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

Model Number 9300TFX23A

Device Problem Device-Device Incompatibility (2919)

Patient Problem Aortic Regurgitation (1716)

Event Date 01/08/2015

Event Type  Injury  

Event Description

Post valve deployment, the inflow portion of a 23mm sapien xt valve was not fully expanded.Multiple post dilations of the valve were performed, resulting in significant central aortic insufficiency (cai).A second valve was deployed to correct the cai.During the transfemoral tavr procedure, balloon aortic valvuloplasty was performed with a 20mm x 4cm edwards balloon.No complications or issues were noted.A 23mm xt valve was prepared using normal preparation technique and advanced into position.The valve was deployed in a final 50:50 aortic/ventricular (a/v) position, resulting in no paravalvular leak (pvl) and no cai; however, a mean gradient of 26mmhg was noted.It was observed that the inflow portion of the valve was not fully expanded.Post dilation was performed using a 20mm x 4cm non-edwards balloon and the mean gradient was reduced to 20mmhg, with no pvl and no cai.A second post dilation was performed with a 22mm x 4cm non-edwards balloon, resulting in no change to the mean gradient, pvl or cai.A third post dilation was performed using a 24mm x 4cm non-edwards balloon.The mean gradient was reduced to 15mmhg; however, there was now significant cai.A second 23mm xt valve was prepared with 2cc additional volume and deployed in a 40:60 a/v position.The valve visually looked much better; however, the mean gradient was 25mmhg.Post dilation of the second valve was performed with 2cc additional volume (total of 21cc), reducing the mean gradient to 13mmhg with no pvl and trace cai noted.The procedure was completed.The patient was extubated in the room and transferred in stable condition.It was perceived that due to the patient¿s pre-existing homograft and narrowing of the lvot, starting in a more ventricular position would have been best.The patient¿s native annulus measured 18mm x 22mm by ct (valve area 410mm2).Annular calcification, native leaflet calcification and aortic root calcification were reported as moderate.The patient¿s sinotubular junction (stj) measured 28mm with moderate calcification noted.

Manufacturer Narrative

Per the instructions for use, valve 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 valve 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 xt 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 xt 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, procedural factors (multiple post dilations of initial valve), in addition to patient factors (pre-existing homograft) likely caused this event.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 VALVE
• 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: deborah deutsch ; 1 edwards way; irvine, CA 92614 ; 9497564213
• MDR Report Key: 4437778
• MDR Text Key: 5314542
• Report Number: 2015691-2015-00134
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2015
• Device Model Number: 9300TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2015
• Date Device Manufactured: 07/10/2014
• 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: 57 YR
• Patient Weight: 111