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

Model Number 9600TFX29A

Device Problem Migration (4003)

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

Event Date 02/01/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.A supplemental report will be submitted.This is one of two manufacturer reports being submitted for this case.Please reference related manufacturer report no: 2015691-2023-11022.Device remained implanted.

Event Description

Edwards received notification from a field clinical specialist of a transfemoral tmvr in a previously implanted in a non-edwards surgical valve.As reported, as the team began pacing in preparation for deploying the 1st valve across the mitral valve, the surgeon pushed the stiff wire forward to try and stand the 29 mm sapien 3 valve up.There was no difficulty inserting/advancing the delivery system through the sheath.There was no difficulty with valve alignment.When forward tension was placed on the wire the balloon catheter of the valve slid forward.During deployment the balloon fully expanded the outflow but did not in the inflow.The team worried about whether the valve was secure so they collapsed the balloon catheter and retracted it so that the distal dot was aligned with the outflow frame.Then the team post dilated while pacing.During the post dilation the first valve slipped ventricularly so that the big cells were now in the lvot and the inflow was not near the base of the 31m.The team then had to deploy a second valve across the surgical valve.

Manufacturer Narrative

The device was not returned for evaluation as it remained implanted.Therefore, a no product return engineering evaluation was performed.A review of provided imagery was performed and the following was observed: before post dilation, the inflow side of valve was not fully expanded.During post dilation, upon reaching full inflation, the balloon jumped forward, resulting in valve shifted ventricularly away from the sternum wire.After post dilation, the inflow side appears to be fully expanded.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 valve migrated was confirmed from imagery.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.Therefore, no device history record or lot history are required.A review of the ifu a nd training manuals revealed no deficiencies.As reported, ''as the team began pacing in preparation for deploying the 1st valve across the mv, the surgeon pushed the stiff wire forward to try and stand the 29 mm s3 valve up.When forward tension was placed on the wire the balloon catheter of the valve slid forward.During deployment the balloon fully expanded the outflow but did not in the inflow.The team worried about whether the valve was secure so collapsed the balloon catheter and retracted it so that the distal dot was aligned with the outflow frame.Then the team post dilated while pacing.During the post dilation the first valve slipped ventricularly so that the big cells were now in the lvot and the inflow was not near the base of the 31mm''.Per the instructions for use (ifu), valve migration requiring intervention is a known potential adverse event associated with transcatheter valve replacement (thv).In this case, a 29mm thv was implanted in a non-edwards surgical valve.As seen from imagery under fluoroscopy, during post dilation upon reaching full inflation, the balloon jumped forward, resulting in valve shifted ventricularly.As such, available information suggests that procedural factors (balloon movement during post-dilation) may have contributed to the reported event.No device or labeling problem was identified during the evaluation.Therefore, no further escalation (capa/scar/pra ) is required.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.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEATH VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, 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: 16428787
• MDR Text Key: 310077459
• Report Number: 2015691-2023-11023
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)251002
• 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: 04/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2023
• 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: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• 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: Male