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

Model Number 9300TFX29

Device Problem Leak/Splash (1354)

Patient Problem Pulmonary Regurgitation (2023)

Event Date 08/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Per the instructions for use, valve regurgitation is a potential adverse event associated with bioprosthetic heart valves and the transcatheter pulmonary valve replacement (tpvr) procedure.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 native valve leaflet assessment, taking into consideration the length, bulkiness and distribution of calcium on the native leaflets to determine whether valve performance will be impaired.In this case, per the physician, the regurgitation was related to the second stent placement, which prevented the sapien 3 leaflets from coapting properly.There was no allegation of a device malfunction.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 notified by implant patient registry (ipr), a valve in valve procedure was performed more than 1 year post initial implant of the 29 mm sapien 3 valve in the pulmonic position.Prior to the initial placement of the 29 mm sapien 3, the pulmonary valve was pre-stented, as the physician felt the native pulmonary valve was too large for the sapien 3 valve.Despite the pre-stenting, post deployment, the 29 mm sapien 3 slightly migrated towards the rvot.In order to stabilize the migrating 29 mm s3, the physician placed a second stent distal to the sapien 3 valve (to keep the valve in place).However, the second stent prevented the sapien 3 leaflets from coapting properly, causing pulmonary regurgitation.The physician decided to monitor the patient and bring her back in a year to place a second valve.The second valve was placed 15 months post initial valve procedure, with no reported injury to the patient.There was no edwards device malfunction.As per the physician, the event was attributed to the native pulmonary valve being too large to effectively ¿hold¿ the pre-stent and/or bioprosthetic s3 in place.

Event Description

As notified by implant patient registry (ipr), a valve in valve procedure was performed more than 1 year post initial implant of the 29mm sapien xt valve in the pulmonic position.Prior to the initial placement of the 29mm sapien xt, the pulmonary valve was pre-stented, as the physician felt the native pulmonary valve was too large for the sapien xt valve.Despite the pre-stenting, post deployment, the 29mm sapien xt slightly migrated towards the rvot.In order to stabilize the migrating 29mm sapien xt, the physician placed a second stent distal to the sapien xt valve (to keep the valve in place).However, the second stent prevented the sapien xt leaflets from coapting properly, causing pulmonary regurgitation.The physician decided to monitor the patient and bring her back in a year to place a second valve.The second valve was placed 15 months post initial valve procedure, with no reported injury to the patient.There was no edwards device malfunction.As per the physician, the event was attributed to the native pulmonary valve being too large to effectively ¿hold¿ the pre-stent and/or bioprosthetic sapien xt in place.

Manufacturer Narrative

An administrative review of 3500a forms posted on the maude database showed this manufacturer report was submitted with the incorrect common device name an product code.A correction to field d2 is being submitted in this supplemental report.

• Brand Name: EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE
• Type of Device: PULMONARY 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: frances preston ; 1 edwards way; irvine, CA 92614 ; 9492505190
• MDR Report Key: 6861485
• MDR Text Key: 85942272
• Report Number: 2015691-2017-02901
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2017

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: 10/16/2016
• Device Model Number: 9300TFX29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/13/2017
• Supplement Dates Manufacturer Received: 11/15/2017; 11/29/2021
• Supplement Dates FDA Received: 11/16/2017; 12/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2014
• 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: 21 YR
• Patient Sex: Female