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

Model Number EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE

Device Problem Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 12/27/2021

Event Type  Injury  

Event Description

As reported by the edwards european affiliate through the review of the article: ''modified technique of percutaneous pulmonary valve implantation with the sapien 3: impact on procedure and early outcome.'' percutaneous pulmonary valve implantation (ppvi) with a sapien 3 valve is effective to treat right ventricle outflow dysfunction.Instability of the valve was observed in one case which was stabilized with two stents and an additional valve-in-valve implantation.

Manufacturer Narrative

Citation: houeijeh, a., et al.''modified technique of percutaneous pulmonary valve implantation with the sapien 3: impact on procedure and early outcome.'' archives of cardiovascular diseases supplements 14.1 (2022): 116.Investigation is ongoing.Valve remains implanted.

Manufacturer Narrative

Corrected d.2, g.4, and h.6 investigation fields.The device was not returned for evaluation.During manufacturing of the sapien 3 transcatheter heart valve, the valve and components are inspected several times throughout the manufacturing process.In addition, product verification testing was performed on a sampling basis and all testing met specifications.These inspections performed during manufacturing process and testing performed during product verification support that it is unlikely that a manufacturing non-conformance contributed to the reported events.Per the article, the exact procedure date and used delivery system are unknown.Based on the article publication date, ifu review using commander delivery system was performed.In addition, noted that the sapien 3 was implanted in the native pulmonary valve.The sapien 3 (s3) was indicated in patients with a dysfunctional, previously repaired or replaced noncompliant right ventricular outflow tract/pulmonary valve (rvot/pv) or previously implanted valve in the pulmonic position.Therefore, it is considered off-label operation.The ifu/training manual were reviewed for relevant guidance with respect to the sapien 3 (s3) thv using a commander delivery system in pulmonic position.Correct sizing of the thv is essential to minimize the risk of paravalvular leak, migration, valve embolization and/or rvot rupture.Potential risks associated with the valve, delivery system and/or accessories include, but may not be limited to, the following: device acute migration or malposition requiring intervention.During thv positioning, place the thv completely within the landing zone.Avoid positioning the distal (outflow) half of the thv within any residual stenosis which may affect proper leaflet function.Use different fluoroscopic views, if uncertain about positioning.Placement of the thv in the proximity of stenosis can result in thv movement during deployment.Use the fine adjustment wheel to control fine positioning of the thv.Ensure the flex tip is pulled back to the middle of the triple marker.Ensure the balloon lock is locked.Turn the fine adjustment wheel to finely control the thv position in either direction.Prior to deployment check to ensure the thv is exactly between the valve alignment markers, flex tip is on the triple marker, and balloon lock is locked.Perform thv deployment.Unlock the inflation device and confirm thv position.Begin initial deployment with a slow, controlled inflation.Reposition thv as necessary.Fully inflate and hold for 3 seconds to ensure complete deployment.Completely deflate the balloon and withdraw the balloon.Slow inflation during initial deployment may help with stability of the delivery system and thv during deployment.Post-deployment thv assessment is done by assessing the valve post-deployment using fluoroscopy.Withdraw the delivery system from the valve before assessing.Perform post angiogram with wire still in position to assess valve position and expansion, patency of coronary arteries, and functional assessment of the valve (central leak, pvl, etc.).No ifu/training deficiencies were identified.Complaint histories for all reported events are reviewed against trending control limits monthly, and any excursions above the control limits are assessed and documented as part of this monthly review.A review of edwards lifesciences risk management documentation was performed for this case.The reported event is an anticipated risk of the transcatheter heart valve procedure, additional assessment of the failure mode is not required at this time.Since no device problem was identified affecting distributed product, no pra is required.Since no edwards defects and/or ifu deficiencies were identified, no corrective or preventative actions are required.The valve malposition was unable to be confirmed due to unavailability of relevant medical record.The reported event does not allege a malfunction that could be related to an edwards manufacturing deficiency.A review of ifu/training materials revealed no deficiencies.As reported through the article, ''instability of a valve was observed in one case which was stabilized with two stents and an additional valve-in-valve implantation''.Per the instructions for use (ifu), device malposition requiring intervention is a potential adverse event associated with the transcatheter pulmonic valve replacement procedure.The training manual instructs the operator to position the valve completely within the landing zone and avoid placing the valve in the proximity of stenosis to prevent valve movement during deployment.In addition, the training manual instructs the user to take pre-stenting into considerations to achieve a better landing zone for valve.Due to insufficient information, a definitive root cause is unable to be determined.

• Brand Name: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92646
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 16179293
• MDR Text Key: 307495426
• Report Number: 2015691-2023-10219
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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