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

Model Number 9600TFX29A

Device Problems Migration or Expulsion of Device (1395); Perivalvular Leak (1457)

Patient Problem Insufficient Information (4580)

Event Date 01/05/2023

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.Valve remains implanted.

Event Description

During thv in mac procedure using a 29mm sapien 3 valve via transfemoral approach, the patient had a severe paravalvular leak (pvl) and then the valve migrated.A second valve was implanted successfully with no pvl.Both valves remained in the annulus.

Manufacturer Narrative

The 29mm sapien valve was not returned 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.It should be noted that the thv was deployed in the native mitral position with severe mitral annular calcification (mac) using transfemoral approach.The sapien 3 (s3) thv with the commander delivery system (ds) is currently only indicated for valve replacement involving native aortic valve, a surgical or transcatheter bioprosthetic aortic valve, a surgical bioprosthetic mitral valve, or a native mitral valve with an annuloplasty ring.Therefore, this was an off-label operation.The ifu and training manuals in this section are for tf (transfemoral) procedure in the aortic/mitral position and were reviewed for relevant guidance for an s3 implant using a commander ds.The complaints for valve migration and paravalvular leak were unable to be confirmed due to the unavailability of relevant imagery and/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.As reported, "during thv in mac procedure using a 29mm sapien 3 valve via transfemoral approach, the patient had a severe paravalvular leak (pvl) and then the valve migrated.A second valve was implanted successfully with no pvl.Both valves remained in the annulus.The perceived root cause for this event was due to late migration atrial." per the instructions for use (ifu), valve migration requiring intervention is a known potential adverse event associated with transcatheter valve replacement (thv).According to the literature review, valve migration results when forces acting on the transcatheter heart valve (thv) overcome the strength of attachment of the valve to the annulus.Per the instructions for use (ifu), paravalvular leak (pvl) is a known potential adverse event associated with bioprosthetic heart valves and the transcatheter valve replacement (thv) procedure.In this case, atrial thv migration likely led to a compromised seal between the pvl skirt and the target site.The presence of severely calcified mitral annulus could have also promoted pvl-channels formation due to suboptimal overlap between the pvl skirt and target site.In this case, implanting the valve directly within mitral annular calcification (mac) could have rendered suboptimal anchoring forces for the thv due to irregular/bulky characteristics of the target site, causing the valve to migrate into the atrium.Available information suggests that procedural factors (off-label operation) 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 corrective or preventative actions are required.

• Brand Name: SAPIEN 3 TRANSCATHETER HEART 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: 16244841
• MDR Text Key: 308143573
• Report Number: 2015691-2023-10368
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)241030
• 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: 03/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• 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