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

Model Number 9000TFX23A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Aortic Insufficiency (1715)

Event Date 01/21/2014

Event Type  Injury  

Event Description

The report represents the second valve.Per the field clinical specialist (fcs) report, this was a transfemoral tavr case.Pre deployment the 23mm sapien valve position was 60:40, but the patient¿s anatomy (severe annular calcification) caused the valve to move aortic during deployment and the valve end up too aortic (95:5 aortic).There was moderate-severe paravalvular leak (pvl).A 2nd 23mm sapien valve was implanted with good results in a 50:50 position with respect of the native annulus and no leak.According to the information provided, the native aortic annulus area measured 393mm2 by ct with severe calcification.The patient baseline ejection fraction was normal.After removing the sheath the physician proceeded to close the access site, but the device closure (proglide) failed and the area was ballooned.Then it was noticed a little dissection on the right common femoral artery (rcfa), caused by either the closure device or the balloon used.The patient was stable at the end of the procedure.The patient was reported to be doing well after the procedure and was extubated.A couple of hours later the patient crashed.It was found that one of the leaflets was not working.The leaflet was stuck open causing wide open ai.The patient was emergently taken back to the operating room and a 3rd sapien valve was implanted with good results.The patient was stable at the end of the procedure and was reported to be doing great on the next day.After review the team felt that the 2nd valve position was a little bit lower than initially thought, causing the 1st valve leaflets to overhang above the 2nd valve and affecting this valve function.

Manufacturer Narrative

Per the instructions for use (ifu), ventricular malposition with central regurgitation 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 malposition, 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 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 malposition (i.E.Small, calcified stj, minimal leaflet calcification), bav may provide indication of potential balloon movement during valve deployment edwards lifesciences documented on a technical summary the results of testing performed by edwards to study low sapien thv deployment with resulting aortic regurgitation.This clinical event was investigated by examining clinical imaging video which led to an identification of native leaflet overhang over the thv implant.This condition was simulated on the bench to examine the variables that would prevent one or more leaflets from closing during diastole.Based on the analysis of the video and subsequent in vitro testing, it is evident that low placement can lead to native leaflet overhang.However, the overhanging leaflet must be fairly mobile (not heavily calcified) and the position of the overhang relative to the leaflet and commissures may also be important in causing regurgitation.This may explain why low placement can occur without regurgitation.Imaging of the procedure was not available for edwards lifesciences to review.Without imaging, patient factors (native valve calcification), and procedural factors (imaging intensifier angle, valve deployment position, confirmation of leaflet motion restriction or overhang) could not be confirmed/assessed.In this case, the cause of the reported sapien leaflet not moving post procedure with subsequent wide open ai cannot be confirmed; however, per report after discussing the case it was felt that the 2nd valve position was lower than initially thought, causing the 1st valve leaflets to overhang over the 2nd sapien valve.This supports a conclusion that the event was likely caused by the mechanism explained in the technical summary mentioned above.The device was not available for evaluation; however, there was no allegation or indication that the event was related to a manufacturing non-conformance.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; therefore, no further actions are required.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.This is one of two reports being submitted for this case.Please reference manufacturer report no.2015691-2014-00208.

• Brand Name: EDWARDS 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: 3602215
• MDR Text Key: 4091296
• Report Number: 2015691-2014-00209
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2014

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: 04/30/2015
• Device Model Number: 9000TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2014
• Initial Date FDA Received: 01/31/2014
• Date Device Manufactured: 05/15/2013
• 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: 86 YR