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

Model Number 9300TFX26A

Device Problems Leak/Splash (1354); Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problem Aortic Insufficiency (1715)

Event Date 04/17/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Per the instructions for use (ifu), valve malposition and regurgitation are known potential complications 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 valve malposition/embolization, including, but not limited to, improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, loss of pacing capture, rapid deployment and movement of the delivery system by the operator.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve regurgitation including, but not limited to, malposition of the valve, inaccurate measurement of the native valve annulus, uneven distribution of calcium on the native valve, bulky or severe calcification, a severely elliptical annulus shape, valve under-sizing.During the manufacturing process, all sapien valves are 100% visually inspected for defects and 100% tested for coaptation prior to release for distribution.This makes it highly unlikely that a manufacturing defect or device malfunction would contribute to the event.In this case, the exact cause of the valve malposition and subsequent regurgitation could not be confirmed.However, per report, on deployment, the stricture caused the valve to watermelon seed into the rvot and drag the palmaz stent with it.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, during a transvenous tavr procedure in the pulmonic position, during deployment, the valve ¿watermelon seeded¿ into the rvot, which resulted in wide open paravalvular leak (pvl) and central pulmonic insufficiency (cpi).A second valve was deployed.Initially the patient received a pulmonic stent.After sizing with 20, 22, 25 bav balloon the team decided to place the pulmonic stent (40x10x2) with the 25x6 zmed balloon.After the pulmonic palmaz stent was placed, it was decided to proceed with the deployment of a 26mm sapien xt valve.On deployment,a ¿stricture¿ caused the valve to ¿watermelon seed¿ into the rvot and dragged the palmaz stent with it, which resulted in wide open pvl and cai.The team deployed a second palmaz stent (10x40x2) to anchor the 26mm sapien xt in place and follow with the deployment of a second thv valve.A 23mm sapien xt valve was successfully deployed.Repeat echo showed pvl and cai had resolved to none.The patient left in stable condition.

Manufacturer Narrative

The valve remains implanted and was therefore not returned to edwards for evaluation.  per the instructions for use (ifu), valve malposition and regurgitation are known potential complications associated with the transcatheter valve replacement (tvr) procedure.  there are multiple patient and procedural factors that alone or in combination can cause or contribute to valve malposition, including, but not limited to, improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, loss of pacing capture, rapid deployment and movement of the delivery system by the operator.  the patient's anatomy should be evaluated to prevent the risk of access that would preclude the delivery and deployment of the device.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve regurgitation including, but not limited to, malposition of the valve, inaccurate measurement of the native valve annulus, uneven distribution of calcium on the native valve, bulky or severe calcification, a severely elliptical annulus shape, valve under-sizing.  the thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.  the patient screening manual instructs the operator on proper anatomy assessment, taking into consideration the length, bulkiness and distribution of calcium present on the native leaflets to determine whether valve performance will be impaired.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.   the exact cause of the valve malposition and subsequent regurgitation could not be confirmed.   however, per report, on deployment, the stricture caused the valve to watermelon seed into the rvot and drag the palmaz stent with it.     the edwards sapien xt transcatheter heart valve is indicated for use in pediatric and adult patients with a dysfunctional, non-compliant right ventricular outflow tract (rvot) conduit with a clinical indication for intervention and pulmonary regurgitation >= moderate and/or mean rvot gradient >= 35 mmhg.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, during a transvenous approach for sapien xt in the pulmonary position, during deployment, the valve ¿watermelon seeded¿ into the rvot, which resulted in wide open paravalvular leak (pvl) and central pulmonic insufficiency (cpi).   a second valve was deployed.  initially the patient received a pulmonic stent.  after sizing with 20, 22, 25 bav balloon the team decided to place the pulmonic stent (40x10x2) with the 25x6 zmed balloon.  after the pulmonic palmaz stent was placed, it was decided to proceed with the deployment of a 26mm sapien xt valve.  on deployment,a ¿stricture¿ caused the valve to ¿watermelon seed¿ into the rvot and dragged the palmaz stent with it, which resulted in wide open pvl and cpi.  the team deployed a second palmaz stent (10x40x2) to anchor the 26mm sapien xt in place and follow with the deployment of a second thv valve.  a 23mm sapien xt valve was successfully deployed.  repeat echo showed pvl and cai had resolved to none. the patient left in stable condition.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 6509926
• MDR Text Key: 73331105
• Report Number: 2015691-2017-01069
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2019
• Device Model Number: 9300TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2017
• 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: 44 YR