MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN XT TRANSCATHETER HEART VLV; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9300TFX23

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aortic Regurgitation (1716)

Event Date 07/26/2016

Event Type  Injury  

Manufacturer Narrative

Investigation of this event is ongoing.

Event Description

As reported by the edwards (b)(4) affiliate, sapien xt valve was deployed with nominal volume and in optimal position.Once the delivery system was pulled back an aortogram/root shot was taken to assess the valve, which revealed a posterior paravalvular leak.Post-dilation with an added 2cc of volume was completed.Another aortogram was taken to assess the valve and now showed central ai.Fluoro revealed a leaflet that seemed to have prolapsed.A second 23mm sapien xt valve was deployed successfully, in optimal position and good result.The patient is stable and doing well.There were no adverse events to the patient.

Manufacturer Narrative

Images were provided to edwards for review.The images were reviewed by an edwards physician, and the following observations and impressions were provided: pre-op ct downloaded into 3mensio program for measurements.Aortic valve area from 3mensio measured 430cm2 compared to cer provided area of 370cm2.Recommend a 26mm sapien xt with a soft fill rather than 23mm.Cine images show a heavily calcified annulus.Good bav with contrast leak around balloon.Good implantation of the 1st valve.From looking at the stent struts, the valve appears fully expanded.Reported posterior pvl not seen, as procedural cine image and echo of valve after deployment was not provided.Post-dilation seen with full expansion of entire valve.Per physician training, post-dilatation of tavr should be expanded more ventricular to prevent damage to leaflets.Valve appears over-expanded after post-dilatation.Severe central ai now seen on cine.No ¿flailed leaflet¿ seen as reported, however, procedural tee echo not provided.Second (2nd) valve deployed into 1st valve.Per physician training, 1st valve should be more squared on cine (not 2nd undeployed valve) when doing a viv procedure.Mild ¿moderate pvl seen post viv.Echo cd provided is tte post-op day 1 and shows two eccentric pvl jets; degree of pvl is now mild.Per the instructions for use, central regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter aortic valve replacement (tavr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to central regurgitation including malposition of the valve, impingement of a leaflet due to the guide wire, over inflation of the deployment balloon, post dilation of the implanted valve, and slow recovery of adequate ventricular flow post valve deployment and rapid pacing.All of these factors have the potential to contribute to suboptimal coaptation of the sapien valve leaflets and cause central aortic insufficiency.Occasionally there are cases where the root cause of the regurgitation cannot be determined.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.The patient screening manual instructs the operator on proper native valve leaflet assessment, taking into consideration the length, bulkiness and distribution of calcium on the native leaflets to determine whether valve performance will be impaired.During the manufacturing process, all sapien valves are 100% visually inspected for defects and 100% tested for coaptation prior to release for distribution.This makes it highly unlikely that a manufacturing defect or device malfunction would contribute to the event.In this case, the central regurgitation was most likely caused by possible prosthetic patient mismatch with overexpansion of the valve post dilation.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.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VLV
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: frances preston, rn ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 5889300
• MDR Text Key: 52531514
• Report Number: 2015691-2016-02557
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 07/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2017
• Device Model Number: 9300TFX23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2016
• Initial Date FDA Received: 08/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2015
• 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: 92 YR