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

Model Number 9000TFX26

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/26/2014

Event Type  Injury  

Event Description

During a transfemoral tavr procedure the 26mm sapien valve was positioned 50/50 however it ended up deployed in a 70/30 aortic/ventricular position.A moderate paravalvular leak (pvl), with a very pronounced jet, was noted.The surgical team elected to post dilate the valve; however the pvl did not resolve.They felt that the valve was too aortic and did not get a good seal as the patient had very large sinuses and that a second valve placed more ventricular would resolve the issue.A second 26mm sapien valve was prepared and inserted, and as the valve began crossing the first sapien valve, resistance was encountered due to significant wire bias.They pushed harder on the delivery catheter, which caused the implanted sapien valve to embolize into the ventricle.At this point the decision was made to convert the patient to open surgery and do a savr, and retrieve the thv in the ventricle.The second sapien valve was pulled back into the sheath, where it remained until the end of the procedure.The first valve was retrieved from the ventricle, the savr was successfully completed and the sheath and second thv were removed with no complications in the heart or vasculature.The patient was doing well the following day.The native valve/leaflet calcification and the aortic root calcification were moderate.The native annulus diameter was 23mm by tee, and 22.4x 29.2mm by ct, with an area of 502².The sinus of valsalva diameter was reported to be large, with a measurement of 38.9mm.

Manufacturer Narrative

Per the instructions for use, device malposition requiring intervention is a known potential adverse event 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 aortic malposition, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, severe septal hypertrophy, minimally or severely calcified aortic leaflets, preserved ejection fraction, significant mitral annular calcification (mac), loss of pacing capture, and movement of the delivery system by the operator.Deployment of the sapien valve too aortic has the potential to contribute to suboptimal coaptation of the sapien valve leaflets and cause central aortic insufficiency; it can obstruct the coronary ostia; and lead to embolization of the prosthesis into the ascending aorta.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 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 aortic malposition (i.E.Minimal leaflet calcification, severe septal hypertrophy), bav may provide indication of potential balloon movement during valve deployment in this case, the exact cause of the aortic malposition could not be confirmed; however patient factors (borderline annulus size) and procedural factors (poor image intensifier angle) could have caused or contributed to the too aortic deployment of the valve and resulting pvl.As reported, the cause of the embolized valve was the delivery system catheter pushing on the implanted valve during advancement of the second valve.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: SAPIEN 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: 3759365
• MDR Text Key: 4469124
• Report Number: 2015691-2014-00904
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/26/2014

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: 10/21/2014
• Device Model Number: 9000TFX26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/26/2014
• Initial Date FDA Received: 04/18/2014
• Date Device Manufactured: 03/07/2013
• 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: 93 YR
• Patient Weight: 91