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

Model Number 9750TFX23

Device Problem Material Deformation (2976)

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

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.

Event Description

As reported by our edwards affiliate in canada, it was an implant of a 23mm sapien 3 ultra transcatheter heart valve in aortic position by transfemoral approach.The 14fr esheath was inserted without issues, however, for valve insertion, it remained stuck in the non expandable portion of the esheath and it could not be advanced further.Multiple attempts were made without success.The commander delivery system kinked upon insertion of the valve inside the esheath.On fluoro, it was apparent that the valve was no longer in its originally crimped position on the catheter, therefore, it was decided to retract the devices and prep another valve.The esheath, commander system and crimped valve were removed as a single unit and discarded.A new esheath was prepped and inserted, followed by a new 23mm s3u valve which was deployed at the desired location.No harm for the patient.As per picture provided, a bent valve strut could be observed.

Manufacturer Narrative

The event reported is in the risk management documentation for transcatheter heart valve procedures.A previous investigation into this type of event is captured in an edwards lifesciences technical summary and applies to this complaint.Additional assessment of the failure mode is not required at this time.The device was returned for evaluation.Per visual evaluation of the device three valve struts were bent at the inflow side.Provided imagery also showed bent struts.Per the technical summary, the ifu, current risk mitigations include design and manufacturing controls, and training manuals have been reviewed, no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.In this case the valve frame damage was confirmed based on evaluation of the returned product evaluation and provided imagery.Available information suggests that procedural factors (excessive device manipulation, high push force) may have caused/contributed to the reported event.Excessive device manipulation or high push force can lead to the valve struts interacting with the sheath shaft and result in the strut damage at the valve inflow side.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.Since no edwards product defects or labeling deficiencies were identified, no corrective or preventative action is required.

• Brand Name: EDWARDS SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE
• Type of Device: AORTIC 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: 18268791
• MDR Text Key: 329745731
• Report Number: 2015691-2023-17937
• Device Sequence Number: 1
• Product Code: NPT
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/26/2024
• Device Model Number: 9750TFX23
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/10/2023
• Initial Date FDA Received: 12/05/2023
• Supplement Dates Manufacturer Received: 02/12/2024
• Supplement Dates FDA Received: 02/12/2024
• 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 Age: 77 YR
• Patient Sex: Female