MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS SAPIEN 3 TRANSCATHETER; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9600TFX26

Device Problems Perivalvular Leak (1457); Failure to Align (2522); Malposition of Device (2616)

Patient Problems Aortic Regurgitation (1716); No Code Available (3191)

Event Date 08/02/2018

Event Type  Injury  

Manufacturer Narrative

The device is not available for evaluation as it remains implanted in the patient.Per the instructions for use (ifu), valve malposition requiring intervention and paravalvular leak (pvl) are 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 (stj), minimally or bulky/severely calcified aortic leaflets, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.The patient screening manual and the procedure didactic identify several procedural and anatomical factors which could contribute to pvl, including device malposition, inaccurate measurement of the native valve annulus, uneven distribution of calcium on the native valve, bulky or severe calcification, an elliptical annulus shape and valve under-sizing.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.The patient screening manual instructs the operator on proper aortic valve and root assessment, including the use of echo, aortogram and ct to appropriately measure the annulus diameter, content and distribution of calcium, and leaflet characteristics.Contraindications, important considerations when assessing the valve, and choosing the proper thv are also discussed.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results suggest/indicate that improper positioning prior to deployment contributed to the too ventricular valve placement and resulting pvl.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.

Event Description

As reported by our affiliates in (b)(6), during implant of a 26mm sapien 3 valve by subclavian approach, the valve landed in an approximately 60:40 aortic/ventricular (a/v) position and moderate paravalvular leak (pvl) was observed.Post dilation of the valve with nominal inflation volume was considered, but root angio showed moderate plus paravalvular leak over the outer skirt.It was felt that the position was too low to be effectively corrected with post-dilation.A second 26mm sapien 3 valve was placed more aortic, in an approximately 80:20 a/v position and the pvl was then graded trace.The patient was awake and stable throughout the procedure.¿during pacing the position of the heart changed and the marker was no longer lined up correctly¿, resulting in the too ventricular valve placement.The patient¿s native annulus area measured 440mm2.

Manufacturer Narrative

Additional information was received.Section were updated.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7813593
• MDR Text Key: 118154400
• Report Number: 2015691-2018-03540
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2018

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: 05/15/2019
• Device Model Number: 9600TFX26
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/24/2018
• Supplement Dates Manufacturer Received: 09/12/2018; 07/23/2020
• Supplement Dates FDA Received: 09/21/2018; 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR