MAUDE Adverse Event Report: EDWARDS LIFESCIENCES LLC EDWARDS SAPIEN 3 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 12/19/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation is still ongoing.

Event Description

As reported by a field clinical specialist (fcs), during a tavr procedure with a 26mm sapien 3 ultra valve in the aortic position, there was difficulty pushing the valve through the 14 fr esheath plus.The surgeon pushed very hard through it and was able to get through.At that point it was noticed on flouro that the valve had damage.Three prongs of the valve frame were bent in the wrong direction.The valve was already positioned on the balloon for deployment.The team withdrew the valve back into the esheath and removed the complete system together and replaced with a 16fr esheath.There were no patient injuries reported.

Manufacturer Narrative

A supplemental mdr is being submitted due to engineering evaluation findings, sections g6, h2, h6: type of investigation, investigation findings, investigation conclusions and h10 has been added.The events reported are 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 for evaluation.The returned device was visually examined for any abnormalities and the following was observed; the crimped valve had three (3) struts bent at the inflow side.Post-expansion; the leaflets were wrinkled and dehydrated due to storage condition (prolonged crimping) during the return handling process.The frame was distorted.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.The complaint for frame damage was confirmed based on returned device evaluation.Available information suggests patient factors (calcification, tortuosity) and/or procedural factors (steep insertion angle, excessive manipulation/high push force) likely contributed to the event as it was reported that the angle of insertion was 'questionable' when asked if it was steep.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.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 at the valve inflow side.In addition, assessment of the detailed instructions for use (ifu), device preparation training manuals, and procedural use training manual revealed no identifiable deficiencies.These mitigations (from manufacturing and the ifu/training manual) as identified in the technical summary are still in place to mitigate this issue.As such, available information suggests that patient factors (calcification, tortuosity) may have contributed to the reported resistance while patient factors (calcification, tortuosity) and/or procedural factors (excessive manipulation) may have contributed to the issue of unable to track system through anatomy and delivery system leakage.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 TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee van dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 18499892
• MDR Text Key: 333109652
• Report Number: 2015691-2024-00326
• Device Sequence Number: 1
• Product Code: NPT
• UDI-Device Identifier: 00690103201338
• UDI-Public: (01)00690103201338(17)260803
• 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: 03/15/2024

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: 9750TFX26A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 03/13/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/18/2023
• 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