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

Model Number 9600TFX

Device Problem Insufficient Information (3190)

Patient Problem Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

This report provides data from thv/tvt registry exemption number e2016006 and summarizes 3 reintervention - mitral valve serious injury events for the sapien 3 transcatheter heart valve in the mitral position.The ''time to event'' (tte, in days) for this event was 85.0.The device identification (di) numbers for edwards sapien 3 transcatheter heart valve are: (b)(6).Mitral valve re-intervention in the follow-up period (in the absence of prosthetic cardiac valve thrombosis) will typically result from on-going or worsening regurgitation, valve degeneration related to the formation of calcification or pannus, or valve migration.These events are identified in the product instructions for use (ifu) as potential risks associated with the use of the thv.Regurgitation which develops progressively over time can be due to several issues including patient related factors or structural valve deterioration, including calcification, non-calcific degeneration, leaflet thickening or fibrosis, or a combination of these.Regurgitation may also develop progressively if host fibrotic tissue, or pannus, grows onto the bioprosthetic valve.Pannus, a cause of nonstructural dysfunction, may interfere with functionality of the device by restricting the leaflet motion leading to abnormal coaptation.Calcification is a well-recognized failure mode of bioprosthetic valves.The mechanism of calcification of biomaterials is not completely understood but is probably related to an inability of the non-viable cells to maintain their normally low intracellular concentration of calcium.Another potential condition that may lead to re-intervention is patient prosthesis mismatch and/or under-expanded valves due to thv restriction from the existing valve frame.Incorrect bioprosthetic valve sizing, and incomplete frame expansion, can contribute to valve migration.In this case, there was no allegation or indication a product malfunction contributed to this adverse event.Specific clinical and procedural details are not available to determine potential contributing factors to the event, or if the event is related to an edwards 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.No corrective or preventative actions are required.Summary reported.

Event Description

Thv/tvt registry summary reporting for adverse event submission for quarter 2 2022 data extract for mitral serious injury events for the sapien 3 valve.This report summarizes 3 reintervention - mitral valve serious injury events for the sapien 3 transcatheter heart valve.The age range for this event is 70-73 years.The breakdown for gender is as follows: 1 female and 2 males.

Manufacturer Narrative

Correction to the exemption number field per fda request on 07/07/2022.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 14892718
• MDR Text Key: 295229132
• Report Number: 2015691-2022-06584
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• Exemption Number: 2016006
• Number of Events Reported: 3
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9600TFX
• 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: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 72 YR