flex tip is on the triple marker and the balloon lock is locked.Perform thv deployment by unlocking the inflation device, initiate rapid pacing ensuring 1:1 capture, sbp less or equal 50 mmhg, and pulse pressure <10 mmhg, confirm placement of center marker within optimal initial center marker zone, begin initial deployment with a slow controlled inflation, fully inflate and hold for 3 seconds to ensure complete deployment, completely deflate and stop pacing and withdraw the balloon from the native valve.Additional considerations are to verify flex tip is on triple marker to, ensure full inflation of balloon during deployment and ensure stability of delivery system during thv deployment.Slow inflation during initial deployment may help with stability of the delivery system and thv during deployment.If considered, reposition only at the very early stage of deployment, do not exceed 20 seconds for inflation and deflation of the delivery system, always maintain control of the plunger of inflation device when releasing it and never lock the inflation device during bav or thv deployment.A slow controlled inflation during initial deployment may help with stability of the delivery system and thv.Factors that may affect the thv deployment characteristics are narrow, calcified stj: thv movement ventricular and/or reduced foreshortening of the thv and incomplete thv expansion: reduced foreshortening of the thv.The delivery system requires a prescribed volume for thv deployment and proper function.In addition, the procedural training manual provides guidance on assessing aortic regurgitation, paravalvular leak.Small paravalvular regurgitant jets are common, they are hemodynamically insignificant, and they may resolve within minutes to hours.There was no ifu or training deficiencies identified.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 complaints for thv migrated and deployed valve exhibits paravalvular leak were unable to be confirmed due to unavailability of relevant imagery or medical record.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 this was an off-label operation as the thv was implanted in native mitral annulus.The sapien 3 thv (s3) with the commander delivery system (ds) is currently indicated for native aortic valve, surgical or transcatheter bioprosthetic aortic valve, a surgical bioprosthetic mitral valve, or a native mitral valve with an annuloplasty ring replacement.As the valve migrated with off label operation, it could cause the inadequate seal between the valve and native annulus resulting in paravalvular leak as reported.As reported, 'after implant of a sapien 3 valve in a native mitral annulus by transspetal approach, the valve migrated and paravalvular leak was noted.The mitral annulus was calcified and measuring large, and the 1st valve did not fully anchor and began to migrate due to the large annulus.At that time mild paravalvular leak (pvl) was noted.' per the instructions for use (ifu), valve migration is a known potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement (tvr) procedure.Since the patient had a larger mitral annulus compared to the size 29mm thv and noted that not sure about exact annular measurement but i think it was in the upper end of the 29mm s3 range'.And the second valve was successfully deployed with additional five (5) cc.In this case, the valve could be initially under expanded, which led to the thv migration after deployment.In additional, it could challenge to deployed valve into the native mitral annulus (off label operation).In this case, available information suggests that patient factors (large native mitral annulus) and/or procedural factors (valve under deployment, off label operation - thv migration) may have contributed to the complaint event.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.No labeling or ifu training inadequacies were identified.Therefore, no corrective or preventive actions nor product risk assessment are required.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER, 29MM
• Type of Device: MITRAL 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: 15271855
• MDR Text Key: 298379357
• Report Number: 2015691-2022-07455
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)241216
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 10/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2021
• 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 Sex: Female