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

Model Number 9000TFX23A

Device Problems Malposition of Device (2616); Device Operates Differently Than Expected (2913)

Patient Problem Aortic Regurgitation (1716)

Event Date 04/10/2014

Event Type  Injury  

Event Description

In a transapical tavr procedure, after deployment the position of the 23mm sapien valve was too aortic with one of the leaflets not coapting appropriately and there was moderate to severe central aortic insufficiency (cai).A 2nd valve was successfully deployed.The patient has a pre-existing mechanical mitral valve.No defects were noted during device prep.The valve was deployed using a slow inflation technique while rapid ventricular pacing.During deployment the valve moved aortic, but appeared to be stable in an 80:20 (aortic/ventricular) position.The patient went into ventricular fibrillation during rapid pacing and was defibrillated 2 times to restore sinus rhythm.The pressure failed to recover so bypass was initiated.The apical sheath was removed and hemostasis was achieved.When the pressure was restored to a level where the valve was able to be evaluated, it appeared as if the leaflet on the non-coronary side was failing to coapt and there was moderate to severe cai.There was no apparent native leaflet overhang.There was no calcification or thrombus in the ascending aorta.The team attempted multiple maneuvers to attempt to improve coaptation, including nudging it with a pigtail catheter and an additional valvuloplasty through a 12f sheath in the apex with a 22 x 4mm non-edwards balloon.There was no appreciable improvement in the cai following these attempts.A second 23mm sapien valve was prepped as ta access was then gained with an ascendra sheath.The valve was deployed just slightly more ventricular than the first valve and resulted in complete resolution of the aortic insufficiency.The sheath was removed and hemostasis was achieved in the apex.She was weaned off of bypass and transported to the icu in stable condition.Estimated blood loss was 600ml.

Manufacturer Narrative

Investigation of this event is ongoing.

Manufacturer Narrative

Per the instructions for use, device malposition requiring intervention is a known potential adverse event associated with the 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.Per the instructions for use (ifu), arrhythmias are known potential adverse events associated with balloon valvuloplasty, the use of local and/or general anesthesia, aortic valve replacement and the overall tavr procedure.Peri-procedural ventricular arrhythmias can be associated with patient and procedural factors such as poor ventricular function, inadequate coronary perfusion, hypovolemia, annular rupture/ aortic dissection, tamponade, wire and catheter manipulation and burst pacing.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 malposition with subsequent cai was related to the pre-existing bioprosthetic mitral valve causing the sapien valve to move upwards during deployment.It appears that a combination of patient factors (cad and ef=30%) and procedural factors (burst pacing) contributed to the v-fib reported.The device was not available for evaluation, as it remains implanted in the patient.There is no indication that the event was related to a device malfunction.During the manufacturing process, all edwards valves are 100% visually inspected for defects and 100% tested for coaptation prior to release for distribution.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 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 92614
• Manufacturer Contact: deborah deutsch ; 1 edwards way; irvine, CA 92614 ; 9497564213
• MDR Report Key: 3796875
• MDR Text Key: 4380755
• Report Number: 2015691-2014-01049
• 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,Followup
• Report Date: 04/10/2014

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: 05/07/2014
• Initial Date FDA Received: 05/07/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 91 YR
• Patient Weight: 66