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

Model Number 9750TFX26A

Device Problem Material Deformation (2976)

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

Event Date 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is ongoing.This is one of two manufacturer reports submitted for this case.H3 other text : not returned for evaluation.

Event Description

As reported by the field specialist, during a transfemoral tavr procedure with a 26 mm sapien 3 ultra valve, the valve was unable to advance in the 14fr esheath due to a calcified 4.4 x 6.6 external iliac measurement.The iliac was dilated with the esheath 16fr dilator beforehand.The stent struts were bent on the valve and appear to have gone through the side wall of sheath.This was noticed inside the patient.The struts bent when the valve was pushing through the sheath and got caught on the calcified artery.The main damage to the sheath was done when pulling the valve back while inside the sheath to realign it for a different push position.It was decided to pull everything out as a unit and start over with a new 14fr esheath, 26 mm commander delivery system, and a 26 mm sapien 3 ultra valve.The 2nd 14fr sheath was delivered, along with the 2nd valve.There was some trouble pushing, but the valve successfully passed the calcified area and was deployed as well.No access vessel complications were noted, and the procedure was completed successfully.A photo of the devices after use shows the first delivery system with the valve exiting the side of the sheath through the liner.

Manufacturer Narrative

A supplemental mdr is being submitted for the completed engineering evaluation.Sections b.4, g.3, g.6, and h.2 have been updated.Corrections have been made to h.6 type of investigation, investigation findings and investigation conclusion.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 not returned for evaluation.Due to the unavailability of the complaint device, engineering was unable to perform any visual inspection, functional testing, or dimensional analysis.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.A review of the imagery provided (photo showing the device after removal from the patient) was performed and the following was observed: two (2) bent struts at the outflow, and one (bent strut) at inflow.The complaint for frame damage was confirmed based on the provided imagery.Available information suggests patient factors (calcification) and/or procedural factors (excessive manipulation/high push force) likely contributed to the event as it was reported, ''the struts bent when the valve was pushing through the sheath and got caught on the calcified artery.'' per imagery review, bent struts were observed on the outflow and inflow side of the valve.It is likely that the struts on the inflow side were damaged as a result of interaction with calcification during the delivery system insertion.The struts on the outflow side were likely damaged due to excessive manipulation as the valve was pulled back while inside the sheath.Excessive device manipulation or high push force can lead to the valve struts interacting with the sheath shaft and result in strut damage at the valve outflow/inflow side.Calcification can reduce the vessel lumen diameter and may increase restriction leading to resistance.Calcification can also result in the creation of sub-optimal angles during delivery system insertion that may lead to resistance.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.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: 18107398
• MDR Text Key: 328673666
• Report Number: 2015691-2023-17375
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)260424
• 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: 12/21/2023

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: 9750TFX26A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/17/2023
• Initial Date FDA Received: 11/09/2023
• Supplement Dates Manufacturer Received: 12/11/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• 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: Male