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

Model Number 9300TFX23

Device Problems Inflation Problem (1310); Migration or Expulsion of Device (1395); Device-Device Incompatibility (2919)

Patient Problem Aortic Valve Stenosis (1717)

Event Date 05/06/2015

Event Type  Injury  

Event Description

As reported by our european affiliate, during a transfemoral tavr procedure, a 23mm sapien xt valve was placed in an existing bioprosthetic aortic valve.Following post dilation, the xt valve embolized into the ventricle.The xt valve was explanted and a surgical valve was implanted.During the procedure, the xt valve was positioned inside the existing bioprosthetic valve; however, the xt valve could not be fully expanded, limiting the xt leaflet movement, due to the severe calcification of two leaflets of the existing valve.A balloon aortic valvuloplasty (bav) was performed with 1ml addition volume, allowing the xt valve to open a little bit more; however, at this point, the xt valve embolized into the ventricle.The novaflex+ (nf+) delivery system (ds) was removed and the guidewire was left in place to maintain the xt valve.The procedure was converted to open surgery and the xt valve was explanted.The existing bioprosthetic valve was also explanted.A surgical valve was implanted.At the time of this report, the patient was doing well.It was perceived that the completely calcified leaflets of the existing bioprosthetic valve contributed to the under expansion and subsequent embolization of the xt valve.

Manufacturer Narrative

Per the instructions for use (ifu), device embolization is a known potential complication associated with the transcatheter aortic valve replacement (tavr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to ventricular embolization, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, a narrow, calcified sinotubular junction, minimally calcified aortic leaflets, and loss of pacing capture.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the sapien xt 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 patients with high-risk anatomical features for ventricular embolization (i.E.Small, calcified stj, minimal leaflet calcification), bav may provide indication of potential balloon movement during valve deployment.In this case, severe calcification of the pre-existing bioprosthetic aortic valve prohibited the sapien xt leaflets from opening freely.Both valves were explanted and a new surgical valve was placed.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: 4808872
• MDR Text Key: 5915613
• Report Number: 2015691-2015-01256
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9300TFX23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/06/2015
• 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