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

Model Number 9600TFX29

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2021

Event Type  Injury  

Manufacturer Narrative

Per the instructions for use (ifu), valve migration requiring intervention is a potential adverse event associated with transcatheter 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 aortic wall.Stent valves are subjected to antegrade ejection forces during systole the edwards thv patient screening manual advises the operator on pre-procedure assessment of the aortic 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, there was no allegation or indication a device malfunction contributed to this adverse event.The information provided indicates the valve migration post deployment may have occurred as a result of the pre-existing stent fracturing during deployment.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 by the edwards european affiliate, the patient underwent implant of a 29 mm sapien 3 valve in the pulmonic position.The valve was deployed with an extra 2 ml of volume and was successful within a non-edwards 30x55 mm stent implanted 6 months prior.Before the valve performance could be assessed with contrast, it was noted that the valve was sliding towards the right ventricle.The physician believes the stent fractured during deployment of the s3 valve, causing non-complete adhesion of the s3 valve to the stent and resulted in it sliding towards the right ventricle.The decision was made to implant a second 29 mm sapien 3 valve with nominal volume + 5 ml, in a more distal position, by overlapping the valve already implanted.The case was successful.The patient is fine.

• 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: 12318858
• MDR Text Key: 266412788
• Report Number: 2015691-2021-04662
• Device Sequence Number: 1
• Product Code: NPV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P200015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2023
• Device Model Number: 9600TFX29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2021
• 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 Age: 45 YR