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

Model Number 9300TFX26

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem Aortic Regurgitation (1716)

Event Date 02/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is ongoing.

Event Description

As reported, during the transfemoral tavr procedure, a 26mm sapien 3 valve was deployed within an existing 26mm sapien xt valve in order to resolve the patient's central ai.Initially, it was thought that the patient had moderate pvl.During the procedure, the tee showed the anterior leaflet was not moving.The sapien xt valve had been initially deployed via tf approach, as intended, in a 80:20 aortic position, resulting in no pvl.The s3 valve was deployed 70:30 aortic.Repeat tee showed pvl graded at trivial-none.Patient is in stable condition.

Manufacturer Narrative

The investigation confirmed that the second valve was placed approximately one year post initial implant.Cine and pre-op ct images were provided and reviewed by an edwards physician proctor: viv angiography: original xt fully expanded.Sapien 3 valve implanted (viv) into xt with good position (b)(6) 2016 tte: poor imaging quality, unable to view valve leaflets well ct.Unable to visualize leaflets impressions: unable to confirm leaflet immobility due to poor imaging quality (unable to visualize leaflets).Sapien 3 viv implant in good position.Regurgitation- central worsening (post tavr, 30 days or >) per the instructions for use, valve regurgitation is a potential adverse event associated with bioprosthetic heart valves and the tavr procedure.Regurgitation which develops progressively over time can be due to a number of 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.In this case, investigation including review of imaging, was unable to confirm the event or any potential contributing factors.A complaint history for this type of event is 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 preventive actions are required.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 5471122
• MDR Text Key: 39414875
• Report Number: 2015691-2016-00616
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/05/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/03/2016
• Device Model Number: 9300TFX26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2016
• Initial Date FDA Received: 03/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2015
• 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: 83 YR
• Patient Weight: 101