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

Model Number 9600TFX23A

Device Problems Perivalvular Leak (1457); Malposition of Device (2616)

Patient Problem Insufficient Information (4580)

Event Date 01/10/2022

Event Type  Injury  

Manufacturer Narrative

The investigation is ongoing.The device remains implanted.

Event Description

As reported, during the procedure of a 23 mm sapien 3 valve in the pulmonic position in a conduit via transfemoral approach, it was felt the true waist was missed by 25% and a second valve would seal the leak.Mild paravalvular leak (pvl) was noted and no central pulmonary insufficiency (pi).The patient was in stable condition.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information base on the engineering evaluation.The following sections of this report have been updated: corrected h.6 impact code and investigation conclusions and added new information to h.6 type of investigation and investigation findings.The sapien 3 valve was not returned to edwards lifesciences for evaluation, as it remains implanted int he patient.Imagery was not provided for review.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.The instructions were reviewed instruction for use (ifu) for commander delivery system with s3, pulmonic and device preparation manual and no ifu/training deficiencies were identified.The ifu for commander delivery system with s3, pulmonic provide guidance on potential adverse event such as device acute migration or malposition requiring intervention.The procedural training manual provides guidance on thv positioning.Avoid positioning the distal (outflow) half of the thv within any residual stenosis which may affect proper leaflet function.Placement of the thv in the proximity of stenosis can result in thv movement during deployment.A review of the risk management documentation was performed, and 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.The complaints were unable to be confirmed due to unavailability of procedural imagery.No potential manufacturing non-conformance were identified during the evaluation.A review of ifu/training materials revealed no deficiencies.In this case, it was reported that 'during the procedure of a 23 mm sapien 3 valve in the pulmonic position in a conduit via transfemoral approach, it was felt the true waist was missed by 25% and a second valve would seal the leak.A second valve was prepped and deployed 90:10 to the first.Post dilated with a 23 true balloon.Ice was used to determine mild pvl noted.No central pi.No other complications noted; patient in stable condition'.Per the instructions for use (ifu), device migration or malposition requiring intervention is a potential adverse event associated with the transcatheter pulmonic valve replacement procedure.The ifu instructs the operator to position the valve completely within any previously placed stents or conduits, and notes that placing the bioprosthesis proximal to a stenosis can result in proximal movement of the bioprosthesis.For placement proximal to stenotic lesions, the operator is instructed to ensure that there is sufficient landing zone to allow for proximal movement of the bioprosthesis during deployment.There are several patient and procedural factors that alone or in combination can cause or contribute to an inadequate post deployment position of the valve including: improper positioning before deployment, poor image intensifier angle, poor coaxial alignment of the valve and delivery system, minimally or bulky/severely calcification in the landing zone, rapid deployment, the release of stored tension during deployment, and movement of the delivery system by the operator.In this case, it was also reported 's3 implanted in what appeared to be an adequate position in relationship to the calcification' and when the valve was deployed, 'true waist was missed by 25%'.As such available information suggests that patient factor (calcification in the landing zone) and/or procedural factors (improper positioning of valve) may have contributed to the valve malposition.However, a definitive root cause is unable to be determined.A malpositioned valve may prevent proper sealing of the valve against the landing zone resulting in paravalvular leak.As such, available information suggests that procedural factors (thv malposition) may have contributed to the complaint event.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.No ifu, labeling and training manual inadequacies were identified.Therefore, no corrective or preventative action nor product risk assessment is required at this time.

• Brand Name: SAPIEN 3 TRANSCATHETER HEART VALVE
• Type of Device: PULMONARY VALVE PROSTHESIS PERCUTANEOUSLY DELIVERED
• 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: 13385259
• MDR Text Key: 286262940
• Report Number: 2015691-2022-03678
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103194340
• UDI-Public: (01)00690103194340(17)230405
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2022

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: 04/05/2023
• Device Model Number: 9600TFX23A
• Device Catalogue Number: 9600TFX23A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2022
• Initial Date FDA Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2021
• 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 Sex: Female