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

Model Number 9755RSL29A

Device Problem Material Deformation (2976)

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

Event Date 01/24/2024

Event Type  malfunction  

Manufacturer Narrative

This is one of two manufacturer reports being submitted for this case.Please reference manufacturer report number 2015691-2024-02609 for details of the other event.The investigation is ongoing.

Event Description

As reported by the field specialist, during the transfemoral transcatheter aortic valve replacement (tavr) with a 29 mm sapien 3 ultra resilia valve, the commander delivery system with valve was being advanced through the 16fr esheath+ and after the system had been advanced out of the loader, high resistance was felt.The resistance was noted between the strain relief and sheath shaft.An assessment of the valve was performed to determine if a strut had extended.A 90-degree angle for viewing was also used to determine if the strut had extended.There was no strut extension noted.Subsequently, an attempt was made again to advance the delivery system with valve when a strut was observed starting to extend away from the frame.Advancement of the delivery system with valve through the esheath+ was stopped and the entire system was withdrawn as a single unit without any issues.A new 16fr esheath+ was then prepared along with a new delivery system and a 29 mm sapien 3 valve.The second delivery system with second valve was able to be advanced smoothly through the second esheath+.The procedure was completed successfully without any complications.There was no patient injury.The first esheath+ was returned for evaluation.Evaluation of the returned device revealed the sheath had a loss of integrity.There was a liner tear approximately 4.5 cm in length.The liner tear began approximately 2.75 cm from the strain relief.Stretching was also noticed at the tear region approximately 7.25 cm in length.The stretching began at approximately 1.5 cm from the strain relief.Additionally, multiple liner strands were observed in the stretching region.

Manufacturer Narrative

A supplemental mdr is being submitted for correction and includes additional information based on investigation.The event reported is anticipated 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 to edwards lifesciences for evaluation.Visual evaluation of the returned device revealed one (1) strut bent outward at the inflow side.Subsequently, the returned crimped valve was expanded, and the bent strut corrected.The valve frame was noted to be distorted.Additionally, the leaflets were noted to be wrinkled and dehydrated due to the storage condition (prolonged crimping) during the return handling process.Per the technical summary, the instructions for use (ifu), current risk mitigations that 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 device.The available information suggests procedural factors (excessive device manipulation and high push force) likely contributed to the event as it was reported during advancement of the commander delivery system with valve through the 16fr esheath+ that there was high resistance felt after the system had been advanced out of the loader.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.A product risk assessment (pra) was previously initiated for this type of event.Further assessment revealed the control limits were not exceeded.As such, no corrective or preventative actions are required at this time.

• Brand Name: EDWARDS SAPIEN 3 ULTRA RESILIA 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: 19051411
• MDR Text Key: 340100475
• Report Number: 2015691-2024-02611
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103215823
• UDI-Public: (01)00690103215823(17)260521(11)230522
• 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: 05/09/2024

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 Model Number: 9755RSL29A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/11/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• 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 Sex: Female