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

Model Number 9750TFX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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 1 reintervention - mitral valve event for the sapien 3 ultra transcatheter heart valve in the mitral position.The ''time to event'' (tte, in days) for this event was 156.The device identification (di) numbers for edwards sapien 3 ultra transcatheter heart valve are: (b)(6).Intra-procedural and in hospital mitral valve re-intervention will typically result from valve malposition or regurgitation (pvl or central, including leaflet restriction).These conditions are known potential risks associated with the use of the thv, delivery system, and/or accessories.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, characteristics of the pre-existing valve or ring, loss of pacing capture, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.Valve malposition has the potential to contribute to suboptimal coaptation of the thv valve leaflets and cause central aortic insufficiency; it can lead to migration or embolization of the prosthesis.Physicians are extensively trained by edwards before they are qualified to use the thv.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor to the placement and fixation of the device.Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment.In this case, specific procedural details are not available to determine potential contributing factors.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.No corrective or preventative actions are required.H3 other text : summary report.

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 ultra valve.This report summarizes 1 reintervention - mitral valve event for the sapien 3 ultra transcatheter heart valve.

Manufacturer Narrative

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

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 14894483
• MDR Text Key: 295229420
• Report Number: 2015691-2022-06596
• 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: 1
• 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: 9750TFX
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Female