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

Model Number 9600TFX29A

Device Problems Fluid/Blood Leak (1250); Difficult to Open or Close (2921)

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

Event Date 02/08/2022

Event Type  Injury  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.The investigation is still ongoing.

Event Description

As reported by the field clinical specialist (fcs), during a transseptal tmvr procedure of a 29mm sapien 3 valve inside a non-edwards surgical valve, one leaflet was not moving and central leak was observed.A second sapien valve was implanted.

Manufacturer Narrative

A supplemental mdr is being submitted based on additional information.The following section of this report has been updated: section h10 (provide narrative/data).This is one of two manufacturer reports being submitted for this case.Please reference manufacturer report no: 2015691-2022-04275.The investigation is still ongoing.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and additional information based on investigation.The device was not returned to edwards lifesciences for evaluation as it remains implanted.As a result, a visual inspection, functional testing and dimensional analysis were unable to be completed.A device history record (dhr) review was performed and did not reveal any manufacturing nonconformance issues that would have contributed to the event.The instructions for use (ifu)/training manuals were reviewed for guidance/instruction involving the valve and delivery system usage.Per ifu and training manuals: note: exact volume required to deploy the thv may vary depending on the prosthesis inner diameter.Factors such as calcification and pannus tissue growth may not be accurately visualized in imaging and may reduce the effective inner diameter of the failing prosthesis to a size smaller than the 'true id'.These factors should be considered and assessed in order to determine the most appropriate thv size to achieve nominal thv deployment and sufficient anchoring.Do not exceed the rated burst pressure.Note: the delivery system requires a prescribed volume for thv deployment and proper function.The nominal inflation volume is 33ml for a nominal balloon diameter of 29mm.Based on the review of the ifu/training manuals, no deficiencies were identified.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.The events for leaflet motion restricted and deployed valve exhibits central regurgitation were unable to be confirmed due to unavailability of relevant imagery/medical records.A review of the dhr did not provide any indication that a manufacturing non-conformance contributed to the event.A review of ifu/training materials revealed no deficiencies.During the manufacturing process, all edwards 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 event description states 'during a transseptal tmvr procedure of a 29mm sapien 3 valve, the valve had one leaflet not moving and central leak was observed.In addition, the balloon burst during inflation'.As noted, an additional 3cc of inflation volume was used during the valve deployment.Overexpansion may cause stretching on leaflets resulting in restricted leaflet motion and central leakage.In this case, available information suggests that procedural factors (over expansion of the valve) may have contributed to the events.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 product risk assessment nor corrective or preventative actions are required.

• 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: 13673414
• MDR Text Key: 289532947
• Report Number: 2015691-2022-04273
• Device Sequence Number: 1
• Product Code: NPU
• UDI-Device Identifier: 00690103194364
• UDI-Public: (01)00690103194364(17)230712
• 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,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2023
• Device Model Number: 9600TFX29A
• Device Catalogue Number: 9600TFX29A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/29/2021
• 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: Male