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

Model Number 9600TFX26A

Device Problem Migration (4003)

Patient Problem Insufficient Information (4580)

Event Date 11/10/2020

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), valve migration requiring intervention is a potential adverse event associated with transcatheter pulmonary valve replacement.According to literature review, valve migration results when forces acting on the transcatheter heart valve (thv) overcome the strength of attachment of the valve to the pulmonary wall.Stent valves are subjected to antegrade ejection forces during systole.Less than severe and non uniformly distributed calcification of the native leaflets, incorrect bioprosthetic valve sizing, and incomplete frame expansion, can contribute to valve migration.Additionally, residual overhanging leaflets can exert downwards force during diastole, causing migration of the thv towards the left ventricle.The edwards thv patient screening manual advises the operator on pre procedure assessment of the pulmonary valve and root, taking into consideration the degree and distribution of native leaflet calcification.The procedural didactic instructs 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 transcatheter heart valve (thv).Training includes patient screening, device preparation, approach, deployment, imaging, procedure specific training manuals and proctored procedures.The correct sizing, alignment and positioning of the device are emphasized as key factors to the placement and fixation of the device.In this case, the cause of the migration cannot be confirmed, however, investigation results suggest/indicate that patient and/or procedural factors may have contributed to the valve migration towards mpa bifurcation.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, post valve in valve procedure with a 26mm sapien 3 valve in a surgical valve in the pulmonic position, the sapien 3 valve 'migrated towards mpa bifurcation.' a stent was placed, followed by a non edwards valve within the migrated sapien 3 valve.There were no reports of any complications.

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, product code, pma number, or other missed or incorrect information).A correction to section g4 is being submitted in this supplemental report.

• 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 92614
• 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: 11427082
• MDR Text Key: 238343724
• Report Number: 2015691-2021-01727
• Device Sequence Number: 1
• Product Code: NPV
• UDI-Device Identifier: 00690103194357
• UDI-Public: (01)00690103194357(17)220201
• 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
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2022
• Device Model Number: 9600TFX26A
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2020
• 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: 41 YR
• Patient Sex: Female