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

Model Number 9600TFX26

Device Problem Malposition of Device (2616)

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

Event Date 08/09/2022

Event Type  Injury  

Event Description

As reported, it was a valve in valve (viv) case of a 26 mm sapien 3 ultra valve into a non-ew 27 mm valve, on mitral position by transfemoral approach.During the deployment of the 26mm s3u valve, a jump occurred in the last seconds of release causing a little drop of the valve to the ventricle.No paravalvular leak (pvl) was noted, but it was considered that it was a high risk of embolization.It was decided to implant a second valve.An optimal result of mg of 1 mmhg was achieved without causing any injury to the patient.Patient was stable condition.As per medical opinion, the perceived root cause of the event was the pressure applicated in the last 5 ml of the volume.

Manufacturer Narrative

The investigation is ongoing.The device remains implanted.

Manufacturer Narrative

A supplemental mdr is being submitted for additional information.The following sections of this report have been updated: added new information to h.6 type of investigation, investigation findings investigation conclusions.The device was not returned to edwards lifesciences for evaluation.Without the device returned for evaluation, visual inspection, functional testing and dimensional analysis were unable to be completed.A review of the risk management documentation was performed, and no evidence of product non-conformances or labeling/ifu inadequacies were identified in the evaluation.The complaint was unable to be confirmed due to unavailability of relevant imagery/medical report.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, ''during the release of the 26mm s3u valve, a jump occurred in the last seconds of release, generating a little drop of the valve to the ventricle.'' per provided medical opinion, ''the perceived root cause of the event was the pressure application in the last 5 ml of the volume.''.Per training manual, ''release delivery system tension prior to deployment by ensuring thv is coaxial within annulus on final position.'' tension in the system may build up during ds tracking/navigation through patient anatomy as a result of tortuous anatomy.If the stored tension was not released prior to thv deployment (procedural factors), it could have caused sudden delivery system movement, resulting in ventricular thv shift, as reported.In this case, the patient's access vessel condition was unknown, so the presence of tortuosity could not be confirmed and therefore, a definitive root cause was unable to be determined.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/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: PROSTHESIS, MITRAL VALVE, 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: 15330764
• MDR Text Key: 299038682
• Report Number: 2015691-2022-07635
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140031
• 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
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2024
• Device Model Number: 9600TFX26
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/26/2022
• 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: Male