MAUDE Adverse Event Report: EDWARDS LIFESCIENCES US S3 UR VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number 9755RSL26A

Device Problem Material Deformation (2976)

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

Event Date 10/23/2023

Event Type  malfunction  

Event Description

As reported by a field clinical specialist, a patient underwent a transfemoral tavr procedure with a 26mm sapien 3 ultra resilia valve in aortic position.During the procedure, a strut frame on the valve was found to be bent as the team exited the esheath.The patient had very tortuous anatomy, so the physician decided to remove everything and start with a new valve.The new valve was implanted successfully.Per follow-up with the fcs, there was no difficulty inserting the sheath into the patient.There was no loss of integrity or damage of the sheath.The implanter did have to push a little more than usual, but that was accounted for the sharp angle he was trying to push the delivery system with valve through the sheath.It is believed the root cause for the bent strut was due to pushing the delivery system through the sheath at a sharp angle.There was no patient injury and no additional edwards devices were damaged.The devices were discarded.

Manufacturer Narrative

Investigation is ongoing.H3 other text : discarded.

Manufacturer Narrative

The device was not returned to edwards lifesciences for evaluation.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 this event is not required at this time.The complaint for "frame damage" was unable to be confirmed based on unavailability of device/relevant imagery.Available information suggests patient factors (tortuosity) and/or procedural factors (steep insertion angle, excessive manipulation/high push force) likely contributed to the event as it was reported, "the patient had very tortuous anatomy," and "it is believed the root cause for the bent strut was due to pushing the delivery system through the sheath at a sharp angle." tortuous patient anatomy can create sub-optimal angles that can lead to non-coaxial alignment between the delivery system with crimped valve and sheath inner lumen.A steep insertion angle can result in non-coaxial alignment between the delivery system and sheath.Non-coaxial advancement of the delivery system through the sheath may lead to resistance.Excessive device manipulation or high push force can lead to the valve struts interacting with the sheath shaft and result in the strut damage on the valve.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.As such, neither a product risk assessment, nor corrective or preventative actions are required at this time.

• Brand Name: US S3 UR 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: 18167396
• MDR Text Key: 328658862
• Report Number: 2015691-2023-17604
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103215816
• UDI-Public: (01)00690103215816(17)260501(11)2305022110499894
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/02/2024

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: 9755RSL26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2023
• Initial Date FDA Received: 11/19/2023
• Supplement Dates Manufacturer Received: 12/12/2023
• Supplement Dates FDA Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2023
• 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